A Study to Investigate How Effective and Safe Solifenacin Liquid Suspension is in Treating Children/Adolescents Aged 5 to Less Than 18 Years With Symptoms of Overactive Bladder (OAB) Compared to a Non-active Drug (LION)

PHRR121119-000017

Protocol No. 905-CL-076, ClinicalTrials.gov Identifier: NCT01565707, EUDRACT2011-002066-20

2012-CT0019

A Phase 3, Double-Blind, Randomized, Multi-center, Placebo-Controlled Sequential Dose Titration Study to Assess Efficacy, Safety and Population Pharmacokinetics of Solifenacin Succinate Suspension in Pediatric Subjects from 5 to less than 18 years of Age with Overactive Bladder (OAB)

Solifenacin succinate as a tablet formulation is already on the market for the treatment of symptoms of overactive bladder in adults. For the use in children and adolescent patients a new formulation of solifenacin has been developed. This study will investigate the effect and safety of solifenacin suspension compared to a non-active drug (placebo) over a 14-week period of daily treatment. The study will also investigate how well solifenacin suspension is taken-up by the body and how long it stays in the body during this time.

Regime Classification Priority
2010 - 2016 Health Technology Development Drug Discovery and Development
Start Date Duration in Months Target Completion Date Actual Completion Date
2012-06-01 18 2013-12-01 0000-00-00

Ongoing

Institution Classification Region LTO #
PPD Development (S) PTE. LTD. Private Business NCR
Institution Classification Region LTO #
Astellas Pharma Europe B.V. Private Business Netherlands
Institution Region
Astellas Pharma Europe B.V. Netherlands
Name E-Mail Institution and Institution Address
Fridee-May Ortega Fridee-May.Ortega@ppdi.com 9/F Sun Life Centre 5th Avenue corner Rizal Drive Bonifacio Global City, Taguig
Name E-Mail Institution and Institution Address
Dr. David Bolong davebolong@gmail.com Philippine Children's Medical Center, Quezon City
Name Expertise Affiliation
David Bolong, MD Urologist Philippine Children's Medical Center
Name of Trial Site Address Principal Investigator Research Ethics Committee
NAME EXPERTISE REC Name Status of Approval
Philippine Children's Medical Center Philippine Children's Medical Center, Quezon City David Bolong, MD Urologist
Project Location Institutional Ethics Review Board
Philippine Children's Medical Center Philippine Children's Medical Center IRB - Ethics Committee

Clinical Trial

Unspecified

Overactive Bladder

Change from baseline to EoT (final visit) in mean volume voided per micturition [ Time Frame: Baseline and Week 12 ] The mean voided volume will be determined using the patient diary data of two days (e.g., during the weekend).

Change from baseline to EoT (final visit) in OAB symptoms [ Time Frame: Baseline and Week 12 ] o Maximum volume voided per micturition. o Mean number of daytime incontinence episodes/24 h. o Mean number of nighttime incontinence episodes/24 h. o Mean number of incontinence episodes/24 h. o Number of dry (incontinence-free) days/7 days. o Mean number of daytime micturitions/24 h. o Mean number of micturitions/24h. o Mean number of grade 3 or 4 urgency episodes per 24 h in adolescents. Safety as assessed by recording adverse events, laboratory assessments, vital signs and electrocardiograms (ECGs) [ Time Frame: Baseline and Week 12 ]

Recruiting

  • Belgium
  • Brazil
  • Canada
  • Denmark
  • France
  • Germany
  • India
  • Italy
  • Mexico
  • Netherlands
  • Norway
  • Philippines
  • Poland
  • Russia
  • Serbia and Montenegro
  • South Africa
  • South Korea
  • Sweden
  • Turkey
  • United Kingdom

Protocol No. 905-CL-076, ClinicalTrials.gov Identifier: NCT01565707, EUDRACT2011-002066-20

Unspecified

Unspecified

0000-00-00

Protocol Code Number Protocol No. 905-CL-076, ClinicalTrials.gov Identifier: NCT01565707, EUDRACT2011-002066-20
Protocol Version Unspecified
Date of Protocol Version Unspecified

15

Unspecified

N/A

Unspecified

01 Jun 2012

Inclusion: • OAB (symptoms of urgency) according to International Children's Continence Society (ICCS) criteria • Daytime incontinence with at least 4 or more episodes of incontinence Exclusion: • Daily voiding frequency less than 5 • Uroflow indicative of pathology other than OAB • Maximum voided volume (morning volume excluded) > expected bladder capacity for age [(age +1) x 30] in ml or a maximum voided volume (morning volume excluded) above 390 ml • Post Void Residual (PVR) > 20 ml • Monosymptomatic enuresis • Congenital anomalies affecting lower urinary tract function • Current constipation • Current UTI

Interventional

Solifenacin Succinate Oral Suspension

Parallel assignment to solifenacin succinate oral suspension or placebo

None

Method of Allocation

Randomized

Masking or Blinding

Double-blind

Masking Details

Unspecified

Control

Unspecified

Assignment

Parallel

Phase

Phase III

Purpose of the Study

Change from baseline to EoT (final visit) in mean volume voided per micturition [ Time Frame: Baseline and Week 12 ] The mean voided volume will be determined using the patient diary data of two days (e.g., during the weekend). Change from baseline to EoT (final visit) in OAB symptoms [ Time Frame: Baseline and Week 12 ] o Maximum volume voided per micturition. o Mean number of daytime incontinence episodes/24 h. o Mean number of nighttime incontinence episodes/24 h. o Mean number of incontinence episodes/24 h. o Number of dry (incontinence-free) days/7 days. o Mean number of daytime micturitions/24 h. o Mean number of micturitions/24h. o Mean number of grade 3 or 4 urgency episodes per 24 h in adolescents. Safety as assessed by recording adverse events, laboratory assessments, vital signs and electrocardiograms (ECGs) [ Time Frame: Baseline and Week 12 ]

Detailed purpose of the study

Unspecified

Plan to Share IPD

Unspecified

IPD Description

Unspecified

Date of posting of result summaries

Unspecified

Date of the first journal publication of results

Unspecified

URL hyperlinks related to results and publications

Unspecified

URL link to protocol files(s) with version and data

Unspecified

Baseline Characteristics

Unspecified

Participant Flow

Unspecified

Adverse Events

Unspecified

Outcome Measures

Unspecified

Brief Summary

Unspecified

Utilization Utilization Info
No records found.
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