A Placebo-Controlled Study of MK0634 in Patients With Overactive Bladder (0634-007)
A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Dose-Ranging Study of MK0634 in Postmenopausal Women With Overactive Bladder
2 other identifiers
interventional
848
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2005
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 30, 2005
CompletedFirst Posted
Study publicly available on registry
October 4, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2006
CompletedDecember 17, 2015
December 1, 2015
1.1 years
September 30, 2005
December 16, 2015
Conditions
Outcome Measures
Primary Outcomes (3)
Change from baseline in the number of micturitions per day averaged over a diary card week (4 to 10 days)
Baseline and Week 8
Proportion of participants with abnormal retinal photography (Follow-up Study 007 only)
Day 1 of Follow-up
Proportion of participants with abnormal visual field test (Follow-up Study 007 only)
Day 1 of Follow-up
Secondary Outcomes (3)
Change from baseline in the number of total incontinence episodes
Baseline and Week 8
Number of urge-incontinence episodes
Up to 8 weeks
Number of urgency episodes per day averaged over a diary card week (4 to 10 days)
up to 8 weeks
Study Arms (4)
MK-0634 50 mg
EXPERIMENTALAll participants will receive placebo for the 1 week prior to randomization
MK-0634 125 mg
EXPERIMENTALAll participants will receive placebo for the 1 week prior to randomization
MK-0634 375 mg
EXPERIMENTALAll participants will receive placebo for the 1 week prior to randomization
Placebo
PLACEBO COMPARATORAll participants will receive placebo for the 1 week prior to randomization
Interventions
one or three capsules orally, once daily in morning
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2005
First Posted
October 4, 2005
Study Start
August 1, 2005
Primary Completion
September 1, 2006
Study Completion
October 1, 2006
Last Updated
December 17, 2015
Record last verified: 2015-12