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Effectiveness and Safety of Lidocaine for Scleroderma

NCT ID: NCT00740285

Last Updated: 2008-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2007-04-30

Brief Summary

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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

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Conditions

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Scleroderma

Keywords

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scleroderma scleroderma - limited or diffuse types lidocaine effectiveness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

Lidocaine 2% without vessel constrictor

Intervention Type DRUG

* 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

2

Group Type PLACEBO_COMPARATOR

Placebo - physiological solution 0,9%

Intervention Type OTHER

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

Interventions

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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

Intervention Type DRUG

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of São Paulo

OTHER

Sponsor Role lead

Principal Investigators

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Rachel Riera, MD

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal de São Paulo

Virginia FM Trevisani, PhD

Role: STUDY_CHAIR

Universidade Federal de São Paulo

Alexandre WS Silva, PhD

Role: STUDY_DIRECTOR

Universidade Federal de São Paulo

Locations

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Universidade Federal de São Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type BACKGROUND
PMID: 8923589 (View on PubMed)

Other Identifiers

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390/00

Identifier Type: -

Identifier Source: org_study_id