Study of ONO-8539 in Patients With Overactive Bladder

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

A Randomised, Multi-Centre, Double-Blind, Placebo and Active-Controlled, 5-Way Parallel Group Study to Investigate the Efficacy, Safety and Tolerability of ONO-8539 in Patients With Overactive Bladder

The objective of this study is to investigate efficacy, safety and tolerability of ONO-8539 in patients with overactive bladder.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

435

Phase

  • Phase 2

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

  • Czech Republic
      • Brno, Czech Republic
      • Jindrichuv Hradec, Czech Republic
      • Olomouc, Czech Republic
      • Opava, Czech Republic
      • Plzen, Czech Republic
      • Praha, Czech Republic
      • Steti, Czech Republic
      • Usti Nad Labem, Czech Republic
  • Germany
      • Duisburg, Germany
      • Hagenow, Germany
      • Krumbach, Germany
      • Magdeburg, Germany
      • Mulheim, Germany
      • Weiden, Germany
  • Hungary
      • Budapest, Hungary
      • Dombovar, Hungary
      • Nyiregyhaza, Hungary
      • Szeged, Hungary
      • Szekszard, Hungary
  • Netherlands
      • Den Haag, Netherlands
      • Heerlen, Netherlands
      • Maastricht, Netherlands
      • Tilburg, Netherlands
      • Winterswijk, Netherlands
  • Poland
      • Bialystok, Poland
      • Bielsko-Biala, Poland
      • Gdansk, Poland
      • Gdynia, Poland
      • Katowice, Poland
      • Lodz, Poland
      • Lublin, Poland
      • Myslowice, Poland
      • Warszawa, Poland
  • Romania
      • Arad, Romania
      • Bihor, Romania
      • Bucharest, Romania
      • Timis, Romania
  • Russian Federation
      • Moscow, Russian Federation
      • Rostov-on-Don, Russian Federation
      • St. Petersburg, Russian Federation
  • Sweden
      • Goteborg, Sweden
      • Kungalv, Sweden
      • Stockholm, Sweden
      • Umea, Sweden
      • Uppsala, Sweden
  • Ukraine
      • Chernivtsi, Ukraine
      • Donetsk, Ukraine
      • Kharkiv, Ukraine
      • Kyiv, Ukraine
      • Zaporizhzhya, Ukraine

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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with medical history of Overactive Bladder symptoms for > 6 months

Exclusion Criteria:

  • Patients who have a history or presence of other significant diseases, which in the opinion of the investigator, might compromise the patient's safety or the evaluation of the study results

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
Drug: Tolterodine
4mg / 12 weeks
Placebo Comparator: P
Drug: Placebo
Placebo / 12 weeks
Experimental: E2
Drug: ONO-8539
low dose / 12 weeks
Drug: ONO-8539
medium dose / 12 weeks
Drug: ONO-8539
higher dose / 12 weeks
Experimental: E1
Drug: ONO-8539
low dose / 12 weeks
Drug: ONO-8539
medium dose / 12 weeks
Drug: ONO-8539
higher dose / 12 weeks
Experimental: E3
Drug: ONO-8539
low dose / 12 weeks
Drug: ONO-8539
medium dose / 12 weeks
Drug: ONO-8539
higher dose / 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overactive bladder symptoms
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Overactive bladder symptoms (QOL)
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

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

Sponsor

Ono Pharmaceutical Co. Ltd

Investigators

  • Study Director: Tomohiro Kuwayama, Clinical Development, ONO Pharma UK, 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

April 1, 2009

Primary Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

April 2, 2009

First Submitted That Met QC Criteria

April 3, 2009

First Posted (Estimate)

April 6, 2009

Study Record Updates

Last Update Posted (Estimate)

June 14, 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

  • ONO-8539POE004

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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