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

Behcet's Syndrome Clinical Trial

Official title:

A Double Blind Cross Over Clinical Trial to Determine Colchicine Efficacy in Behcet`s Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00700297
• Other study ID #: rrc-23
• Status: Completed
• Phase: Phase 2
• First received: June 17, 2008
• Last updated: June 17, 2008
• Start date: August 2002
• Est. completion date: May 2006

Study information

• Verified date: May 2008
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

Patients: They were selected as consecutive patients.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: May 2006
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patient's who fulfilled the International Criteria for Behcet's Disease.

Exclusion Criteria:

• major organ involvement

• Hypersensitivity reaction

Study Design

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

Related Conditions & MeSH terms

• Behcet Syndrome
• Behcet's Syndrome

Intervention

Drug:
• Colchicine
100 mg Colchicine per day for 4 months
• Placebo
One tablet placebo per day for 4 months

Locations

Country	Name	City	State
Iran, Islamic Republic of	Rheumatology research Center, Tehran UMS	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Iranian Behcet's Disease Dynamic Activity Measurement (IBDDAM)		8 months	No
Secondary	Oral Aphthosis		8 months	No
Secondary	Genital Aphthosis		8 months	No
Secondary	Psuedofolliculitis		8 months	No
Secondary	Erythem Nodusom		8 months	No
Secondary	Joint Manifestations		8 months	No