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Effectiveness and Safety of Lidocaine for Scleroderma
This study has been completed.
Sponsor:
Federal University of São Paulo
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00740285
First received: August 19, 2008
Last updated: August 21, 2008
Last verified: August 2008
| Tracking Information | ||||||||||
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| First Received Date ICMJE | August 19, 2008 | |||||||||
| Last Updated Date | August 21, 2008 | |||||||||
| Start Date ICMJE | April 2004 | |||||||||
| 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 Outcome Measures ICMJE | Not Provided | |||||||||
| Original Other Outcome Measures ICMJE | 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 | Phase 2 Phase 3 |
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| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Scleroderma | |||||||||
| Intervention ICMJE |
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| Study Arms |
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| Publications * | 1. Atra E, Goldenberg J, Sasso WS. Proposição de um novo tratamento para esclerodermia utilizando o cloridrato de dietilamino 2,6 dimetilacetanilida. Revista Brasileira de Reumatologia 1977;maio/jun: 75-80. 2. Flickman PH, Jefrey JJ, Eifen V. Asensivity micritol Sd.ay for prolin hidroxilase activity in normal psoriatic skin. Jounal of Investigate tecnology 1973;60 (46). 3. White B, the ACR Comittee on Study Design and Response Parameters in SSc: Guidelines for clinical trials with disease-modifying intervention in systemic sclerosis (SSc). Arthritis Rheum 1993; 36 (suppl): S131 4. Jimenes AS, Hitraya E, Varga J. Pathogenesis of scleroderma: Collagen. In: Rheumatic Diseases Clinics of North America - Scleroderma 1996. 22(4):647 . | |||||||||
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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 | 26 | |||||||||
| Completion Date | April 2007 | |||||||||
| 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 |
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| Ages | 18 Years to 60 Years (Adult) | |||||||||
| Accepts Healthy Volunteers | 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 | |||||||||
| Plan to Share Data | Not Provided | |||||||||
| IPD Description | Not Provided | |||||||||
| Responsible Party | Not Provided | |||||||||
| Study Sponsor ICMJE | Federal University of São Paulo | |||||||||
| 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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