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

Urinary Incontinence Clinical Trial

Official title:

A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Dose-Ranging Study of MK0634 in Postmenopausal Women With Overactive Bladder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00231790
• Other study ID #: 0634-007
• Secondary ID: 2005_045
• Status: Completed
• Phase: Phase 2
• First received: September 30, 2005
• Last updated: December 16, 2015
• Start date: August 2005
• Est. completion date: October 2006

Study information

• Verified date: December 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 848
• Est. completion date: October 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 74 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urinary Bladder, Overactive
• Urinary Incontinence

Intervention

Drug:
• MK-0634 50 mg
one capsule orally, once daily in morning
• MK-0634 125 mg
one or three capsules orally, once daily in morning
• Placebo for MK-0634
one, two, three or four capsules orally once daily in morning

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the number of micturitions per day averaged over a diary card week (4 to 10 days)		Baseline and Week 8	No
Primary	Proportion of participants with abnormal retinal photography (Follow-up Study 007 only)		Day 1 of Follow-up	Yes
Primary	Proportion of participants with abnormal visual field test (Follow-up Study 007 only)		Day 1 of Follow-up	Yes
Secondary	Change from baseline in the number of total incontinence episodes		Baseline and Week 8	No
Secondary	Number of urge-incontinence episodes		Up to 8 weeks	No
Secondary	Number of urgency episodes per day averaged over a diary card week (4 to 10 days)		up to 8 weeks	No