Open-label Long-term Extension Study of Fesoterodine in Japanese Subjects With Neurogenic Detrusor Overactivity.

NCT02501928 | Completed Phase 3 Results DMC

• 1 other identifier: A0221109
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to investigate the safety and tolerability of fesoterodine following once daily long-term treatment in Japanese pediatric neurogenic detrusor overactivity (NDO) subjects.

Conditions

Urinary Bladder, Neurogenic

Keywords

neurogenic detrusor overactivity; fesoterodine; Japan

Outcome Measures

Primary Outcomes (42)

• Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Merged Data of Studies A0221047 and A0221109

  An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events. TEAEs were summarized for each cohort (Cohort 1 and Cohort 2, irrespective of treatment received), each treatment group and the total of treatment groups, using the merged data of studies A0221047 and A0221109 as planned.

  Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)

• Change From Baseline in Visual Acuity at Week 12: Study A0221109

  Visual acuity (VA) was assessed for each eye using the Snellen method, where logarithm of minimum angle of resolution (logMAR) units were derived from the Snellen ratios. Participants had to read letters from the chart at a distance of 20 feet/6 meter or 4 meter. VA (Snellen ratio) = distance between the chart and participant, divided by distance at which participant was able to see/read chart without impairment; expressed as decimal. logMAR = log10 (1/decimal VA). In this outcome measure, data have been reported for right and left eye separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.

  A0221109: Baseline, Week 12

• Change From Baseline in Visual Acuity at Week 28: Study A0221109

  VA was assessed for each eye using the Snellen method, where logMAR units were derived from the Snellen ratios. Participants had to read letters from the chart at a distance of 20 feet/6 meter or 4 meter. VA (Snellen ratio) = distance between the chart and participant, divided by distance at which participant was able to see/read chart without impairment; expressed as decimal. logMAR = log10 (1/decimal VA). In this outcome measure, data have been reported for right and left eye separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.

  A0221109: Baseline, Week 28

• Change From Baseline in Visual Acuity at Final Visit: Study A0221109

  VA was assessed for each eye using the Snellen method, where logMAR units were derived from the Snellen ratios. Participants had to read letters from the chart at a distance of 20 feet/6 meter or 4 meter. VA (Snellen ratio) = distance between the chart and participant, divided by distance at which participant was able to see/read chart without impairment; expressed as decimal. logMAR = log10 (1/decimal VA). In this outcome measure, data have been reported for right and left eye separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.

  A0221109: Baseline, Final visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)

• Change From Baseline in Visual Accommodation at Week 12: Study A0221109

  The visual accommodation was the minimum focusing distance for each eye at which vision became blurred - the mean of triplicate measurements. The participants focused on a single letter of the 20/40 line of an eye chart and chart was moved slowly towards the participant until letter was blurred. At this point, the distance from eye to letter was measured for each eye. In this outcome measure data have been reported for right and left eye separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.

  A0221109: Baseline, Week 12

• Change From Baseline in Visual Accommodation at Week 28: Study A0221109

  The visual accommodation was the minimum focusing distance for each eye at which vision became blurred - the mean of triplicate measurements. The participants focused on a single letter of the 20/40 line of an eye chart and chart was moved slowly towards the participant until letter was blurred. At this point, the distance from eye to letter was measured for each eye. In this outcome measure data have been reported for right and left eye separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.

  A0221109: Baseline, Week 28

• Change From Baseline in Visual Accommodation at Final Visit: Study A0221109

  The visual accommodation was the minimum focusing distance for each eye at which vision became blurred - the mean of triplicate measurements. The participants focused on a single letter of the 20/40 line of an eye chart and chart was moved slowly towards the participant until letter was blurred. At this point, the distance from eye to letter was measured for each eye. In this outcome measure data have been reported for right and left eye separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.

  A0221109: Baseline, Final visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)

• Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 12: Study A0221109

  CBCL: assessed child's behavioral and emotional problems. Parent/caregiver of child answered 120 items, each on scale: 0=not true, 1=somewhat/sometimes true, 2=very/often true. 103 items were categorized in 8 domains: aggressive behavior, anxious/depressed, attention problems, rule-breaking behavior, social problems, somatic complaints, thought problems, withdrawn. Summary scores: Internalizing problems =anxious/depressed+withdrawn+somatic complaints; Externalizing problems =rule-breaking+aggressive behavior. Total problems =8 domains+other 17 items. Raw scores for each domain, summary and total problems =sum of scores of related items. Using ADM tool raw scores transformed/derived into standard T-scores, range: each domain=50-100, internalizing problems=34-100, externalizing problems=33-100, total problems=24-100. Lower T-score (8 domain,2 summary,total problems)=better outcomes. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.

