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Effectiveness and Safety of Lidocaine for Scleroderma

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
Recruitment Status : Completed
First Posted : August 22, 2008
Last Update Posted : August 22, 2008
Sponsor:
Information provided by:
Federal University of São Paulo

Tracking Information
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
 (submitted: August 21, 2008)
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
 (submitted: August 21, 2008)
  • Safety - evaluated by the adverse effects during the intervention [ Time Frame: immediately after the intervention ]
  • Quality of Life evaluated by HAQ [ Time Frame: before, immediately after the intervention and 6 months later ]
  • Pressure at lower esophagus evaluated by esophagus manometry [ Time Frame: before, immediately after the intervention and 6 months later ]
  • Vessel alterations (as the number deletion/ectasia) evaluated by fingernail capillaroscopy [ Time Frame: before, immediately after the intervention and 6 months later ]
  • Subjective evaluation by patients [ Time Frame: before, immediately after the intervention and 6 months later ]
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Scleroderma
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: Lidocaine 2% without vessel constrictor
  • Placebo Comparator: 2
    Intervention: Other: Placebo - physiological solution 0,9%
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 21, 2008)
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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
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
PRS Account Federal University of São Paulo
Verification Date August 2008

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