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
| Tracking Information | |||||
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| First Received Date ICMJE | June 21, 2006 | ||||
| Last Updated Date | May 15, 2009 | ||||
| Start Date ICMJE | May 2006 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Percent reduction in the number of incontinence episodes per 24 hrs after 8 weeks of treatment | ||||
| Original Primary Outcome Measures ICMJE |
Percent reduction in the number of incontinence episodes per 24 hrs after 8 weeks of treatment | ||||
| Change History | Complete list of historical versions of study NCT00343486 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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. | ||||
| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Dose Ranging Study Of Solabegron Versus Placebo In Female Patients With Overactive Bladder Symptoms | ||||
| Official Title ICMJE | 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 | ||||
| Brief Summary | 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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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
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| Condition ICMJE | Overactive Bladder | ||||
| Intervention ICMJE | Drug: Solabegron
Other Name: Solabegron |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 240 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Argentina, Australia, Finland, France, Germany, Korea, Republic of, Latvia, Netherlands, New Zealand, Poland, Slovenia, South Africa, Spain, Taiwan | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00343486 | ||||
| Other Study ID Numbers ICMJE | B3P104833, M06-1605. | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Study Director, GSK | ||||
| Study Sponsor ICMJE | GlaxoSmithKline | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | GlaxoSmithKline | ||||
| Verification Date | May 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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