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

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:

MedlinePlus related topics: Overactive Bladder Urine and Urination

U.S. FDA Resources

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:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

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 June 13, 2013