  A0221109: Baseline, Week 12

• Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Week 28: Study A0221109

  CBCL: assessed child's behavioral and emotional problems. Parent/caregiver of child answered 120 items, each on scale: 0=not true, 1=somewhat/sometimes true, 2=very/often true. 103 items were categorized in 8 domains: aggressive behavior, anxious/depressed, attention problems, rule-breaking behavior, social problems, somatic complaints, thought problems, withdrawn. Summary scores: Internalizing problems =anxious/depressed+withdrawn+somatic complaints; Externalizing problems =rule-breaking+aggressive behavior. Total problems =8 domains+other 17 items. Raw scores for each domain, summary and total problems =sum of scores of related items. Using ADM tool raw scores transformed/derived into standard T-scores, range: each domain=50-100, internalizing problems=34-100, externalizing problems=33-100, total problems=24-100. Lower T-score (8 domain,2 summary,total problems)=better outcomes. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.

  A0221109: Baseline, Week 28

• Change From Baseline in Child Behavior Checklist (CBCL) T Score (Derived Score) at Final Visit: Study A0221109

  CBCL: assessed child's behavioral and emotional problems. Parent/caregiver of child answered 120 items, each on scale: 0=not true, 1=somewhat/sometimes true, 2=very/often true. 103 items were categorized in 8 domains: aggressive behavior, anxious/depressed, attention problems, rule-breaking behavior, social problems, somatic complaints, thought problems, withdrawn. Summary scores: Internalizing problems =anxious/depressed+withdrawn+somatic complaints; Externalizing problems =rule-breaking+aggressive behavior. Total problems =8 domains+other 17 items. Raw scores for each domain, summary and total problems =sum of scores of related items. Using ADM tool raw scores transformed/derived into standard T-scores, range: each domain=50-100, internalizing problems=34-100, externalizing problems=33-100, total problems=24-100. Lower T-score (8 domain,2 summary,total problems)=better outcomes. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.

  A0221109: Baseline, Final visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)

• Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Week 12: Study A0221109

  CBCL:assessed child's behavioral and emotional problems. Parent/caregiver of child answered 120 items, each on scale:0=not true, 1=somewhat/sometimes true, 2=very/often true. 103 items were classified in 8 domains: aggressive behavior, total score range (TSR) =0-36; anxious/depressed,TSR=0-26; attention problems,TSR=0-20; rule-breaking behavior, TSR=0-34; social problems, TSR=0-22; somatic complaints, TSR=0-22; thought problems, TSR=0-30; withdrawn, TSR=0-16. Summary scores: externalizing problems combined rule-breaking and aggressive behavior,TSR=0-70; internalizing problems combined anxious/depressed, withdrawn and somatic complaints, TSR=0-64. Total problems combined 8 domains and 17 remaining items,TSR=0-240. TSR for each domain, summary and total problems was sum of scores of related items respectively. Lower scores for each domain, summary, total problems = better outcomes.Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.

  A0221109: Baseline, Week 12

• Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Week 28: Study A0221109

  CBCL:assessed child's behavioral and emotional problems. Parent/caregiver of child answered 120 items, each on scale:0=not true, 1=somewhat/sometimes true, 2=very/often true. 103 items were classified in 8 domains: aggressive behavior, total score range (TSR) =0-36; anxious/depressed,TSR=0-26; attention problems,TSR=0-20; rule-breaking behavior, TSR=0-34; social problems, TSR=0-22; somatic complaints, TSR=0-22; thought problems, TSR=0-30; withdrawn, TSR=0-16. Summary scores: externalizing problems combined rule-breaking and aggressive behavior,TSR=0-70; internalizing problems combined anxious/depressed, withdrawn and somatic complaints, TSR=0-64. Total problems combined 8 domains and 17 remaining items,TSR=0-240. TSR for each domain, summary and total problems was sum of scores of related items respectively. Lower scores for each domain, summary, total problems = better outcomes.Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.

