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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00290563
First Posted: February 13, 2006
Last Update Posted: December 15, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Merck Sharp & Dohme Corp.
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]

Secondary Outcome Measures:
  • The incidence of dry mouth. [ Time Frame: Duration of Treatment ]
  • Average daily strong urgency, total incontinence, and Urge UI episodes from voiding diaries. [ Time Frame: Duration of Treatment ]
  • Global assessment of improvement in UI, perception of urgency, and bother of UI symptoms. [ Time Frame: Duration of Treatment ]

Enrollment: 557
Study Start Date: February 2006
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00290563


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

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
First Submitted: February 10, 2006
First Posted: February 13, 2006
Last Update Posted: December 15, 2009
Last Verified: December 2009

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urinary Bladder, Overactive
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Urinary Bladder Diseases