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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00479505
First received: May 24, 2007
Last updated: March 11, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Urinary Bladder, Overactive
Drug: UK-369,003
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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).

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • This is an estimation study with no primary endpoint. There are efficacy endpoints. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient reported treatment impact questionnaire. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Lower urinary tract symptoms diary. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • International prostate symptom score questionnaire. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • OAB-q short form questionnaire. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Patient perception of bladder control questionnaire. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • International index of erectile function questionnaire. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • International consultation on incontinence questionnaire. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Quality of erection questionnaire. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 275
Study Start Date: June 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active
N/A
Drug: UK-369,003
UK-369,003 100mg, 50mg, 25mg and 10mg doses in addition to placebo.
Placebo Comparator: Placebo
N/A
Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00479505

  Show 52 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00479505     History of Changes
Other Study ID Numbers: A3711047
Study First Received: May 24, 2007
Last Updated: March 11, 2011
Health Authority: France: Ministry of Health

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014