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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	19 February 2015
Main ID:	NCT00700297
Date of registration:	17/06/2008
Prospective Registration:	No
Primary sponsor:	Tehran University of Medical Sciences
Public title:	Colchicine Randomized Double-Blind Controlled Crossover Study in Behcet's Disease
Scientific title:	A Double Blind Cross Over Clinical Trial to Determine Colchicine Efficacy in Behcet`s Disease
Date of first enrolment:	August 2002
Target sample size:	169
Recruitment status:	Completed
URL:	http://clinicaltrials.gov/show/NCT00700297
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
Phase:	Phase 2

Countries of recruitment
Iran, Islamic Republic of

Contacts

Name:	Farhad Shahram, Professor
Address:
Telephone:
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Affiliation:	Rheumatology Research Center, Tehran University for Medical Sciences

Name:	Arash Tehrani Banihashemi, MD, MPH
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Affiliation:	Rheumatology Research Center, Tehran University for Mrdical Sciences

Name:	Bahar Sadeghi, MD
Address:
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Affiliation:	Rheumatology research Center, Tehran University for Medical Sciences

Name:	Fereydoun Davatchi, Professor
Address:
Telephone:
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Affiliation:	Rheumatology Research Center, Tehran University for Medical Sciences

Key inclusion & exclusion criteria

Inclusion Criteria:

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

Exclusion Criteria:

- major organ involvement

- Hypersensitivity reaction

Age minimum: 14 Years
Age maximum: 60 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Behcet's Syndrome

Intervention(s)

Drug: Colchicine

Drug: Placebo

Primary Outcome(s)

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

Secondary Outcome(s)

Oral Aphthosis [Time Frame: 8 months]

Genital Aphthosis [Time Frame: 8 months]

Erythem Nodusom [Time Frame: 8 months]

Joint Manifestations [Time Frame: 8 months]

Psuedofolliculitis [Time Frame: 8 months]

Secondary ID(s)

rrc-23

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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