Trial record 6 of 61 for:    "Behcet Syndrome"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00700297
Recruitment Status : Completed
First Posted : June 18, 2008
Last Update Posted : June 18, 2008
Information provided by:
Tehran University of Medical Sciences

Brief 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.

Condition or disease Intervention/treatment Phase
Behcet's Syndrome Drug: Colchicine Drug: Placebo Phase 2

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  (Clinical Trial)
Actual Enrollment : 169 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double Blind Cross Over Clinical Trial to Determine Colchicine Efficacy in Behcet`s Disease
Study Start Date : August 2002
Actual Primary Completion Date : October 2005
Actual Study Completion Date : May 2006

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 Name: 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

Primary Outcome Measures :
  1. Iranian Behcet's Disease Dynamic Activity Measurement (IBDDAM) [ Time Frame: 8 months ]

Secondary Outcome Measures :
  1. Oral Aphthosis [ Time Frame: 8 months ]
  2. Genital Aphthosis [ Time Frame: 8 months ]
  3. Psuedofolliculitis [ Time Frame: 8 months ]
  4. Erythem Nodusom [ Time Frame: 8 months ]
  5. Joint Manifestations [ Time Frame: 8 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • major organ involvement
  • Hypersensitivity reaction

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00700297

Iran, Islamic Republic of
Rheumatology research Center, Tehran UMS
Tehran, Iran, Islamic Republic of, 14114
Sponsors and Collaborators
Tehran University of Medical Sciences
Study Chair: Fereydoun Davatchi, Professor Rheumatology Research Center, Tehran University for Medical Sciences
Principal Investigator: Bahar Sadeghi, MD 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 automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Fereydoun Davatchi, Head Rheumatology Research Center, Rheumatology Research Center, Tehran University for Medical Sciences Identifier: NCT00700297     History of Changes
Other Study ID Numbers: rrc-23
First Posted: June 18, 2008    Key Record Dates
Last Update Posted: June 18, 2008
Last Verified: May 2008

Keywords provided by Tehran University of Medical Sciences:
Oral aphthosis
Genital aphthosis
Erythem nodusom
Joint manifestations

Additional relevant MeSH terms:
Behcet Syndrome
Mouth Diseases
Stomatognathic Diseases
Uveitis, Anterior
Uveal Diseases
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Hereditary Autoinflammatory Diseases
Genetic Diseases, Inborn
Skin Diseases, Genetic
Skin Diseases
Skin Diseases, Vascular
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents