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MK-0634

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment848

FDA Designations

No designations recorded

Clinical trial landscape

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 Incontinence
NCT00231790848
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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 used for?

MK-0634 is an investigational small molecule being developed for the treatment of urinary incontinence, specifically studied in patients with overactive bladder. It is in Phase 2 clinical development and is not yet approved by regulatory authorities.

Who makes MK-0634?

MK-0634 is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The drug is currently in Phase 2 clinical development for urinary incontinence.

What phase is MK-0634 in?

MK-0634 is in Phase 2 clinical development. It has completed one Phase 2 trial, which was a randomized, double-blind, placebo-controlled study. The drug remains investigational and has not been approved for any use.

What clinical trials is MK-0634 in?

MK-0634 has one completed clinical trial, identified as NCT00231790, titled 'A Placebo-Controlled Study of MK0634 in Patients With Overactive Bladder (0634-007)'. This Phase 2 study enrolled 848 female patients aged 40 years and older with urinary incontinence.

Is MK-0634 FDA approved?

MK-0634 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for urinary incontinence. The completed Phase 2 trial was a placebo-controlled study, but the drug has not yet received regulatory approval.