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Effectiveness and Safety of Lidocaine for Scleroderma

This study has been completed.
Sponsor:
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

August 19, 2008
August 21, 2008
April 2004
April 2006   (final data collection date for primary outcome measure)
Skin thickening evaluated by Skin Score [ Time Frame: before, immediately after the intervention and 6 months later ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00740285 on ClinicalTrials.gov Archive Site
  • Safety - evaluated by the adverse effects during the intervention [ Time Frame: immediately after the intervention ] [ Designated as safety issue: Yes ]
  • Quality of Life evaluated by HAQ [ Time Frame: before, immediately after the intervention and 6 months later ] [ Designated as safety issue: No ]
  • Pressure at lower esophagus evaluated by esophagus manometry [ Time Frame: before, immediately after the intervention and 6 months later ] [ Designated as safety issue: No ]
  • Vessel alterations (as the number deletion/ectasia) evaluated by fingernail capillaroscopy [ Time Frame: before, immediately after the intervention and 6 months later ] [ Designated as safety issue: No ]
  • Subjective evaluation by patients [ Time Frame: before, immediately after the intervention and 6 months later ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effectiveness and Safety of Lidocaine for Scleroderma
Effectiveness and Safety of Lidocaine for Scleroderma. Randomized Double-Blind Clinical Trial

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Scleroderma
  • Drug: Lidocaine 2% without vessel constrictor
    • first 5 days: 20ml lidocaine 2% without vessel constrictor + physiological solution 0,9% 500ml intravenously during 4 hours
    • next 5 days: 30ml lidocaine 2% without vessel constrictor + physiological solution 0,9% 500ml intravenously during 4 hours total: 10 days
  • Other: Placebo - physiological solution 0,9%
    first 5 days: 20ml of physiological solution 0,9% 500ml + physiological solution 0,9% 500ml intravenously during 4 hours next 5 days: 30ml of physiological solution 0,9% 500ml + physiological solution 0,9% 500ml intravenously during 4 hours total: 10 days
  • Experimental: 1
    Intervention: Drug: Lidocaine 2% without vessel constrictor
  • Placebo Comparator: 2
    Intervention: Other: Placebo - physiological solution 0,9%
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 .

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
April 2007
April 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Scleroderma (diffuse or limited) at less than 5 years of the first symptom

Exclusion Criteria:

  • Overlap with other connective tissue diseases
  • Fibromyalgia
  • Pregnancy
  • Current use of ciclofosfamide ou D-penicillamine
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00740285
390/00
Yes
Not Provided
Federal University of São Paulo
Not Provided
Principal Investigator: Rachel Riera, MD Universidade Federal de São Paulo
Study Chair: Virginia FM Trevisani, PhD Universidade Federal de São Paulo
Study Director: Alexandre WS Silva, PhD Universidade Federal de São Paulo
Federal University of São Paulo
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP