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

Phase 2

Completed

• Conditions: Urinary Bladder, Overactive
• Interventions: Drug: UK-369,003; Drug: Placebo

• Registration Number: NCT00479505
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-05-24
• Study First Submitted QC: 2007-05-25
• Study First Posted: 2007-05-28
• Study Start: 2007-06
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Disposition First Submitted: 2009-03-24
• Status Verified: 2011-03
• Disposition First Submitted QC: 2011-03-11
• Last Update Submitted: 2011-03-11
• Disposition First Posted: 2011-03-23
• Last Update Posted: 2011-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 275

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active	UK-369,003	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
This is an estimation study with no primary endpoint. There are efficacy endpoints.	12 Weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇬🇧 Leeds, United Kingdom