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

October 11, 2012 updated by: Ono Pharmaceutical Co. Ltd
The purpose of this study is to evaluate the efficacy and safety of ONO-8025 (KRP-197) in patients with overactive bladder.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

400

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 exclusion criteria as specified in the study protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Total number of urinary incontinence episodes per week

Secondary Outcome Measures

Outcome Measure
Number of micturition per day, number of urinary urgency episodes per day, volume voided per micturition and QOL

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ono Pharmaceutical Co. Ltd

Investigators

  • Study Director: Project Leader, Development Planning, Ono Pharmaceutical Co. Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2001

Primary Completion (Actual)

November 1, 2002

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 20, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

October 12, 2012

Last Update Submitted That Met QC Criteria

October 11, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONO-8025-06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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