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MK-0634

Phase 2

Urinary Incontinence | Small molecule | Nephrology |Merck & Company, Inc.|Trials Updated: Dec 17, 2015

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment848

FDA Designations

No designations recorded

MK-0634 clinical trials

MK-0634 · 1 trial · 1 indication

Phase 2 1
NCT00231790A Placebo-Controlled Study of MK0634 in Patients With Overactive Bladder (0634-007)Urinary Incontinence
COMPLETED848 Analytics
PHASE2COMPLETED
A Placebo-Controlled Study of MK0634 in Patients With Overactive Bladder (0634-007)
Urinary IncontinenceUnlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MK-0634 50 mgEXPERIMENTALAll participants will receive placebo for the 1 week prior to randomization
MK-0634 125 mgEXPERIMENTALAll participants will receive placebo for the 1 week prior to randomization
MK-0634 375 mgEXPERIMENTALAll participants will receive placebo for the 1 week prior to randomization
PlaceboPLACEBO_COMPARATORAll participants will receive placebo for the 1 week prior to randomization

Interventions

NameTypeDescription
MK-0634 50 mgDRUGone capsule orally, once daily in morning
MK-0634 125 mgDRUGone or three capsules orally, once daily in morning
Placebo for MK-0634DRUGone, two, three or four capsules orally once daily in morning
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Eligibility Criteria

Age Range40 Years to 74 Years
SexFEMALE
Healthy VolunteersNo

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 ...

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Frequently asked questions about MK-0634

What is MK-0634?

MK-0634 is an investigational small molecule developed by Merck & Company, Inc. (ticker MRK) for urinary incontinence. It has been studied in a Phase 2 clinical trial in patients with overactive bladder. MK-0634 is also known as MK-0634 50 mg.

What is MK-0634 used for?

MK-0634 is being studied for urinary incontinence, specifically in patients with overactive bladder. The Phase 2 trial enrolled women aged 40 years and older with this condition. It is an investigational therapy and has not been approved for commercial use.

Who makes MK-0634?

MK-0634 is developed by Merck & Company, Inc., which trades under the ticker MRK. Merck sponsored the Phase 2 clinical program evaluating the drug in urinary incontinence.

What phase is MK-0634 in?

MK-0634 is in Phase 2 development. One Phase 2 trial has been completed, and no trials are currently active. The completed study was a randomized, double-blind, placebo-controlled trial in patients with overactive bladder.

What clinical trials is MK-0634 in?

MK-0634 has been evaluated in one completed Phase 2 trial, NCT00231790, titled A Placebo-Controlled Study of MK0634 in Patients With Overactive Bladder (0634-007). The trial enrolled 848 participants, was randomized, double-blind, and placebo-controlled, and studied women aged 40 years and older with urinary incontinence.