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OpenTrials
Completed

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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Key information

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

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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

Solabegron

Drug

Primary outcomes

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

Secondary outcomes

  1. 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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