Colchicine Randomized Double-Blind Controlled Crossover Study in Behcet's Disease
NCT ID: NCT00700297
Last Updated: 2008-06-18
Study Results
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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COMPLETED
PHASE2
169 participants
INTERVENTIONAL
2002-08-31
2006-05-31
Brief Summary
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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.
Detailed Description
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The entry criteria was: age between 14 and 60 years, confirmed diagnosis of Behcet's Disease, absence of major organ involvement (eye, brain, lung, and cardio-vascular involvement), having at least one active symptom, and no treatment for at least one month. Patients were explained the study design and they gave a signed written consent. During the two phases of study, if a major organ involvement appeared, the patient was moved out of the study. All patients fulfilled the new International Criteria for Behcet's Disease.
Method: patients were randomized at the study entry to take either colchicine or placebo. At 4 months, they were crossed over. Those who were taking colchicine went on placebo and those on placebo went on colchicine. Each patient tried therefore, both colchicine and placebo. The primary outcome was the effect of colchicine on the disease activity index, the IBDDAM (16-17). To calculate the overall IBDDAM of the baseline, the IBDDAM of the last 12 months (prior to the study) of each manifestation was calculated and added together. The overall disease activity index was then divided to the number of months (12 months) to have the mean activity index per month. IBDDAM was then measured every 2 months (in the middle and at the end, in each arm of the study). The total IBBDAM of the 4 months was then divided by 4 to have the mean activity index per month. The secondary outcome was to see how the individual symptoms responded to colchicine (IBDDAM of each manifestation).
Statistical analysis: The analysis was done by the intention to treat method. As the difference between IBDDAM before and after treatment had normal distribution Student T test for paired samples were used to evaluate the outcome in the colchicine and the placebo group. As the Levene's test showed the homogeneity of variance, ANOVA (one way) was used to test the effect of treatment (colchicine and placebo) and gender on patients' outcome. The dependent variable was the difference between IBDDAM (before and after the treatment). The independent variables were the treatment, and the gender. SPSS 15 was used for all statistical calculations.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Colchicine
Patients who received Colchicine and went on placebo after 4 months
Colchicine
100 mg Colchicine per day for 4 months
Placebo
Patients who received placebo and went on Colchicine after 4 months
Placebo
One tablet placebo per day for 4 months
Interventions
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Colchicine
100 mg Colchicine per day for 4 months
Placebo
One tablet placebo per day for 4 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Hypersensitivity reaction
14 Years
60 Years
ALL
No
Sponsors
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Tehran University of Medical Sciences
OTHER
Responsible Party
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Rheumatology Research Center, Tehran University for Medical Sciences
Principal Investigators
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Fereydoun Davatchi, Professor
Role: STUDY_CHAIR
Rheumatology Research Center, Tehran University for Medical Sciences
Bahar Sadeghi, MD
Role: PRINCIPAL_INVESTIGATOR
Rheumatology research Center, Tehran University for Medical Sciences
Arash Tehrani Banihashemi, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Rheumatology Research Center, Tehran University for Mrdical Sciences
Farhad Shahram, Professor
Role: PRINCIPAL_INVESTIGATOR
Rheumatology Research Center, Tehran University for Medical Sciences
Locations
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Rheumatology research Center, Tehran UMS
Tehran, Tehran Province, Iran
Countries
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References
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Davatchi F, Shams H, Rezaipoor M, Sadeghi-Abdollahi B, Shahram F, Nadji A, Chams-Davatchi C, Akhlaghi M, Faezi T, Naderi N. Rituximab in intractable ocular lesions of Behcet's disease; randomized single-blind control study (pilot study). Int J Rheum Dis. 2010 Aug;13(3):246-52. doi: 10.1111/j.1756-185X.2010.01546.x.
Davatchi F, Sadeghi Abdollahi B, Tehrani Banihashemi A, Shahram F, Nadji A, Shams H, Chams-Davatchi C. Colchicine versus placebo in Behcet's disease: randomized, double-blind, controlled crossover trial. Mod Rheumatol. 2009;19(5):542-9. doi: 10.1007/s10165-009-0200-2. Epub 2009 Jul 14.
Other Identifiers
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rrc-23
Identifier Type: -
Identifier Source: org_study_id