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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014