Long-term Safety and Efficacy of Imidafenacin in Patients With Overactive Bladder

Ono Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Overactive Bladder

Treatments: Drug: imidafenacin, KRP-197/ONO-8025

Study type: Interventional

Funder types: Industry

Identifiers

NCT00512785

KRP197-T301/ONO-8025-12

Details and patient eligibility

About

The purpose of this study is to evaluate the long-term safety and efficacy of imidafenacin.

Enrollment: 435 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and Woman equal or > 20 years old
• Patients with urgency, urinary frequency and urgency incontinence

Exclusion criteria

• Patients with genuine stress incontinence
• Patients suffering from complications such as bladder tumor, urinary tract stone and symptomatic urinary tract infection
• Patients suffering from complications contraindicating the use of antimuscarinic medication
• Patients with polyuria

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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435 participants in 2 patient groups

E1

Experimental group

Treatment:

Drug: imidafenacin, KRP-197/ONO-8025

Drug: imidafenacin, KRP-197/ONO-8025

E2

Experimental group

Treatment:

Drug: imidafenacin, KRP-197/ONO-8025

Drug: imidafenacin, KRP-197/ONO-8025