Last updated: 07/14/2020 14:50:05
Dose Ranging Study Of Solabegron Versus Placebo In Female Patients With Overactive Bladder Symptoms
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: This study will test the effectiveness and safety of two doses of solabegron against placebo in reducing the symptoms of overactive bladder.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Percent reduction in the number of incontinence episodes per 24 hrs after 8 weeks of treatment
Timeframe: Baseline to Week 8.
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.
Timeframe: Baseliine to Week 4 and Week 8.
Interventions:
Drug: Solabegron
Enrollment:
240
Observational study model:
Not applicable
Primary completion date:
2007-15-02
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Overactive Bladder
Product
solabegron
Collaborators
Not applicable
Study date(s)
May 2006 to February 2007
Type
Interventional
Phase
2
Participation criteria
Sex
Female
Age
18 - 80 Years
Accepts healthy volunteers
no
- 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.
- Pregnant
- Of childbearing potential or willing to use specific barrier methods outlined in the protocol.
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
Av Córdoba 2424, Buenos Aires, Argentina, 1120
Status
Study Complete
Location
GSK Investigational Site
Caboolture, Queensland, Australia, 4510
Status
Study Complete
Location
GSK Investigational Site
Ciudad de Buenos Aires, Buenos Aires, Argentina, C1425BGV
Status
Study Complete
Location
GSK Investigational Site
Dessau, Sachsen-Anhalt, Germany, 06844
Status
Study Complete
Location
GSK Investigational Site
Kippa Ring, Queensland, Australia, 4021
Status
Study Complete
Location
GSK Investigational Site
Magdeburg, Sachsen-Anhalt, Germany, 39112
Status
Study Complete
Location
GSK Investigational Site
Randwick, New South Wales, Australia, 2031
Status
Study Complete
Location
GSK Investigational Site
Spring Hill, Victoria, Australia, 4000
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
2007-15-02
Actual study completion date
2007-15-02
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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