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

Merck Sharp & Dohme (MSD) logo

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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