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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00231790

Enrollment

848

Registered

2005-10-04

Start date

2005-08-31

Completion date

2006-10-31

Last updated

2015-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Incontinence

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.

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.

Interventions

DRUGMK-0634 50 mg

one capsule orally, once daily in morning

DRUGMK-0634 125 mg

one or three capsules orally, once daily in morning

DRUGPlacebo for MK-0634

one, two, three or four capsules orally once daily in morning

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

40 Years to 74 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026