Study to Compare the Safety and Efficacy of Solifenacin With Oxybutynin for the Treatment of Overactive Bladder (VECTOR)

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the safety and efficacy of solifenacin with oxybutynin immediate-release (IR) for the treatment of overactive bladder (OAB).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Collaborator: Astellas Pharma Canada, Inc.
• Treatments: Mandelic Acids; Oxybutynin; Solifenacin Succinate

Criteria

Inclusion Criteria:

• Adults 18 years and older.

• Overactive bladder symptoms for greater than or equal to 3 months and as documented in a 3-day patient diary following screening and preceding baseline visit: > 1 urge episodes/24 hours (average); greater than or equal to 8 micturitions/24 hours (average)

Exclusion Criteria:

• Urinary tract infection, chronic inflammation such as interstitial cystitis and bladder stones

• Clinically significant outflow obstruction

• Uncontrolled narrow angle glaucoma, urinary, or gastric retention

• Severe renal or hepatic impairment

• Chronic severe constipation or history of diagnosed GI obstructive disease

• Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor

• Diagnosis or history of neurogenic bladder

• History of bladder or pelvic cancer