NCT Number: NCT00343486
Dose Ranging Study Of Solabegron Versus Placebo In Female Patients With Overactive Bladder Symptoms
This study will test the effectiveness and safety of two doses of solabegron against placebo in reducing the symptoms of overactive bladder.
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Notify MeKey information
Conditions
Age range
18 year–80 year
Sex eligibility
Female
Study type
Interventional
Phase
Phase 2
Primary location
GSK Investigational Site, Av Córdoba 2424, Buenos Aires, Argentina
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
-
Percent reduction in the number of incontinence episodes per 24 hrs after 8 weeks of treatment
Secondary outcomes
-
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.
Sponsors and collaborators
Lead sponsor
GlaxoSmithKline
Industry
Registry information
Official study 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
Important dates
- Study start
- 2006
- First posted
- Jun 23, 2006
- Registry last updated
- May 18, 2009
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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