A Clinical Study to Investigate How Solifenacin Fluid is Taken up, How Long it Stays in the Body and How Effective and Safe it is in Treating Children Aged From 6 Months to Less Than 5 Years With Symptoms of Neurogenic Detrusor Overactivity (NDO)

NCT01981954 | Completed Phase 3 Results DMC

• 2 other identifiers: 905-CL-0742012-003178-22
• Study Type: interventional
• Target: 23
• Locations: 6 countries
• Sites: 8

Brief Summary

The purpose of this study was to evaluate long term efficacy and safety of treatment with solifenacin succinate (the study drug) in children with neurogenic detrusor overactivity after multiple dose administration.

Conditions

Neurogenic Detrusor Overactivity; Pediatric

Keywords

Solifenacin succinate suspension; Efficacy; Safety

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 24 in Maximum Cystometric Capacity (MCC)

  MCC was the volume instilled into the bladder prior to leakage or end of bladder-filling (whichever was reached first), as assessed by urodynamics (procedure: the bladder was to be filled until voiding/leakage began, or until it was stopped because either the participant experienced pain or discomfort or 135% of expected bladder capacity \[EBC\] was reached for participants ≥ 2 years or of maximum catheterized volume \[MCV\] for participants aged 6 months to \< 2 years; the participants' bladder was emptied via catheterization).

  Baseline and Week 24

Secondary Outcomes (41)

• Change From Baseline to Weeks 3, 6, 9, 12 and 52 in MCC

  Baseline and Weeks 3, 6, 9, 12, 52

• Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Compliance

  Baseline and Weeks 3, 6, 9, 12, 24, 52

• Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Detrusor Pressure at End of Bladder-Filling

  Baseline and Weeks 3, 6, 9, 12, 24, 52

• Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Detrusor Pressure 5 Minutes After End of Bladder-Filling

  Baseline and Weeks 3, 6, 9, 12, 24, 52

• Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Catheterized Volume 5 Minutes After End of Bladder-Filling

  Baseline and Weeks 3, 6, 9, 12, 24, 52

Study Arms (1)

Solifenacin succinate

EXPERIMENTAL

Children aged 6 months to less than 5 years were treated with sequential titrated doses of solifenacin up to 12 weeks in the Titration period after which a fixed dose of solifenacin was given for at least 40 weeks in the Fixed-dose assessment period. Children received solifenacin once daily during these 2 periods.

Drug: Solifenacin succinate

Interventions

Solifenacin succinate DRUG

Oral suspension

Also known as: solifenacin, YM905, solifenacin succinate suspension

Solifenacin succinate

Eligibility Criteria

• Age: 6 Months - 4 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Myelomeningocoele
• Documented diagnosis of NDO, confirmed by urodynamics
• DSD (detrusor sphincter dyssynergia)
• Practicing clean intermittent catheterization (CIC)

You may not qualify if:

• Know genitourinary condition (other than NDO) that may cause incontinence
• Bladder augmentation surgery
• Current faecal impaction
• Electro-stimulation therapy within 2 weeks prior to visit
• Subjects with the following gastro-intestinal problems: partial or complete obstructions, decreased motility like paralytic ileus, subjects at risk of gastric retention
• Reflux grade 3 to 5
• Current urinary tract infection

Sponsors & Collaborators

• Astellas Pharma Europe B.V.: lead

Study Sites (8)

Site US1008 Pediatric Urology Associates, P.C.

Tarrytown, New York, 10591, United States

Location

Site BE3203 Gent University Hospital

Ghent, 9000, Belgium

Location

Site PH6301 Philippines Children's Medical Center

Manila, 1015, Philippines

Location

Site PL4803 Uniwersyteckie Centrum Kliniczne

Gdansk, 81-211, Poland

Location

Site PL4801 Pomnik-Centrum Zdrowia Dziecka

Warsaw, 04-730, Poland

Location

Site KR8207 Seoul National University Hospital

Seoul, 110744, South Korea

Location

Site KR8201 Severance Hospital

Seoul, 120752, South Korea

Location

Site GB4401 Sheffield Children's Hospital

Sheffield, S10 2TN, United Kingdom

Location

Related Publications (2)

• Tannenbaum S, den Adel M, Krauwinkel W, Meijer J, Hollestein-Havelaar A, Verheggen F, Newgreen D. Pharmacokinetics of solifenacin in pediatric populations with overactive bladder or neurogenic detrusor overactivity. Pharmacol Res Perspect. 2020 Dec;8(6):e00684. doi: 10.1002/prp2.684.

  PMID: 33231929 DERIVED

• Franco I, Hoebeke P, Baka-Ostrowska M, Bolong D, Davies LN, Dahler E, Snijder R, Stroosma O, Verheggen F, Newgreen D, Bosman B, Vande Walle J. Long-term efficacy and safety of solifenacin in pediatric patients aged 6 months to 18 years with neurogenic detrusor overactivity: results from two phase 3 prospective open-label studies. J Pediatr Urol. 2020 Apr;16(2):180.e1-180.e8. doi: 10.1016/j.jpurol.2019.12.012. Epub 2019 Dec 27.

  PMID: 32007426 DERIVED

Related Links

• Link to results on the Astellas Clinical Study Results website

MeSH Terms

Interventions

Solifenacin Succinate

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Medical Director
• Organization: Astellas Pharma Europe B.V.

astellas.resultsdisclosure@astellas.com

+31 (0) 715455050

Study Officials

• Medical Director

  Astellas Pharma Europe B.V.

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2013
• First Posted: November 13, 2013
• Study Start: September 25, 2013
• Primary Completion: December 18, 2015
• Study Completion: December 18, 2015
• Last Updated: October 31, 2024
• Results First Posted: June 21, 2018

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2); PL (2); US (1); BE (1); PH (1); GB (1)