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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00343486
• Date of registration: 21/06/2006
• Prospective Registration: No
• Primary sponsor: GlaxoSmithKline
• Public title: Dose Ranging Study Of Solabegron Versus Placebo In Female Patients With Overactive Bladder Symptoms
• Scientific title: An Eight- Week Randomized, Double-Blind, Placebo-Controlled, Parallel Group Proof of Concept Study to Assess the Efficacy, Safety and Tolerability as Well as the Pharmacokinetic Profile of Oral Solabegron (GW427353) 125mg and 50mg Administered Twice Daily vs Placebo in Women With Overactive Bladder
• Date of first enrolment: May 2006
• Target sample size: 240
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00343486
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Argentina, Australia, Finland, France, Germany, Italy, Korea, Republic of, Latvia, Netherlands, New Zealand, Poland, Slovenia, South Africa, Spain, Switzerland, Taiwan

Contacts

• Name: GSK Clinical Trials, MD
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Overactive Bladder

Intervention(s)

Drug: Solabegron

Primary Outcome(s)

Percent reduction in the number of incontinence episodes per 24 hrs after 8 weeks of treatment

Secondary Outcome(s)

Improvement overactive bladder symptoms per 24 hrs after 4 and 8 weeks of treatment. Improvement in health related Qol. Descriptive statistics of solabegron and it's primary metabolite.

Secondary ID(s)

B3P104833

M06-1605.

Source(s) of Monetary Support

Please refer to primary and secondary sponsors