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Colchicine Randomized Double-Blind Controlled Crossover Study in Behcet's Disease

NCT00700297 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 169

Last updated 2008-06-18

No results posted yet for this study

Summary

Colchicine was first used in Behcet's Disease (BD), in 1977. There are controversial reports of the efficacy of Colchicine in BD. For some experts the unresponsiveness of some patients could be explained by genetic difference between the Silk Road BD and sporadic BD from other parts of the world.

To test this hypothesis (the inefficacy of colchicine in the Silk Road BD), we designed a randomized double-blind controlled crossover study in Iran, which is in the middle of the Silk Road, and has the second highest prevalence of BD in the world.

Conditions

  • Behcet's Syndrome

Interventions

DRUG

Colchicine

100 mg Colchicine per day for 4 months

DRUG

Placebo

One tablet placebo per day for 4 months

Sponsors & Collaborators

  • Tehran University of Medical Sciences

    lead OTHER

Principal Investigators

  • Fereydoun Davatchi, Professor · Rheumatology Research Center, Tehran University for Medical Sciences

  • Bahar Sadeghi, MD · Rheumatology research Center, Tehran University for Medical Sciences

  • Arash Tehrani Banihashemi, MD, MPH · Rheumatology Research Center, Tehran University for Mrdical Sciences

  • Farhad Shahram, Professor · Rheumatology Research Center, Tehran University for Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
14 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-08-31
Primary Completion
2005-10-31
Completion
2006-05-31

Countries

  • Iran

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00700297 on ClinicalTrials.gov