A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase II Study of MK0594 in Patients With Overactive Bladder - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00290563

Purpose

This study is designed to investigate whether a new drug may offer safe and effective treatment for patients with overactive bladder.

Condition	Intervention	Phase
Urinary Incontinence Overactive Bladder	Drug: MK0594	Phase II

MedlinePlus related topics: Urinary Incontinence Urine and Urination

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Double-Blind, Randomized, Placebo- and Active-Controlled, Parallel-Group, Dose-Ranging Study of MK0594 in Patients With Overactive Bladder

Further study details as provided by Merck:

Primary Outcome Measures:

Change in baseline in average daily micturitions as recorded on patient voiding diaries. [ Time Frame: Duration of Trial ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The incidence of dry mouth. [ Time Frame: Duration of Treatment ] [ Designated as safety issue: No ]
Average daily strong urgency, total incontinence, and Urge UI episodes from voiding diaries. [ Time Frame: Duration of Treatment ] [ Designated as safety issue: No ]
Global assessment of improvement in UI, perception of urgency, and bother of UI symptoms. [ Time Frame: Duration of Treatment ] [ Designated as safety issue: No ]

Enrollment:	530
Study Start Date:	February 2006
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Eligibility

Criteria

Inclusion Criteria:

Patients with predominantly urge incontinence overactive bladder episodes
Patients must meet minimum eligibility requirements (e.g., average number of micturitions/day) based on screening diary cards

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00290563

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2005_102, MK0594-003
Study First Received:	February 10, 2006
Last Updated:	May 13, 2008
ClinicalTrials.gov Identifier:	NCT00290563
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Signs and Symptoms
Urinary Bladder, Overactive
Cystocele
Urologic Diseases

Urination Disorders
Urinary Bladder Diseases
Urinary Incontinence

Additional relevant MeSH terms:

Urological Manifestations

ClinicalTrials.gov processed this record on January 16, 2009