Dose Ranging Study Of Solabegron Versus Placebo In Female Patients With Overactive Bladder Symptoms

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

This study will test the effectiveness and safety of two doses of solabegron against placebo in reducing the symptoms of overactive bladder.

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

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Solabegron

Criteria

Inclusion Criteria:

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

• Body mass index in the range of = 19 kg/m2 to <35 kg/m2.

Exclusion Criteria:

• Pregnant

• Of childbearing potential or willing to use specific barrier methods outlined in the protocol.

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

• History of interstitial cystitis or bladder related pain.

• 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.

• 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.

• Current or history of Urinary Tract Infection.

• Diabetes insipidus.

• History of myocardial infarction, unstable angina, or Congestive heart failure.

• Chronic severe constipation.

• 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.

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