Effectiveness and Safety of Lidocaine for Scleroderma
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00740285 |
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Recruitment Status :
Completed
First Posted : August 22, 2008
Last Update Posted : August 22, 2008
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Sponsor:
Federal University of São Paulo
Information provided by:
Federal University of São Paulo
| Tracking Information | ||||||||||
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| First Submitted Date ICMJE | August 19, 2008 | |||||||||
| First Posted Date ICMJE | August 22, 2008 | |||||||||
| Last Update Posted Date | August 22, 2008 | |||||||||
| Study Start Date ICMJE | April 2004 | |||||||||
| Actual Primary Completion Date | April 2006 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures ICMJE |
Skin thickening evaluated by Skin Score [ Time Frame: before, immediately after the intervention and 6 months later ] | |||||||||
| Original Primary Outcome Measures ICMJE | Same as current | |||||||||
| Change History | No Changes Posted | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| 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 | Effectiveness and Safety of Lidocaine for Scleroderma | |||||||||
| Official Title ICMJE | Effectiveness and Safety of Lidocaine for Scleroderma. Randomized Double-Blind Clinical Trial | |||||||||
| Brief Summary | Scleroderma, or systemic sclerosis, is a chronic connective tissue disease generally classified as one of the autoimmune rheumatic diseases. The disease is characterized by thickening and fibrosis skin, affecting vessels and many organs such as the esophagus, stomach, bowls, lung, heart and kidney. The exact cause or causes of scleroderma are still unknown, but scientists and medical investigators in a wide variety of fields are working hard to make those determinations. It is known that scleroderma involves overproduction of collagen. FLICKMAN et al, in 1973 published an article about the role of lidocaine at prolyl-hydroxylase activity decrease, which is an important enzyme of collagen production. Until now, there is only a case series showing the improvement of thickening skin (75%) and esophagus symptoms (66%) after intravenous lidocaine 2% during 10 days. So it is necessary a RCT to prove these findings. |
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| Detailed Description | Not Provided | |||||||||
| Study Type ICMJE | Interventional | |||||||||
| Study Phase ICMJE | Phase 2 Phase 3 |
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| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Scleroderma | |||||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Jimenez SA, Hitraya E, Varga J. Pathogenesis of scleroderma. Collagen. Rheum Dis Clin North Am. 1996 Nov;22(4):647-74. doi: 10.1016/s0889-857x(05)70294-5. | |||||||||
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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 | |||||||||
| Actual Enrollment ICMJE |
26 | |||||||||
| Original Actual Enrollment ICMJE | Same as current | |||||||||
| Actual Study Completion Date ICMJE | April 2007 | |||||||||
| Actual Primary Completion Date | April 2006 (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 | 18 Years to 60 Years (Adult) | |||||||||
| Accepts Healthy Volunteers ICMJE | No | |||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries ICMJE | Brazil | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number ICMJE | NCT00740285 | |||||||||
| Other Study ID Numbers ICMJE | 390/00 | |||||||||
| Has Data Monitoring Committee | Yes | |||||||||
| U.S. FDA-regulated Product | Not Provided | |||||||||
| IPD Sharing Statement ICMJE | Not Provided | |||||||||
| Current Responsible Party | Not Provided | |||||||||
| Original Responsible Party | Same as current | |||||||||
| Current Study Sponsor ICMJE | Federal University of São Paulo | |||||||||
| Original Study Sponsor ICMJE | Same as current | |||||||||
| Collaborators ICMJE | Not Provided | |||||||||
| Investigators ICMJE |
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| PRS Account | Federal University of São Paulo | |||||||||
| Verification Date | August 2008 | |||||||||
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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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