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Effectiveness and Safety of Lidocaine for Scleroderma

NCT00740285 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2008-08-22

No results posted yet for this study

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.

Conditions

  • Scleroderma

Interventions

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

Sponsors & Collaborators

  • Federal University of São Paulo

    lead OTHER

Principal Investigators

  • Rachel Riera, MD · Universidade Federal de São Paulo

  • Virginia FM Trevisani, PhD · Universidade Federal de São Paulo

  • Alexandre WS Silva, PhD · Universidade Federal de São Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-04-30
Primary Completion
2006-04-30
Completion
2007-04-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00740285 on ClinicalTrials.gov