Study The Effects Of Different Doses Of UK-369,003 In Men With Overactive Bladder

March 11, 2011 updated by: Pfizer

A Multi-Center, Randomised, Parallel Group, Double-Blind, Placebo Controlled Estimation Study To Assess The Efficacy And Safety Of Modified Release UK-369,003 In The Treatment Of Men With Storage Lower Urinary Tract Symptoms (LUTS) With And Without Erectile Dysfunction (ED).

This is a 12 week study in which different doses of UK-369,003 will be administered to patients with a diagnosis of overactive bladder. Patients will complete a series of questionnaires before treatment, during treatment and after treatment, to assess whether UK-369,003 has improved their symptoms of overactive bladder and erectile function.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

275

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

  • Australia
    • New South Wales
      • Miranda, New South Wales, Australia, 2228
        • Pfizer Investigational Site
    • Queensland
      • Kippa Ring, Queensland, Australia, 4021
        • Pfizer Investigational Site
  • Canada
    • British Columbia
      • Victoria, British Columbia, Canada, V8T 5G1
        • Pfizer Investigational Site
    • Ontario
      • Barrie, Ontario, Canada, L4M 7G1
        • Pfizer Investigational Site
      • Kitchener, Ontario, Canada, N2N 2B9
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M6A 3B5
        • Pfizer Investigational Site
  • Chile
    • RM
      • Santiago, RM, Chile, 8380419
        • Pfizer Investigational Site
      • Santiago, RM, Chile, 8380456
        • Pfizer Investigational Site
    • VI Región
      • Rancagua, VI Región, Chile, 2820945
        • Pfizer Investigational Site
  • Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia
        • Pfizer Investigational Site
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia
        • Pfizer Investigational Site
  • Finland
      • Helsinki, Finland, 00100
        • Pfizer Investigational Site
      • Kouvola, Finland, 45200
        • Pfizer Investigational Site
      • Oulu, Finland, 90100
        • Pfizer Investigational Site
      • Tampere, Finland, 33100
        • Pfizer Investigational Site
      • Turku, Finland, 20100
        • Pfizer Investigational Site
  • France
      • Garches, France, 92380
        • Pfizer Investigational Site
      • Lyon Cedex 03, France, 69437
        • Pfizer Investigational Site
      • Montpellier, France, 34090
        • Pfizer Investigational Site
      • Paris, France, 75020
        • Pfizer Investigational Site
      • Rennes Cedex 9, France, 35033
        • Pfizer Investigational Site
  • Germany
      • Frankfurt, Germany, 65929
        • Pfizer Investigational Site
      • Marburg, Germany, 35039
        • Pfizer Investigational Site
      • Muelheim a.d. Ruhr, Germany, 45468
        • Pfizer Investigational Site
      • Muenchen, Germany, 81925
        • Pfizer Investigational Site
      • Rosenheim, Germany, 83022
        • Pfizer Investigational Site
  • Greece
    • Athens
      • Holargos, Athens, Greece, 15562
        • Pfizer Investigational Site
    • Ioannina
      • Epirus, Ioannina, Greece, 45500
        • Pfizer Investigational Site
    • Patras
      • Rio, Patras, Greece, 26500
        • Pfizer Investigational Site
  • Italy
      • Firenze, Italy, 50139
        • Pfizer Investigational Site
      • Latina, Italy, 04100
        • Pfizer Investigational Site
    • Palermo
      • Cefalu', Palermo, Italy, 90015
        • Pfizer Investigational Site
  • Latvia
      • Riga, Latvia, LV 1010
        • Pfizer Investigational Site
  • Norway
      • Moelv, Norway, N-2390
        • Pfizer Investigational Site
      • Oslo, Norway, NO-0257
        • Pfizer Investigational Site
  • Poland
      • Myslowice, Poland, 41-400
        • Pfizer Investigational Site
      • Poznan, Poland, 61-485
        • Pfizer Investigational Site
      • Szczecin, Poland, 70-111
        • Pfizer Investigational Site
      • Szczecin, Poland, 70-451
        • Pfizer Investigational Site
      • Szczecin, Poland, 70-467
        • Pfizer Investigational Site
      • Wroclaw, Poland, 53-020
        • Pfizer Investigational Site
  • Slovakia
      • Bratislava 37, Slovakia, 833 31
        • Pfizer Investigational Site
      • Kosice, Slovakia, 040 11
        • Pfizer Investigational Site
      • Martin, Slovakia, 036 59
        • Pfizer Investigational Site
      • Trencin, Slovakia, 911 01
        • Pfizer Investigational Site
  • Spain
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Pfizer Investigational Site
    • Palma de Mallorca
      • Manacor, Palma de Mallorca, Spain, 07500
        • Pfizer Investigational Site
  • Switzerland
      • Aarau, Switzerland, 5001
        • Pfizer Investigational Site
      • Zurich, Switzerland, 8091
        • Pfizer Investigational Site
  • United Kingdom
      • Leeds, United Kingdom, LS9 7TF
        • Pfizer Investigational Site
    • Newcastle upon Tyne
      • High Heaton, Newcastle upon Tyne, United Kingdom, NE7 7DN
        • Pfizer Investigational Site
    • Somerset
      • Taunton, Somerset, United Kingdom, TA1 5DA
        • Pfizer Investigational Site

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

Male

Description

Inclusion Criteria:

  • Male subjects aged 18 years and above
  • documented clinical diagnosis of overactive bladder with urinary frequency >= 8 times / 24 hours and number of urgency episodes > 1 episode / 24 hours.

Exclusion Criteria:

  • Neurological diseases known to affect bladder function.
  • Urinary tract infection.

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo
Experimental: Active
Drug: UK-369,003
UK-369,003 100mg, 50mg, 25mg and 10mg doses in addition to placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
This is an estimation study with no primary endpoint. There are efficacy endpoints.
Time Frame: 12 Weeks
12 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient reported treatment impact questionnaire.
Time Frame: 12 Weeks
12 Weeks
Lower urinary tract symptoms diary.
Time Frame: 12 Weeks
12 Weeks
International prostate symptom score questionnaire.
Time Frame: 12 Weeks
12 Weeks
OAB-q short form questionnaire.
Time Frame: 12 Weeks
12 Weeks
Patient perception of bladder control questionnaire.
Time Frame: 12 Weeks
12 Weeks
International index of erectile function questionnaire.
Time Frame: 12 Weeks
12 Weeks
International consultation on incontinence questionnaire.
Time Frame: 12 Weeks
12 Weeks
Quality of erection questionnaire.
Time Frame: 12 Weeks
12 Weeks

Collaborators and Investigators

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

Sponsor

Pfizer

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

Study Start

June 1, 2007

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

May 24, 2007

First Submitted That Met QC Criteria

May 25, 2007

First Posted (Estimate)

May 28, 2007

Study Record Updates

Last Update Posted (Estimate)

March 23, 2011

Last Update Submitted That Met QC Criteria

March 11, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A3711047

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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