Effect of Goserelin (Zoladex®) in Spinal and Bulbar Muscular Atrophy
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ClinicalTrials.gov Identifier: NCT00851461 |
Recruitment Status :
Completed
First Posted : February 26, 2009
Last Update Posted : May 21, 2015
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Sponsor:
Ramathibodi Hospital
Collaborator:
AstraZeneca
Information provided by:
Ramathibodi Hospital
Tracking Information | ||||
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First Submitted Date ICMJE | February 25, 2009 | |||
First Posted Date ICMJE | February 26, 2009 | |||
Last Update Posted Date | May 21, 2015 | |||
Study Start Date ICMJE | April 2008 | |||
Actual Primary Completion Date | November 2011 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
muscle power [ Time Frame: every 3 months ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
electrophysiologic study (Nerve conduction and Electromyogram) [ Time Frame: every 3 months ] | |||
Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Effect of Goserelin (Zoladex®) in Spinal and Bulbar Muscular Atrophy | |||
Official Title ICMJE | Effect of Goserelin (Zoladex®) in Spinal and Bulbar Muscular Atrophy in Thai Patients | |||
Brief Summary | This is a therapeutic trial study to demonstrate whether Goserelin, a LHRH agonist has benefit in SBMA Objective:
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Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE | Not Provided | |||
Publications * | Not Provided | |||
* 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 | |||
Actual Enrollment ICMJE |
10 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | November 2013 | |||
Actual Primary Completion Date | November 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 20 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Thailand | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00851461 | |||
Other Study ID Numbers ICMJE | ID11-50-17 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Dean of Ramathibodi Hospital, Faculty of Medicine, Ramathibodi Hospital, Bangkok, Thailand | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | Ramathibodi Hospital | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | AstraZeneca | |||
Investigators ICMJE |
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PRS Account | Ramathibodi Hospital | |||
Verification Date | February 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |