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
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, see Learn About Clinical Studies.

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
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Urinary Bladder Diseases

ClinicalTrials.gov processed this record on August 01, 2014