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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00343486
First received: June 21, 2006
Last updated: May 15, 2009
Last verified: May 2009

June 21, 2006
May 15, 2009
May 2006
Not Provided
Percent reduction in the number of incontinence episodes per 24 hrs after 8 weeks of treatment
Percent reduction in the number of incontinence episodes per 24 hrs after 8 weeks of treatment
Complete list of historical versions of study NCT00343486 on ClinicalTrials.gov Archive Site
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.
  • 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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Dose Ranging Study Of Solabegron Versus Placebo In Female Patients With Overactive Bladder Symptoms
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

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Overactive Bladder
Drug: Solabegron
Other Name: Solabegron
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Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
240
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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.
Female
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Australia,   Finland,   France,   Germany,   Korea, Republic of,   Latvia,   Netherlands,   New Zealand,   Poland,   Slovenia,   South Africa,   Spain,   Taiwan
 
NCT00343486
B3P104833, M06-1605.
Not Provided
Study Director, GSK
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
GlaxoSmithKline
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP