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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00479505
Recruitment Status : Completed
First Posted : May 28, 2007
Last Update Posted : March 23, 2011
Information provided by:

Brief Summary:
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 or disease Intervention/treatment Phase
Urinary Bladder, Overactive Drug: UK-369,003 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 275 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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).
Study Start Date : June 2007
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. This is an estimation study with no primary endpoint. There are efficacy endpoints. [ Time Frame: 12 Weeks ]

Secondary Outcome Measures :
  1. Patient reported treatment impact questionnaire. [ Time Frame: 12 Weeks ]
  2. Lower urinary tract symptoms diary. [ Time Frame: 12 Weeks ]
  3. International prostate symptom score questionnaire. [ Time Frame: 12 Weeks ]
  4. OAB-q short form questionnaire. [ Time Frame: 12 Weeks ]
  5. Patient perception of bladder control questionnaire. [ Time Frame: 12 Weeks ]
  6. International index of erectile function questionnaire. [ Time Frame: 12 Weeks ]
  7. International consultation on incontinence questionnaire. [ Time Frame: 12 Weeks ]
  8. Quality of erection questionnaire. [ Time Frame: 12 Weeks ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00479505

  Show 52 Study Locations
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc Identifier: NCT00479505     History of Changes
Other Study ID Numbers: A3711047
First Posted: May 28, 2007    Key Record Dates
Last Update Posted: March 23, 2011
Last Verified: March 2011

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