CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 356 enrolled
Drug / intervention
BOTOX® +3 morebiological
Likely dose
solifenacin 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01767519
NCT01767519Phase 3Completed
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A Study Evaluating the Efficacy and Safety of BOTOX® or Solifenacin in Patients With Overactive Bladder and Urinary Incontinence

Allergan·interventional·Posted Jan 14, 2013·Updated Apr 23, 2019

In Brief

A Phase 3 clinical trial evaluating BOTOX®, solifenacin, and 2 other interventions for Overactive Bladder and Urinary Incontinence. Completed, enrolled 356 participants across 8 sites in 7 countries.

Detailed Summary

A study to evaluate the efficacy and safety of BOTOX® or Solifenacin in patients with overactive bladder (OAB) and urinary incontinence.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOveractive Bladder, Urinary Incontinence
CountriesBelgium, Canada, Czechia, Germany, Poland, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 14, 2013
Enrollment StartMar 1, 2013
Primary CompletionSep 30, 2014
Study CompletionMar 18, 2015
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 13.5 years ago

Interventions

BOTOX®biological

BOTOX 100U injected at Day 1 (BOTOX/solifenacin placebo arm). After a minimum of 12 weeks, all patients could request/qualify for a BOTOX injection.

solifenacindrug

Beginning on Day 1, one 5 mg solifenicin capsule, with optional dose increase to 10 mg at Week 6, (both overencapsulated for blinding purposes) taken orally once daily for up to 24 weeks.

Botox placebo (normal saline)drug

Botox placebo (normal saline) intradetrusor injection at Day 1.

solifenacin placebodrug

Beginning on Day 1, one capsule taken orally once daily for up to 24 weeks.