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Effectiveness and Safety of Lidocaine for Scleroderma

Primary Purpose

Scleroderma

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Lidocaine 2% without vessel constrictor
Placebo - physiological solution 0,9%
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scleroderma focused on measuring scleroderma, scleroderma - limited or diffuse types, lidocaine, effectiveness

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universidade Federal de São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Skin thickening evaluated by Skin Score

Secondary Outcome Measures

Safety - evaluated by the adverse effects during the intervention
Quality of Life evaluated by HAQ
Pressure at lower esophagus evaluated by esophagus manometry
Vessel alterations (as the number deletion/ectasia) evaluated by fingernail capillaroscopy
Subjective evaluation by patients

Full Information

First Posted
August 19, 2008
Last Updated
August 21, 2008
Sponsor
Federal University of São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT00740285
Brief Title
Effectiveness and Safety of Lidocaine for Scleroderma
Official Title
Effectiveness and Safety of Lidocaine for Scleroderma. Randomized Double-Blind Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Federal University of São Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scleroderma
Keywords
scleroderma, scleroderma - limited or diffuse types, lidocaine, effectiveness

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Lidocaine 2% without vessel constrictor
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Placebo - physiological solution 0,9%
Intervention Description
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
Primary Outcome Measure Information:
Title
Skin thickening evaluated by Skin Score
Time Frame
before, immediately after the intervention and 6 months later
Secondary Outcome Measure Information:
Title
Safety - evaluated by the adverse effects during the intervention
Time Frame
immediately after the intervention
Title
Quality of Life evaluated by HAQ
Time Frame
before, immediately after the intervention and 6 months later
Title
Pressure at lower esophagus evaluated by esophagus manometry
Time Frame
before, immediately after the intervention and 6 months later
Title
Vessel alterations (as the number deletion/ectasia) evaluated by fingernail capillaroscopy
Time Frame
before, immediately after the intervention and 6 months later
Title
Subjective evaluation by patients
Time Frame
before, immediately after the intervention and 6 months later

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel Riera, MD
Organizational Affiliation
Universidade Federal de São Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Virginia FM Trevisani, PhD
Organizational Affiliation
Universidade Federal de São Paulo
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Alexandre WS Silva, PhD
Organizational Affiliation
Universidade Federal de São Paulo
Official's Role
Study Director
Facility Information:
Facility Name
Universidade Federal de São Paulo
City
São Paulo
ZIP/Postal Code
04039-001
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
8923589
Citation
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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Effectiveness and Safety of Lidocaine for Scleroderma

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