A Study Of GW679769 Compared To Placebo In Women With Overactive Bladder

• Status: Completed
• Trial end date: 2007-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

This is a Phase IIa study to evaluate the efficacy, safety and tolerability of GW679769 vs placebo on symptoms of urgency with urge incontinence, frequency and nocturia associated with overactive bladder in women.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Casopitant

Criteria

Inclusion Criteria:

• Female subjects with overactive bladder with symptoms of urgency with urge incontinence and frequency which may be associated with nocturia but without bladder pain.

• Must not be pregnant.

• Must not be of childbearing potential or is willing to use specific barrier methods outlined in the protocol.

• Body weight in the range of = 45 kg and <100 kg.

Exclusion Criteria:

• Stage III/IV pelvic organ prolapse with or without cystocele.

• History of interstitial cystitis or bladder related pain.

• Subjects with stress incontinence or mixed incontinence where stress incontinence is the predominant component based on prior history.

• History of pelvic prolapse repair (cystocele or rectocele) or urethral diverticulectomy within six months of screening.

• Subjects with urinary incontinence due to causes other then detrusor over activity (e.g., overflow incontinence).

• Nocturnal enuresis only.

• Urinary retention, or other evidence of poor detrusor function.

• History of prior anti-incontinence surgery.

• History of radiation cystitis or a history of pelvic irradiation.

• Electrostimulation, biofeedback, or bladder training therapy (behavioral therapy) during the previous month prior to screening, or the intention to initiate such therapies during the study. Pessaries and implants are also excluded.

• Participated in any clinical trial of an investigation drug that may affect urinary function within 3 months of enrollment into the study.

• Received any investigational product within 30 days of enrollment into the study.