PK/PD, Long-term Safety and Efficacy of Tamsulosin Treatment in Children With Neurogenic Bladder
An Uncontrolled, Open-label, Titration, Long-term Safety (up to 12 Months) and Efficacy Study of Tamsulosin Hydrochloride in Children With Neuropathic Bladder, With a Randomized Pharmacokinetic Sub-study Investigating Low, Medium and High Dose Ranges.
1 other identifier
interventional
143
14 countries
72
Brief Summary
Aims of this study is to characterize the pharmacokinetic/pharmacodynamic profile and evaluate the safety, efficacy and tolerability, of tamsulosin hydrochloride as treatment in children with a neuropathic bladder, over the course of 12 months of active treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2006
Typical duration for phase_2
72 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 19, 2006
CompletedFirst Posted
Study publicly available on registry
June 21, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedResults Posted
Study results publicly available
February 17, 2016
CompletedFebruary 17, 2016
January 1, 2016
3.2 years
June 19, 2006
August 10, 2015
January 20, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of LPP Responders for Group D-Denovo and Group D-527.51 Rollover
Group D-Denovo: Leak point pressure (LPP) Response at(response defined as a subject who achieves an LPP pressure \<40 cm H2O) at the end of treatment based on two confirmatory values. Group D-527.51 Rollover: Leak point pressure (LPP) Response at (response defined as a subject who achieves an LPP pressure \<40 cm H2O) last value of the treatment based on two confirmatory values. The last value on treatment included any final value prior to discontinuation of treatment, regardless of the length of treatment. Detrusor leak point pressure (LPP) recorded in cm H2O which was obtained using a standard urodynamic technique, a cystometrogram. Descriptive statistics were used to assess this endpoint. This Outcome Measure was only pre-specified for Group D-Denovo and Group D-527.51 Rollover subjects, so results of these two groups are provided.
Group D-Denovo: Week 52. Group D-527.51 Rollover: Week 1, Week 2, Week 3 and Week 4 prior to dose administration and Week9 (optional), Week 13 (additional), Week 26 (optional) and Week 52 after drug administration.
Number of LPP Responders at Each Visit Over Time (Classified by Last Value on Treatment) for Group D-527.51 Rollover.
Number of Leak point pressure (LPP) Responders at each visit (week) over time (classified by last value on treatment). Due to the early termination of the study, most of the LPP assessments were conducted within Weeks 1-9 of treatment. Summary of LPP response rates provided over time.The subjects are classified according to the treatment they were receiving at the last value on treatment. Therefore, no assumptions can be made regarding what dose they were receiving at a particular time point. LD: Low Dose, MD: Medium Dose and HD: High Dose This Outcome Measure was only pre-specified for Group D-527.51 Rollover subjects, so results of this group is provided.
Week 1 (Visit 3) , Week 2 (Visit 4) , Week 3 (Visit 5) and Week 4 (Visit 6) prior to dose administration and Week 9 (Visit 7) (optional), Week 13 (Visit 8) (additional), Week 26 (Visit 9) (optional) and Week 52 (Visit 11) after drug administration.
Secondary Outcomes (26)
Early Responders Who Maintained Their LPP Below 40 cm H2O During the Study for Group D-Denovo and Group D-527.51 Rollover
Week 1 to Week 52 (Time frame for all weeks are described study wise in the Description).
Change From Baseline in LPP for Group D-527.51 Rollover
Baseline and week 1
Percent Change From Baseline in LPP for Group D-527.51 Rollover
Baseline and Week 1
Response Defined as Stabilization or Improvement of Hydroureter Measured by Renal Ultrasound Compared to Baseline for Group D-Denovo and Group D-527.51 Rollover
Group D-Denovo: Baseline and Week 52. Group D-527.51 Rollover: Baseline, Week 26 and Week 52.
Response Defined as Stabilization or Improvement of Hydronephrosis Measured by Renal Ultrasound Compared to Baseline for Group D-Denovo and Group D-527.51 Rollover
Group D-Denovo: Baseline and Week 52. Group D-527.51 Rollover: Baseline, Week 26 and Week 52.
