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

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00290563
First received: February 10, 2006
Last updated: December 14, 2009
Last verified: December 2009
  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 2

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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

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: 557
Study Start Date: February 2006
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: MK0594
    Other Name: MK0594
  Eligibility

Ages Eligible for Study:   40 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

  • History of Diabetes insipidus, uncontrolled hyperglycemia or hypercalcemia
  • Lower urinary tract symptoms associated with benign prostatic hypertrophy
  • Active or current Urinary Tract Infections (UTIs)
  • Surgery to correct prolapsed uterus or stress incontinence
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00290563

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided by Merck Sharp & Dohme Corp.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00290563     History of Changes
Other Study ID Numbers: 2005_102, MK0594-003
Study First Received: February 10, 2006
Last Updated: December 14, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Bladder, Overactive
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Urinary Bladder Diseases

ClinicalTrials.gov processed this record on April 16, 2014