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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Urinary Incontinence

Treatments: Drug: Placebo for MK-0634; Drug: MK-0634 50 mg; Drug: MK-0634 125 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00231790

0634-007

2005_045

Details and patient eligibility

About

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.

Full 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.

Enrollment: 848 patients

Sex: Female

Ages: 40 to 74 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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848 participants in 4 patient groups, including a placebo group

MK-0634 50 mg

Experimental group

Description:

All participants will receive placebo for the 1 week prior to randomization

Treatment:

Drug: MK-0634 50 mg

MK-0634 125 mg

Experimental group

Description:

All participants will receive placebo for the 1 week prior to randomization

Treatment:

Drug: MK-0634 125 mg

MK-0634 375 mg

Experimental group

Description:

All participants will receive placebo for the 1 week prior to randomization

Treatment:

Drug: MK-0634 125 mg

Placebo

Placebo Comparator group

Description:

All participants will receive placebo for the 1 week prior to randomization

Treatment:

Drug: Placebo for MK-0634