Dose Ranging Study Of Solabegron Versus Placebo In Female Patients With Overactive Bladder Symptoms
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00343486
First received: June 21, 2006
Last updated: May 15, 2009
Last verified: May 2009
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Purpose
This study will test the effectiveness and safety of two doses of solabegron against placebo in reducing the symptoms of overactive bladder.
| Condition | Intervention | Phase |
|---|---|---|
|
Overactive Bladder |
Drug: Solabegron |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official 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 |
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Percent reduction in the number of incontinence episodes per 24 hrs after 8 weeks of treatment
Secondary Outcome Measures:
- 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.
| Estimated Enrollment: | 240 |
| Study Start Date: | May 2006 |
Intervention Details:
-
Drug: Solabegron
Other Name: Solabegron
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00343486
Show 66 Study Locations
Show 66 Study LocationsSponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
More Information
No publications provided
| Responsible Party: | Study Director, GSK |
| ClinicalTrials.gov Identifier: | NCT00343486 History of Changes |
| Other Study ID Numbers: | B3P104833, M06-1605. |
| Study First Received: | June 21, 2006 |
| Last Updated: | May 15, 2009 |
| Health Authority: | Taiwan: Department of Health |
Keywords provided by GlaxoSmithKline:
|
Overactive Bladder |
Additional relevant MeSH terms:
|
Urinary Bladder, Overactive Urinary Bladder Diseases Urologic Diseases Urological Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013