A Study of YM178 in Patients With Symptomatic Overactive Bladder (DRAGON)

July 1, 2013 updated by: Astellas Pharma Inc

A Randomized, Double-blind, Parallel Group, Placebo and Active Controlled, Multicenter Dose Ranging Study With the Beta-3 Agonist YM178 in Patients With Symptomatic Overactive Bladder

The study will examine which dose of YM178 is best in terms of efficacy, safety and tolerability compared to placebo and compared to tolterodine, a marketed product.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1108

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

  • Belgium
      • Antwerp, Belgium
        • 3 Sites
      • Brussels, Belgium
        • 2 Sites
      • Gent, Belgium
      • Leuven, Belgium
      • Liege, Belgium
  • Czech Republic
      • Brno, Czech Republic
      • Melnik, Czech Republic
      • Ostrava, Czech Republic
      • Prague, Czech Republic
        • 3 Sites
      • Usti nad Labem, Czech Republic
      • Zlin, Czech Republic
  • Denmark
      • Holbaek, Denmark
      • Kolding, Denmark
      • Roskilde, Denmark
  • France
      • Nantes, France
        • 2 Sites
      • Paris, France
        • 2 Sites
  • Germany
      • Bad Ems, Germany
      • Bamberg, Germany
      • Bautzen, Germany
      • Berlin, Germany
      • Dresden, Germany
      • Frankfurt, Germany
      • Hagenow, Germany
      • Halle/Saale, Germany
      • Hamburg, Germany
      • Koblenz, Germany
      • Leipzig, Germany
      • Munchen, Germany
      • Radebeul, Germany
      • Trier, Germany
      • Uetersen, Germany
  • Greece
      • Athens, Greece
        • 3 Sites
      • Patras, Greece
  • Hungary
      • Miskolc, Hungary
      • Nyiregyhaza, Hungary
      • Pecs, Hungary
      • Sopron, Hungary
      • Szeged, Hungary
      • Tatabanya, Hungary
  • Italy
      • Catanzaro, Italy
      • Milano, Italy
      • Modena, Italy
      • Padova, Italy
      • Roma, Italy
      • Sassari, Italy
      • Torino, Italy
      • Udine, Italy
      • Varese, Italy
  • Netherlands
      • Amsterdam, Netherlands
      • Apeldoorn, Netherlands
      • Arnhem, Netherlands
      • Eindhoven, Netherlands
      • Enschede, Netherlands
      • Maastricht, Netherlands
  • Norway
      • Bergen, Norway
      • Oslo, Norway
      • Tonsberg, Norway
  • Poland
      • Bialystok, Poland
      • Katowice, Poland
      • Kielce, Poland
      • Lublin, Poland
      • Warszawa, Poland
        • 3 Sites
      • Wroclaw, Poland
        • 3 Sites
  • Russian Federation
      • Moscow, Russian Federation
        • 7 Sites
      • St Petersburg, Russian Federation
        • 3 Sites
  • Spain
      • Barcelona, Spain
        • 2 Sites
      • Bilbao, Spain
      • Madrid, Spain
        • 2 Sites
      • Manacor, Spain
      • Miranda de Ebro, Spain
      • San Juan de Alica, Spain
      • Sevilla, Spain
      • Vigo, Spain
  • Sweden
      • Gothenburg, Sweden
      • Stockholm, Sweden
        • 2 Sites
  • United Kingdom
      • Birmingham, United Kingdom
      • Blackburn, United Kingdom
      • Chichester, United Kingdom
      • Croydon, United Kingdom
      • London, United Kingdom
      • Reading, United Kingdom
      • Sheffield, United Kingdom
      • Southampton, United Kingdom
      • Swansea, United Kingdom

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:

  • Patients over 18 years suffering from overactive bladder (OAB) for more than 3 months

Exclusion Criteria:

  • Pregnant and breastfeeding women
  • Any medical condition or need for co-medication which interferes with the drug under investigation (YM178) or the comparator (tolterodine)

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
  • Masking: DOUBLE

Collaborators and Investigators

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

Sponsor

Astellas Pharma Inc

Collaborators

Astellas Pharma Europe B.V.

Investigators

  • Study Chair: Astellas Pharma, Astellas Pharma Europe B.V.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

Primary Completion (ACTUAL)

March 1, 2007

Study Completion (ACTUAL)

March 1, 2007

Study Registration Dates

First Submitted

June 14, 2006

First Submitted That Met QC Criteria

June 14, 2006

First Posted (ESTIMATE)

June 15, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

July 2, 2013

Last Update Submitted That Met QC Criteria

July 1, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 178-CL-044

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.

Clinical Trials on Overactive Bladder

Clinical Trials on YM178

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zimbabwe

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe