Trial intelligence / Profile preview

Phase 3 Study of Imidafenacin in Overactive Bladder

NCT00212732Phase 3

Key facts

Status: Completed
Start: Oct 2003
Primary completion: Apr 2006
Sponsor: Ono Pharmaceutical
Modality: Small Molecules

Drugs: imidafenacin
Conditions: overactive bladder (OAB)

Overview

Phase 3, randomised, double-blind trial of imidafenacin in overactive bladder (OAB) (3 arms), sponsored by Ono Pharmaceutical. Primary endpoint: Total number of urinary incontinence episodes per week at 12 weeks. Started Oct 2003; status: completed.

Design

3 arms

Study design: RandomizedDouble-blind

Imidafenacin
Imidafenacin 0.1 mg twice daily
Placebo
Placebo
Propiverine
Propiverine hydrochloride (Active Control)

Who it enrols

Adult patients (>=20 years) with overactive bladder symptoms including incontinence, urgency, and frequency, excluding those with stress incontinence, bladder tumors, stones, or UTIs.

Endpoints

Primary

Total number of urinary incontinence episodes per week12 weeks

Secondary

Number of micturition per day12 weeks
Number of urinary urgency episodes per day12 weeks
Volume voided per micturition12 weeks
Quality of Life12 weeks

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