Effectiveness and Safety of Lidocaine for Scleroderma

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

April 30, 2004

Primary Completion Date

April 30, 2006

Study Completion Date

April 30, 2007

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

Trial Locations (1)

04039-001

Universidade Federal de São Paulo, São Paulo

All Listed Sponsors
lead

Federal University of São Paulo

OTHER

NCT00740285 - Effectiveness and Safety of Lidocaine for Scleroderma | Biotech Hunter | Biotech Hunter