  A0221109: Baseline, Week 28

• Change From Baseline in Child Behavior Checklist (CBCL) Total Score (Raw Score) at Final Visit: Study A0221109

  CBCL:assessed child's behavioral and emotional problems. Parent/caregiver of child answered 120 items, each on scale:0=not true, 1=somewhat/sometimes true, 2=very/often true. 103 items were classified in 8 domains: aggressive behavior, total score range (TSR) =0-36; anxious/depressed,TSR=0-26; attention problems,TSR=0-20; rule-breaking behavior, TSR=0-34; social problems, TSR=0-22; somatic complaints, TSR=0-22; thought problems, TSR=0-30; withdrawn, TSR=0-16. Summary scores: externalizing problems combined rule-breaking and aggressive behavior,TSR=0-70; internalizing problems combined anxious/depressed, withdrawn and somatic complaints, TSR=0-64. Total problems combined 8 domains and 17 remaining items,TSR=0-240. TSR for each domain, summary and total problems was sum of scores of related items respectively. Lower scores for each domain, summary, total problems = better outcomes.Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.

  A0221109: Baseline, Final visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)

• Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 12- Time to Completion: Study A0221109

  The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Participants were asked to insert 10 grooved pegs into holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Time taken to complete the test was inversely correlated to the cognitive ability. Participants were assigned to either a 10 or 25-peg assessment based on their age. 10-peg assessment was done on participants below age of 9 years. In this outcome measure data for dominant and non-dominant hand have been reported separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.

  A0221109: Baseline, Week 12

• Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 28- Time to Completion: Study A0221109

  The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Participants were asked to insert 10 grooved pegs into holes within the given time limit (up to 300 seconds). The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Time taken to complete the test was inversely correlated to the cognitive ability. Participants were assigned to either a 10 or 25-peg assessment based on their age. 10-peg assessment was done on participants below age of 9 years. In this outcome measure data for dominant and non-dominant hand have been reported separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.

  A0221109: Baseline, Week 28

• Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Final Visit- Time to Completion: Study A0221109

  The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Participants were asked to insert 10 grooved pegs into holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Time taken to complete the test was inversely correlated to the cognitive ability. Participants were assigned to either a 10 or 25-peg assessment based on their age. 10-peg assessment was done on participants below age of 9 years. In this outcome measure data for dominant and non-dominant hand have been reported separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.

  A0221109: Baseline, Final visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)

• Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 12- Time to Completion: Study A0221109

  The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Participants were asked to insert 25 grooved pegs into holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Time taken to complete the test was inversely correlated to the cognitive ability. Participants were assigned to either a 10 or 25-peg assessment based on their age. 25-peg assessment was done on participants of age 9 years and above. In this outcome measure data for dominant and non-dominant hand have been reported separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.

  A0221109: Baseline, Week 12

• Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 28- Time to Completion: Study A0221109

  The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Participants were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Time taken to complete the test was inversely correlated to the cognitive ability. Participants were assigned to either a 10 or 25-peg assessment based on their age. 25-peg assessment was done on participants of age 9 years and above. In this outcome measure data for dominant and non-dominant hand have been reported separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.

  A0221109: Baseline, Week 28

• Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Final Visit- Time to Completion: Study A0221109

  The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Participants were asked to insert 25 grooved pegs into the holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Time taken to complete the test was inversely correlated to the cognitive ability. Participants were assigned to either a 10 or 25-peg assessment based on their age. 25-peg assessment was done on participants of age 9 years and above. In this outcome measure data for dominant and non-dominant hand have been reported separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.

  A0221109: Baseline, Final visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)

• Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 12- Number of Pegs Dropped: Study A0221109

  The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Participants were asked to insert 10 grooved pegs into the holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs dropped while putting in the holes were measured. Participants were assigned to either a 10 or 25-peg assessment based on their age. 10-peg assessment was done on participants below age of 9 years. In this outcome measure data for dominant and non-dominant hand have been reported separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.

  A0221109: Baseline, Week 12

• Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 28- Number of Pegs Dropped: Study A0221109

  The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Participants were asked to insert 10 grooved pegs into the holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs dropped while putting in the holes were measured. Participants were assigned to either a 10 or 25-peg assessment based on their age. 10-peg assessment was done on participants below age of 9 years. In this outcome measure data for dominant and non-dominant hand have been reported separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.

  A0221109: Baseline, Week 28

• Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Final Visit- Number of Pegs Dropped: Study A0221109

  The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Participants were asked to insert 10 grooved pegs into the holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs dropped while putting in the holes were measured. Participants were assigned to either a 10 or 25-peg assessment based on their age. 10-peg assessment was done on participants below age of 9 years. In this outcome measure data for dominant and non-dominant hand have been reported separately. Data for this outcome measure was planned to be analyzed for each treatment group of Study A0221109 only.

  A0221109: Baseline, final visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)

• Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 12- Number of Pegs Dropped: Study A0221109

  The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Participants were asked to insert 25 grooved pegs into the holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs dropped while putting in the holes were measured. Participants were assigned to either a 10 or 25-peg assessment based on their age. 25-peg assessment was done on participants of age 9 years and above. In this outcome measure data for dominant and non-dominant hand have been reported separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.

  A0221109: Baseline, Week 12

• Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 28- Number of Pegs Dropped: Study A0221109

  The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Participants were asked to insert 25 grooved pegs into the holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs dropped while putting in the holes were measured. Participants were assigned to either a 10 or 25-peg assessment based on their age. 25-peg assessment was done on participants of age 9 years and above. In this outcome measure data for dominant and non-dominant hand have been reported separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.

  A0221109: Baseline, Week 28

• Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Final Visit- Number of Pegs Dropped: Study A0221109

  The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Participants were asked to insert 25 grooved pegs into the holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs dropped while putting in the holes were measured. Participants were assigned to either a 10- or 25-peg assessment based on their age. 25-peg assessment was done on participants of age 9 years and above. In this outcome measure data for dominant and non-dominant hand have been reported separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.

  A0221109: Baseline, Final visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)

• Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 12- Number of Pegs Placed Correctly: Study A0221109

  The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Participants were asked to insert 10 grooved pegs into the holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs placed correctly in hole was measured. Participants were assigned to either a 10 or 25-peg assessment based on their age. 10-peg assessment was done on participants below age of 9 years. In this outcome measure data for dominant and non-dominant hand have been reported separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.

  A0221109: Baseline, Week 12

• Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Week 28- Number of Pegs Placed Correctly: Study A0221109

  The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Participants were asked to insert 10 grooved pegs into the holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs placed correctly in hole was measured. Participants were assigned to either a 10 or 25-peg assessment based on their age. 10-peg assessment was done on participants below age of 9 years. In this outcome measure data for dominant and non-dominant hand have been reported separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.

  A0221109: Baseline, Week 28

• Change From Baseline in Grooved Pegboard Test (10 Pegs Group) at Final Visit- Number of Pegs Placed Correctly: Study A0221109

  The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Participants were asked to insert 10 grooved pegs into the holes within the given time limit (up to 300 seconds). The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs placed correctly in hole was measured. Participants were assigned to either a 10 or 25-peg assessment based on their age. 10-peg assessment was done on participants below age of 9 years. In this outcome measure data for dominant and non-dominant hand have been reported separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.

  A0221109: Baseline, Final visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)

• Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 12- Number of Pegs Placed Correctly: Study A0221109

  The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Participants were asked to insert 25 grooved pegs into the holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs placed correctly in hole was measured. Participants were assigned to either a 10 or 25-peg assessment based on their age. 25-peg assessment was done on participants of age 9 years and above. In this outcome measure data for dominant and non-dominant hand have been reported separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.

  A0221109: Baseline, Week 12

• Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Week 28- Number of Pegs Placed Correctly: Study A0221109

  The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Participants were asked to insert 25 grooved pegs into the holes within the given time limit (up to 300 seconds). The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs placed correctly in hole was measured. Participants were assigned to either a 10 or 25-peg assessment based on their age. 25-peg assessment was done on participants of age 9 years and above. In this outcome measure data for dominant and non-dominant hand have been reported separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.

  A0221109: Baseline, Week 28

• Change From Baseline in Grooved Pegboard Test (25 Pegs Group) at Final Visit- Number of Pegs Placed Correctly: Study A0221109

  The grooved pegboard test was a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. Participants were asked to insert 25 grooved pegs into the holes within the given time limit up to 300 seconds. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. Number of pegs placed correctly in hole was measured. Participants were assigned to either a 10 or 25-peg assessment based on their age. 25-peg assessment was done on participants of age 9 years and above. In this outcome measure data for dominant and non-dominant hand have been reported separately. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.

