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| Tracking Information | |||||||||
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| First Received Date ICMJE | August 29, 2005 | ||||||||
| Last Updated Date | September 18, 2006 | ||||||||
| Start Date ICMJE | September 2003 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE |
chlorzoxazone metabolization rate before and after venesection | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00138684 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Cytochrome P450 2E1 and Iron Overload | ||||||||
| Official Title ICMJE | Cytochrome P450 2E1 and Iron Overload | ||||||||
| Brief Summary | The aim of the study is to determine, in patients presenting with insulin resistance and hepatic iron overload, the effects of venesection therapy on cytochrome P450 2E1 activity by comparing the rates of metabolization of chlorzoxazone before and after venesection. |
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| Detailed Description | |||||||||
| Study Phase | |||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Allocation: Randomized Control: Uncontrolled Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Procedure: venesection therapy | ||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 50 | ||||||||
| Completion Date | December 2005 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||||||
| Ages | 18 Years to 70 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | France | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00138684 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | DGS 2003/0052, PHRC/02-09, CIC0203/015 | ||||||||
| Study Sponsor ICMJE | Rennes University Hospital | ||||||||
| Collaborators ICMJE | Ministry of Health, France | ||||||||
| Investigators ICMJE |
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| Information Provided By | Rennes University Hospital | ||||||||
| Verification Date | September 2006 | ||||||||
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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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