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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

435 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT00212732

Overactive Bladder

COMPLETED PHASE3

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

NCT00212706

Overactive Bladder

COMPLETED PHASE2

Comparison of Efficacy and Safety Between Imidafenacin and Fesoterodine in Patients With Overactive Bladder

NCT01578304

Overactive Bladder

COMPLETED PHASE4

Study of ONO-8577 in Patients With Overactive Bladder

NCT03106623

Overactive Bladder

COMPLETED PHASE2

A Long-term Study of YM178 in Symptomatic Overactive Bladder Patients

NCT00840645

Urinary Bladder, Overactive

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Overactive Bladder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

E1

Group Type EXPERIMENTAL

imidafenacin, KRP-197/ONO-8025

Intervention Type DRUG

0.1 mg BID for 52 weeks

E2

Group Type EXPERIMENTAL

imidafenacin, KRP-197/ONO-8025

Intervention Type DRUG

0.1 mg BID for 12 weeks and 0.2 mg BID for 52 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

imidafenacin, KRP-197/ONO-8025

0.1 mg BID for 52 weeks

Intervention Type DRUG

imidafenacin, KRP-197/ONO-8025

0.1 mg BID for 12 weeks and 0.2 mg BID for 52 weeks

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No