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

June 17, 2008 updated by: Tehran University of Medical Sciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

169

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • major organ involvement
  • Hypersensitivity reaction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Colchicine
Patients who received Colchicine and went on placebo after 4 months
Drug: Colchicine
100 mg Colchicine per day for 4 months
Other Names:
  • Modacine
Placebo Comparator: Placebo
Patients who received placebo and went on Colchicine after 4 months
Drug: Placebo
One tablet placebo per day for 4 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Iranian Behcet's Disease Dynamic Activity Measurement (IBDDAM)
Time Frame: 8 months
8 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Oral Aphthosis
Time Frame: 8 months
8 months
Genital Aphthosis
Time Frame: 8 months
8 months
Psuedofolliculitis
Time Frame: 8 months
8 months
Erythem Nodusom
Time Frame: 8 months
8 months
Joint Manifestations
Time Frame: 8 months
8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tehran University of Medical Sciences

Investigators

  • Principal Investigator: Bahar Sadeghi, MD, Rheumatology Research Center, Tehran University for Medical Sciences
  • Study Chair: Fereydoun Davatchi, Professor, Rheumatology Research Center, Tehran University for Medical Sciences
  • Principal Investigator: Arash Tehrani Banihashemi, MD, MPH, Rheumatology Research Center, Tehran University for Mrdical Sciences
  • Principal Investigator: Farhad Shahram, Professor, Rheumatology Research Center, Tehran University for Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2002

Primary Completion (Actual)

October 1, 2005

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

June 17, 2008

First Submitted That Met QC Criteria

June 17, 2008

First Posted (Estimate)

June 18, 2008

Study Record Updates

Last Update Posted (Estimate)

June 18, 2008

Last Update Submitted That Met QC Criteria

June 17, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • rrc-23

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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