  A0221109: Baseline, Final visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)

• Change From Baseline in Vital Sign (Blood Pressure) at Week 12: Study A0221109

  Systolic and diastolic blood pressure were evaluated for examination of vital signs. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.

  A0221109: Baseline, Week 12

• Change From Baseline in Vital Sign (Blood Pressure) at Week 28: Study A0221109

  Systolic and diastolic blood pressure were evaluated for examination of vital signs. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.

  A0221109: Baseline, Week 28

• Change From Baseline in Vital Sign (Blood Pressure) at Final Visit: Study A0221109

  Systolic and diastolic blood pressure were evaluated for examination of vital signs. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.

  A0221109: Baseline, Final visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)

• Change From Baseline in Vital Sign (Pulse Rate) at Week 12: Study A0221109

  Pulse rate was evaluated for examination of vital signs. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.

  A0221109: Baseline, Week 12

• Change From Baseline in Vital Sign (Pulse Rate) at Week 28: Study A0221109

  Pulse rate was evaluated for examination of vital signs. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.

  A0221109: Baseline, Week 28

• Change From Baseline in Vital Sign (Pulse Rate) at Final Visit: Study A0221109

  Pulse rate was evaluated for examination of vital signs. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.

  A0221109: Baseline, Final visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)

• Number of Participants With Adverse Event Urinary Tract Infections (UTI): Merged Data of Studies A0221047 and A0221109

  UTI data were summarized for each cohort, each treatment group and the total of treatment groups, using the merged data of studies A0221047 and A0221109 as planned.

  Up to a maximum of 56 weeks (24 weeks of treatment in A0221047 and 32 weeks [28 weeks treatment + 4 weeks follow up post last dose] in A0221109)

• Number of Participants With Clinical Laboratory Abnormalities

  Hematology: hemoglobin, hematocrit, erythrocytes \<0.8\*lower limit of normal (LLN); platelets\<0.5\*LLN\>1.75\*upper limit of normal (ULN); leukocytes \<0.6\*LLN\>1.5\*ULN; lymphocytes, neutrophils \<0.8\*LLN \>1.2\*UL; basophils, eosinophils, monocytes \>1.2\*ULN. Clinical chemistry: bilirubin, direct bilirubin \>1.5\*ULN; aspartate aminotransferase (AT), alanine AT, gamma glutamyl transferase, lactate dehydrogenase, alkaline phosphatase \>3.0\*ULN; protein, albumin \<0.8\*LLN \>1.2\*ULN; blood urea nitrogen, creatinine \>1.3\*ULN; urate \>1.2\*ULN, sodium\<0.95\*LLN\>1.05\*ULN; potassium, chloride, bicarbonate \<0.9\*LLN\>1.1\*ULN; glucose \<0.6\*LLN\>1.5\*ULN; creatine kinase \>2.0\*ULN. Urinalysis: specific gravity \<1.003\>1.030, pH \<4.5\>8, glucose, ketones, protein, hemoglobin, nitrite, leukocyte esterase \>=1; erythrocytes, leukocytes \>=20; epithelial cells \>=6, bacteria \>20, hyaline casts \>1. Data for this outcome was planned to be analysed for each treatment group of study A0221109 only.

  A0221109: Baseline to 28 weeks

• Change From Baseline in Post-Void Residual (PVR) Volume at Week 12: Study A0221109

  Post-void residual volume was assessed by an ultrasound. PVR volume was assessed only in participants who did not perform clean intermittent catheterization or in any participants who had \>1 UTI during the study. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.

  A0221109: Baseline, Week 12

• Change From Baseline in Post-Void Residual (PVR) Volume at Week 28: Study A0221109

  Post-void residual volume measurement was measured by an ultrasound. PVR volume was only assessed for participants who did not perform clean intermittent catheterization or in any participants who had \>1 UTI during the study. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.

  A0221109: Baseline, Week 28

• Change From Baseline in Post-Void Residual (PVR) Volume at Final Visit: Study A0221109

  Post-void residual volume measurement was measured by an ultrasound. PVR volume was only assessed for participants who did not perform clean intermittent catheterization or in any participants who had \>1 UTI during the study. Data for this outcome measure was planned to be analyzed for each treatment group of study A0221109 only.

  A0221109: Baseline, final visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)

Secondary Outcomes (13)

• Change From Baseline in Maximum Cystometric Bladder Capacity at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109

  Study A0221047: Baseline, Week 12; Study A0221109: Week 28, Final Visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)

• Change From Baseline in Detrusor Pressure at Maximum Bladder Capacity at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109

  Study A0221047: Baseline, Week 12; Study A0221109: Week 28, Final Visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)

• Number of Participants With Presence of Involuntary Detrusor Contraction (IDC) at Baseline and Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109

  Study A0221047: Baseline, Week 12; Study A0221109: Week 28, Final Visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)

• Change From Baseline in Bladder Volume at First Involuntary Detrusor Contraction (IDC) at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109

  Study A0221047: Baseline, Week 12; Study A0221109: Week 28, Final Visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)

• Change From Baseline in Bladder Compliance at Week 12 of Study A0221047 and at Week 28 and Final Visit of Study A0221109

  Study A0221047: Baseline, Week 12; Study A0221109: Week 28, Final Visit (Week 28 for participants who completed the study or in case of early withdrawal the last assessment before Week 28 was considered to be the final visit)

Study Arms (4)

Fesoterodine PR 4 mg

EXPERIMENTAL

Fesoterodine PR 4 mg for 28 or 40 weeks in open-label treatment period

Drug: Fesoterodine PR 4 mg

Fesoterodine PR 8 mg

EXPERIMENTAL

Fesoterodine PR 8 mg for 28 or 40 weeks in open-label treatment period

Drug: Fesoterodine PR 8 mg

Fesoterodine BIC 2 mg

EXPERIMENTAL

Fesoterodine BIC 2 mg for 28 weeks in open-label treatment period

Drug: Fesoterodine BIC 2 mg

Fesoterodine BIC 4 mg

EXPERIMENTAL

Fesoterodine BIC 4 mg for 28 weeks in open-label treatment period

Drug: Fesoterodine BIC 4 mg

Interventions

Fesoterodine PR 4 mg DRUG

Fesoterodine 4 mg tablet once daily for 28 or 40 weeks

Fesoterodine PR 4 mg

Fesoterodine PR 8 mg DRUG

Fesoterodine PR 8 mg tablet once daily for 28 or 40 weeks

Fesoterodine PR 8 mg

Fesoterodine BIC 2 mg DRUG

Fesoterodine BIC 2 mg tablet once daily for 28 weeks

Fesoterodine BIC 2 mg

Fesoterodine BIC 4 mg DRUG

Fesoterodine BIC 4 mg tablet once daily for 28 weeks

Fesoterodine BIC 4 mg

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Subjects who completed 24 week treatment and all visit procedures in the precedent Study A0221047

You may not qualify if:

• Subjects who had major protocol violation (as determined by the Sponsor) in Study A0221047
• Concomitant medications which may increase the risk to subjects or confound study results
• Other medical conditions which may increase the risk to subjects or confound study results

Sponsors & Collaborators

• Pfizer: lead

Study Sites (7)

Aichi Children's Health and Medical Center

Ōbu, Aichi-ken, 474-8710, Japan

Location

Chiba Children's Hospital

Midori-ku Chiba-shi, Chiba, 266-0007, Japan

Location

Fukuoka Children's Hospital

Fukuoka, Fukuoka, 813-0017, Japan

Location

Kanagawa Children's Medical Center

Yokohama, Kanagawa, 232-8555, Japan

Location

Osaka Women's and Children's Hospital

Izumi-shi, Osaka, 594-1101, Japan

Location

Shizuoka Children's Hospital

Aoi-ku Shizuoka-shi, Shizuoka, 420-8660, Japan

Location

Dokkyo Medical University Hospital

Shimotsuga-gun, Tochigi, 321-0293, Japan

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Urinary Bladder, Neurogenic

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Prioritization of outcome measures was based on study team's discretion.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2015
• First Posted: July 17, 2015
• Study Start: June 5, 2015
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: November 30, 2020
• Results First Posted: October 26, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share

Locations

JP (7)