A study to investigate how safe and effective solifenacin fluid is in treating children/adolescents with symptoms of overactive bladder (OAB) who completed study 905-CL-076 (LEOPARD)

PHRR121119-000018

Protocol No. 905-CL-077, ClinicalTrials.gov Identifier: NCT01655069, EudraCT2011-002047-10

2012-CT0020

An Open-Label, Long-Term Extension, Multi-center, Sequential Dose Titration Study to Assess Safety and Efficacy of Solifenacin Succinate Suspension in Pediatric Subjects with Overactive Bladder (OAB)

This is a 40-week study to investigate how safe and effective solifenacin solution is in treating children/adolescents with symptoms of overactive bladder (OAB) who completed study 905-CL-076. To measure the efficacy of the treatment the patient will complete a 7-day patient diary prior to every visit, starting at Visit 9. The patient will attend the study clinic on 7 separate occasions. The first visit of this study (905-CL-077) will be combined with the last visit of the 4-month study 905-CL-076. At each visit, the patient will be required to undertake a number of assessments or examinations to determine whether it is safe for him/her to take part or to continue to take part in the study. During the first 3 visits the dosage of the study drug will be adjusted if needed in order to optimize the most effective and safe dose for each patient.

Regime Classification Priority
2010 - 2016 Health Technology Development Drug Discovery and Development
Start Date Duration in Months Target Completion Date Actual Completion Date
2012-09-03 20 2014-05-03 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
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

Incidence and severity of adverse events [ Time Frame: Week 12 to Week 52 (End of study) ]

• Change from baseline of study 905-CL-076 to end of this study in efficacy measured by mean number of daytime incontinence episodes/24 hours [ Time Frame: Baseline and Week 52 ] • Change from baseline of study 905-CL-076 to end of this study in efficacy measured by mean number of nighttime incontinence episodes/24 hours [ Time Frame: Baseline and Week 52 ] • Change from baseline of study 905-CL-076 to end of this study in efficacy measured by number of dry (incontinence-free) days/7 days [ Time Frame: Baseline and Week 52 ] • Change from baseline of study 905-CL-076 to end of this study in efficacy measured by mean number of daytime micturitions/24 hours [ Time Frame: Baseline and Week 52 ] • Change from baseline of study 905-CL-076 to end of this study in efficacy measured by mean number of grade 3 or 4 urgency episodes per 24 hours in adolescents [ Time Frame: Baseline and Week 52 ] • Safety as assessed by recording laboratory tests, vital signs, urinalysis, PVR (post void residual) volume and electrocardiograms (ECGs) [ Time Frame: Week 52 ]

Recruiting

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

Protocol No. 905-CL-077, ClinicalTrials.gov Identifier: NCT01655069, EudraCT2011-002047-10

Unspecified

Unspecified

0000-00-00

Protocol Code Number Protocol No. 905-CL-077, ClinicalTrials.gov Identifier: NCT01655069, EudraCT2011-002047-10
Protocol Version Unspecified
Date of Protocol Version Unspecified

15

Unspecified

N/A

Unspecified

03 Sep 2012

Inclusion Criteria: •Subject has met the inclusion criteria of study 905-CL-076 and completed study 905-CL-076

Interventional

Solifenacin Succinate Oral Suspension

Solifenacin Succinate Oral Suspension

None

Method of Allocation

Randomized

Masking or Blinding

Open-label

Masking Details

Unspecified

Control

Unspecified

Assignment

Single Arm

Phase

Phase III

Purpose of the Study

-Incidence and severity of adverse events [ Time Frame: Week 12 to Week 52 (End of study) ] • Change from baseline of study 905-CL-076 to end of this study in efficacy measured by mean number of daytime incontinence episodes/24 hours [ Time Frame: Baseline and Week 52 ] • Change from baseline of study 905-CL-076 to end of this study in efficacy measured by mean number of nighttime incontinence episodes/24 hours [ Time Frame: Baseline and Week 52 ] • Change from baseline of study 905-CL-076 to end of this study in efficacy measured by number of dry (incontinence-free) days/7 days [ Time Frame: Baseline and Week 52 ] • Change from baseline of study 905-CL-076 to end of this study in efficacy measured by mean number of daytime micturitions/24 hours [ Time Frame: Baseline and Week 52 ] • Change from baseline of study 905-CL-076 to end of this study in efficacy measured by mean number of grade 3 or 4 urgency episodes per 24 hours in adolescents [ Time Frame: Baseline and Week 52 ] • Safety as assessed by recording laboratory tests, vital signs, urinalysis, PVR (post void residual) volume and electrocardiograms (ECGs) [ Time Frame: Week 52 ]

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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