A RANDOMISED, MULTI-CENTRE, DOUBLE-BLIND, PLACEBO- AND ACTIVE-CONTROLLED, 5-WAY, PARALLEL GROUP STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND TOLERABILITY OF ONO-8539 IN PATIENTS WITH OVERACTIVE BLADDER
Phase 2
Completed
- Conditions
- overactive bladder/ urine incontinence10004994
- Registration Number
- NL-OMON33831
- Lead Sponsor
- ONO Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 70
Inclusion Criteria
1) medical history of OAB symptoms with urinary urgency for >6 months prior to screening
2) during the placebo run-in phase a) >8 micturitions per 24 hrs, and either b) >1 urgency episode per 24 hrs and >6 urgency episode per 72 hrs or c) >1 urinary urgency incontinence episode per 24 hrs (on each day recorded in the 3-day diary period).
Exclusion Criteria
History of lower urinary tract pathology that could be responsible for urgency or incontinence (e.g. genuine stress incontinence, bladder stones, interstitial cystitis, urothelial tumours), neurogenic detrusor overactivity and urinary tract infections.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary efficacy endpoint is the mean change from baseline in the number of<br /><br>micturitions per 24 hrs at 12 weeks. </p><br>
- Secondary Outcome Measures
Name Time Method