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

June 12, 2012 updated by: Ono Pharmaceutical Co. Ltd

An Open-label Study to Evaluate the Long-term Safety and Efficacy of Imidafenacin in Patients With Overactive Bladder

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

435

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Kanto, Japan
        • Kanto region
      • Kinki, Japan
        • Kinki region

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: E2
Drug: imidafenacin, KRP-197/ONO-8025
0.1 mg BID for 52 weeks
Drug: imidafenacin, KRP-197/ONO-8025
0.1 mg BID for 12 weeks and 0.2 mg BID for 52 weeks
Experimental: E1
Drug: imidafenacin, KRP-197/ONO-8025
0.1 mg BID for 52 weeks
Drug: imidafenacin, KRP-197/ONO-8025
0.1 mg BID for 12 weeks and 0.2 mg BID for 52 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety Measures: adverse events, laboratory tests, 12-lead ECG, vital signs, post-void residual volume
Time Frame: 64 weeks
64 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Efficacy measures: number of urgency incontinence episodes per week, number of incontinence episodes per week, number of micturitions per day, number of urgency episodes per day, severity of urgency, urine volume voided per micturition, Quality of Life
Time Frame: 64 weeks
64 weeks

Collaborators and Investigators

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

Sponsor

Ono Pharmaceutical Co. Ltd

Collaborators

Kyorin Pharmaceutical Co.,Ltd

Investigators

  • Study Director: Yoshifumi Hirahara, Kyorin Pharmaceutical Co.,Ltd
  • Study Chair: Toshihiko Konomi, 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

August 1, 2007

Primary Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

August 7, 2007

First Submitted That Met QC Criteria

August 7, 2007

First Posted (Estimate)

August 8, 2007

Study Record Updates

Last Update Posted (Estimate)

June 13, 2012

Last Update Submitted That Met QC Criteria

June 12, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KRP197-T301/ONO-8025-12

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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