A Placebo-Controlled Study of MK0634 in Patients With Overactive Bladder (0634-007)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00231790
First received: September 30, 2005
Last updated: April 4, 2012
Last verified: April 2012
  Purpose

Overactive bladder is very prevalent in postmenopausal women. The current study is designed to investigate whether a new drug may offer safe and effective treatment.


Condition Intervention Phase
Urinary Incontinence
Drug: MK-0634 50 mg
Drug: MK-0634 125 mg
Drug: Placebo for MK-0634
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-Controlled, Parallel-Group, Dose-Ranging Study of MK0634 in Postmenopausal Women With Overactive Bladder

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change from baseline in the number of micturitions per day averaged over a diary card week (4 to 10 days) [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
  • Proportion of participants with abnormal retinal photography (Follow-up Study 007 only) [ Time Frame: Day 1 of Follow-up ] [ Designated as safety issue: Yes ]
  • Proportion of participants with abnormal visual field test (Follow-up Study 007 only) [ Time Frame: Day 1 of Follow-up ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from baseline in the number of total incontinence episodes [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
  • Number of urge-incontinence episodes [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]
  • Number of urgency episodes per day averaged over a diary card week (4 to 10 days) [ Time Frame: up to 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 848
Study Start Date: September 2005
Study Completion Date: September 2009
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MK-0634 50 mg
All participants will receive placebo for the 1 week prior to randomization
Drug: MK-0634 50 mg
one capsule orally, once daily in morning
Other Name: L-000796568
Experimental: MK-0634 125 mg
All participants will receive placebo for the 1 week prior to randomization
Drug: MK-0634 125 mg
one or three capsules orally, once daily in morning
Other Name: L-000796568
Experimental: MK-0634 375 mg
All participants will receive placebo for the 1 week prior to randomization
Drug: MK-0634 125 mg
one or three capsules orally, once daily in morning
Other Name: L-000796568
Placebo Comparator: Placebo
All participants will receive placebo for the 1 week prior to randomization
Drug: Placebo for MK-0634
one, two, three or four capsules orally once daily in morning

Detailed Description:

Clinical development of MK-0634 was discontinued. Study MK-0634-027 was a safety follow-up study to determine if there were any ocular effects of MK-0634 in participants from the United Kingdom who were exposed to MK-0634 during the 007 study.

  Eligibility

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

Inclusion Criteria:

  • Postmenopausal females (ages 40-74) with predominantly urge urinary incontinence overactive bladder episodes.
  • Patients must meet minimum eligibility requirements (e.g., average number of micturitions/day) based on screening diary cards.

Exclusion Criteria:

  • Patients must not suffer from diabetes insipidus
  • Hyperglycemia
  • Hypercalcemia
  • Orthostatic hypotension
  • Active/recurrent urinary tract infections (>6 episodes per year)
  • Patients must be willing to discontinue their current OAB medication therapy.
  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: NCT00231790

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

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00231790     History of Changes
Other Study ID Numbers: 2005_045, MK0634-007 (027)
Study First Received: September 30, 2005
Last Updated: April 4, 2012
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 September 18, 2014