- +21 more secondary outcomes
Study Arms (3)
1. Low dose group
EXPERIMENTAL2. Medium dose group
EXPERIMENTAL3. High dose group
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Neuropathic bladder secondary to known neurological disorder
- Elevated detrusor leak point pressures (LPP) ≥40 cm H2O confirmed by two measurements at baseline
You may not qualify if:
- Clinically significant abnormalities as determined by the investigator
- A history of relevant orthostatic hypotension, fainting spells or blackouts
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (72)
Unknown Facility
Birmingham, Alabama, 35233, United States
Unknown Facility
Los Angeles, California, 90027, United States
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Jacksonville, Florida, 32207, United States
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Tampa, Florida, 33614, United States
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Springfield, Illinois, 62702, United States
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Indianapolis, Indiana, 46202, United States
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Shreveport, Louisiana, 71106, United States
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St Louis, Missouri, 63110, United States
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Buffalo, New York, 14222, United States
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Lake Success, New York, 11042, United States
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Tarrytown, New York, 10591, United States
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Winston-Salem, North Carolina, 27157, United States
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Akron, Ohio, 44308, United States
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Oklahoma City, Oklahoma, 73104, United States
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Nashville, Tennessee, 37232, United States
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Dallas, Texas, 75235, United States
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Houston, Texas, 77030, United States
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Salt Lake City, Utah, 84132, United States
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Madison, Wisconsin, 53792, United States
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Ghent, 9000, Belgium
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Santo André, 09060-650, Brazil
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São Paulo, 05403-000, Brazil
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Halifax, B3K 6R8, Canada
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Montreal, H3H 1P3, Canada
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Montreal, H3T 1J5, Canada
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Toronto, M5G 1X8, Canada
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Berlin, 10115, Germany
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Deggendorf, 94469, Germany
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Essen, 45122, Germany
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Hamburg, 22763, Germany
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Mainz, 55101, Germany
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Ahmedabad, 380-006, India
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Belagavi, 590-010, India
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Bengaluru, 560-010, India
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Hyderabaad, 500-029, India
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Kochi, 682-026, India
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Lucknow, 226-003, India
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Lucknow, 226-014, India
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Ludhiana, 141-001, India
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Ludhiana, 141-008, India
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Manipal, 576-104, India
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Mumbai, 400-008, India
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Nadiād, 387-001, India
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Nagpur, India
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New Delhi, 110-029, India
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Pune, 411-001, India
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Pune, 411-053, India
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Cagliari, 09134, Italy
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Florence, 50139, Italy
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Roma, 00165, Italy
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León, 37660, Mexico
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Puebla City, CP 72190, Mexico
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Manila, 1000, Philippines
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Pasig, 1604, Philippines
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Quezon City, 1104, Philippines
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Moscow, 119991, Russia
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Saint Petersburg, 194100, Russia
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Bloemfontein, 9300, South Africa
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Cape Town, 7700, South Africa
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Johannesburg, South Africa
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Pretoria, 0028, South Africa
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Roodepoort, South Africa
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Gwangju, 501-757, South Korea
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Incheon, 400-711, South Korea
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Pusan, 602-739, South Korea
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Seoul, 110-744, South Korea
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Seoul, 120-752, South Korea
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Seoul, 138-736, South Korea
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Barcelona, 08025, Spain
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Madrid, 28046, Spain
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Málaga, 29011, Spain
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Chernivtsy, 58002, Ukraine
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
In Group D-527.51 Rollover study, due to the early termination caution should be used in interpreting these results due to the impact of the early termination, as well as the impact of the study design on interpretation of results by dose.
Results Point of Contact
- Title
- Boehringer Ingelheim, Call Center
- Organization
- Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2006
First Posted
June 21, 2006
Study Start
April 1, 2006
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
February 17, 2016
Results First Posted
February 17, 2016
Record last verified: 2016-01