Dose Ranging Study Of Solabegron Versus Placebo In Female Patients With Overactive Bladder Symptoms
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ClinicalTrials.gov Identifier: NCT00343486 |
Recruitment Status :
Completed
First Posted : June 23, 2006
Last Update Posted : May 18, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Overactive Bladder | Drug: Solabegron | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 240 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
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 |
Study Start Date : | May 2006 |

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

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00343486

Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | Study Director, GSK |
ClinicalTrials.gov Identifier: | NCT00343486 |
Other Study ID Numbers: |
B3P104833 M06-1605. |
First Posted: | June 23, 2006 Key Record Dates |
Last Update Posted: | May 18, 2009 |
Last Verified: | May 2009 |
Overactive Bladder |
Urinary Bladder, Overactive Urinary Bladder Diseases Urologic Diseases Lower Urinary Tract Symptoms Urological Manifestations Solabegron Adrenergic beta-3 Receptor Agonists |
Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |