Safety and Efficacy of MK0594 to Treat Overactive Bladder (0594-003)

Vyne Therapeutics

Status and phase: Completed; Phase 2

Conditions: Urinary Incontinence; Overactive Bladder

Treatments: Drug: MK0594

Study type: Interventional

Funder types: Industry

Identifiers

NCT00290563

MK0594-003

0594-003

2005_102

Details and patient eligibility

About

This study is designed to investigate whether a new drug may offer safe and effective treatment for patients with overactive bladder.

Enrollment: 557 patients

Sex: All

Ages: 40 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with predominantly urge incontinence overactive bladder episodes
• Patients must meet minimum eligibility requirements (e.g., average number of micturitions/day) based on screening diary cards

Exclusion criteria

• History of Diabetes insipidus, uncontrolled hyperglycemia or hypercalcemia
• Lower urinary tract symptoms associated with benign prostatic hypertrophy
• Active or current Urinary Tract Infections (UTIs)
• Surgery to correct prolapsed uterus or stress incontinence

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind