Controlled Study of ONO-8025 (KRP-197) in Patients With Overactive Bladder in Japan

Ono Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Overactive Bladder

Treatments: Drug: ONO-8025 (KRP-197)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00212732

ONO-8025-08

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of ONO-8025 (KRP-197) in patients with overactive bladder.

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients who are 20 years old or over with overactive bladder
2. Total number of urinary incontinence episodes per week is 5 or over
3. Mean number of micturition per day is 8 or over
4. Mean number of urinary urgency episodes per day is 1 or over
5. Other inclusion criteria as specified in the study protocol

Exclusion criteria

1. Patients with genuine stress incontinence
2. Patients suffering from complications such as bladder tumor, bladder stone and urinary tract infection
3. Patients who have undergone surgical operation of urinary and/or genital organs within 6 months prior to the study
4. Patients suffering from complications for which anticholinergics are contraindicated
5. Other exlcusion criteria as specified in the study protocol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind