Effectiveness and Safety of Lidocaine for Scleroderma

Scleroderma Clinical Trial

Official title:

Effectiveness and Safety of Lidocaine for Scleroderma. Randomized Double-Blind Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00740285
• Other study ID #: 390/00
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: August 19, 2008
• Last updated: August 21, 2008
• Start date: April 2004
• Est. completion date: April 2007

Study information

• Verified date: August 2008
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: April 2007
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Scleroderma
• Scleroderma, Diffuse
• Scleroderma, Localized
• Scleroderma, Systemic

Intervention

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

Locations

Country	Name	City	State
Brazil	Universidade Federal de São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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 .

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin thickening evaluated by Skin Score		before, immediately after the intervention and 6 months later	No
Secondary	Safety - evaluated by the adverse effects during the intervention		immediately after the intervention	Yes
Secondary	Quality of Life evaluated by HAQ		before, immediately after the intervention and 6 months later	No
Secondary	Pressure at lower esophagus evaluated by esophagus manometry		before, immediately after the intervention and 6 months later	No
Secondary	Vessel alterations (as the number deletion/ectasia) evaluated by fingernail capillaroscopy		before, immediately after the intervention and 6 months later	No
Secondary	Subjective evaluation by patients		before, immediately after the intervention and 6 months later	No