NCT00700297

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
169

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2002

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2002

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

June 17, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 18, 2008

Completed
Last Updated

June 18, 2008

Status Verified

May 1, 2008

Enrollment Period

3.2 years

First QC Date

June 17, 2008

Last Update Submit

June 17, 2008

Conditions

Behcet's Syndrome

Keywords

Oral aphthosisGenital aphthosisPsuedofolliculitisErythem nodusomJoint manifestationsColchicine

Outcome Measures

Primary Outcomes (1)

  • Iranian Behcet's Disease Dynamic Activity Measurement (IBDDAM)

    8 months

Secondary Outcomes (5)

  • Oral Aphthosis

    8 months

  • Genital Aphthosis

    8 months

  • Psuedofolliculitis

    8 months

  • Erythem Nodusom

    8 months

  • Joint Manifestations

    8 months

Study Arms (2)

Colchicine

ACTIVE COMPARATOR

Patients who received Colchicine and went on placebo after 4 months

Drug: Colchicine

Placebo

PLACEBO COMPARATOR

Patients who received placebo and went on Colchicine after 4 months

Drug: Placebo

Interventions

ColchicineDRUG

100 mg Colchicine per day for 4 months

Also known as: Modacine
Colchicine
PlaceboDRUG

One tablet placebo per day for 4 months

Placebo

Eligibility Criteria

Age14 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • major organ involvement
  • Hypersensitivity reaction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rheumatology research Center, Tehran UMS

Tehran, Tehran Province, 14114, Iran

Location

Related Publications (2)

  • Davatchi F, Shams H, Rezaipoor M, Sadeghi-Abdollahi B, Shahram F, Nadji A, Chams-Davatchi C, Akhlaghi M, Faezi T, Naderi N. Rituximab in intractable ocular lesions of Behcet's disease; randomized single-blind control study (pilot study). Int J Rheum Dis. 2010 Aug;13(3):246-52. doi: 10.1111/j.1756-185X.2010.01546.x.

    PMID: 20704622DERIVED

  • Davatchi F, Sadeghi Abdollahi B, Tehrani Banihashemi A, Shahram F, Nadji A, Shams H, Chams-Davatchi C. Colchicine versus placebo in Behcet's disease: randomized, double-blind, controlled crossover trial. Mod Rheumatol. 2009;19(5):542-9. doi: 10.1007/s10165-009-0200-2. Epub 2009 Jul 14.

    PMID: 19597921DERIVED

MeSH Terms

Conditions

Behcet Syndrome

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesUveitis, AnteriorPanuveitisUveitisUveal DiseasesEye DiseasesVasculitisVascular DiseasesCardiovascular DiseasesHereditary Autoinflammatory DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin Diseases, GeneticSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, Vascular

Intervention Hierarchy (Ancestors)

AlkaloidsHeterocyclic Compounds

Study Officials

  • Fereydoun Davatchi, Professor

    Rheumatology Research Center, Tehran University for Medical Sciences

    STUDY CHAIR

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 17, 2008

First Posted

June 18, 2008

Study Start

August 1, 2002

Primary Completion

October 1, 2005

Study Completion

May 1, 2006

Last Updated

June 18, 2008

Record last verified: 2008-05

Locations

IR(1)