Trial record 14 of 34 for:    "Behcet disease" OR "Behcet Syndrome"

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

This study has been completed.
Sponsor:
Information provided by:
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00700297
First received: June 17, 2008
Last updated: NA
Last verified: May 2008
History: No changes posted
  Purpose

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 Intervention Phase
Behcet's Syndrome
Drug: Colchicine
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double Blind Cross Over Clinical Trial to Determine Colchicine Efficacy in Behcet`s Disease

Resource links provided by NLM:


Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • Iranian Behcet's Disease Dynamic Activity Measurement (IBDDAM) [ Time Frame: 8 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Oral Aphthosis [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Genital Aphthosis [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Psuedofolliculitis [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Erythem Nodusom [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Joint Manifestations [ Time Frame: 8 months ] [ Designated as safety issue: No ]

Enrollment: 169
Study Start Date: August 2002
Study Completion Date: May 2006
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   14 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • major organ involvement
  • Hypersensitivity reaction
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00700297

Locations
Iran, Islamic Republic of
Rheumatology research Center, Tehran UMS
Tehran, Iran, Islamic Republic of, 14114
Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
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
  More Information

No publications provided by Tehran University of Medical Sciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fereydoun Davatchi, Head Rheumatology Research Center, Rheumatology Research Center, Tehran University for Medical Sciences
ClinicalTrials.gov Identifier: NCT00700297     History of Changes
Other Study ID Numbers: rrc-23
Study First Received: June 17, 2008
Last Updated: June 17, 2008
Health Authority: Iran: Ethics Committee

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

Additional relevant MeSH terms:
Behcet Syndrome
Mouth Diseases
Stomatognathic Diseases
Uveitis, Anterior
Panuveitis
Uveitis
Uveal Diseases
Eye Diseases
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Skin Diseases, Vascular
Skin Diseases
Colchicine
Gout Suppressants
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 20, 2014