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A randomized controlled trial to evaluate the slow acting symptom modifying effect of colchicine in patients with osteoarthritis of the knee

Protocol summary

Summary
Objective: Assessment of the impact of slow-release colchicine in modifying the symptoms of knee osteoarthritis in comparison with placebo, Design: Double-blind and single center randomized clinical trial in 81 patients with knee osteoarthritis, Major eligibility criteria: Patients are considered as idiopathic knee osteoarthritis based on American college of rheumatology criteria, Kellgren & Lawrence radiographic criteria, clinical examination, and laboratory tests. Setting, conduct, and interventions: After recording the demographic data and characteristics of knee osteoarthritis, patients receive full-dose naproxen (maximum 1 g daily, Modava pharmaceutical company) for 2 weeks prior to beginning of the treatment. Then patients will randomize to two groups, colchicine group (0.5mg/bid, Modava pharmaceutical company) and placebo. Intervention will conduct for 4 months. All patients will continue previous treatment. Patients will follow up for using drugs and side effects by telephone. Main outcome measures: The baseline level of pain on visual analog scale (VAS), the rate of functional disability based on the Western Ontario and McMaster Universities arthritis index (modified WOMAC) and the health assessment questionnaire (ModHAQ) score will assess. These measurements will reassess in 3 th and 4th month of study.

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT2015071623240N1
Registration date: 2015-09-21, 1394/06/30
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-09-21, 1394/06/30
Registrant information
Name
Maryam Alsadat Mousavi
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4444 5366
Email address
ms.mousavi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2012-03-20, 1391/01/01
Expected recruitment end date
2012-09-20, 1391/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A randomized controlled trial to evaluate the slow acting symptom modifying effect of colchicine in patients with osteoarthritis of the knee
Public title
Effect of colchicine in osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1. American college of rheumatology (ACR) criteria and radiographic Kellgren & Lawrence criteria for osteoarthritis; 2. Knee osteoarthritis; 3. Non existence of Calcium pyrophosphate dihydrate crystal deposition disease (CPPD) arthritis in other joints; 4. No History of gout and pseudo-gout; 5. No History of inflammatory diseases according to laboratory; 6. Non existence of liver, kidney, cardiovascular diseases, cardiomyopathy, moderate to severe neouropathy, GI problems, fibromyalgia, infection; 7. No History of knee joint replacement; 8. No concurrent use of drug interfering with colchicine; 9. No existence of these laboratory tests: White blood cells <3500/mm3 Hemoglobin <10 mg/dl Creatinine >1.3 mg/dl Amino transferase >45 IU uric acid >6.5 mg/dl 10. At least 2 months after intra-articular corticosteroids and 3 months after intra-articular hyaluronic acid; 11. Using 2 weeks naproxen; 12. At least 4-6 months after use of glucoseamine, chondroitine sulfate or methylsulfonylmethane (MSM); 13. No contra-indication of colchicine; 14. Co-operation. Exclusion criteria: 1. No use of drugs according to the study protocol; 2. Severe side effect of colchicine or placebo; 3. Aggravation of knee pain; 4. Using analgesics due to other problems; 5. Knee trauma or any other problems interfering with drug use in knee osteoarthritis; 6. Loss of follow-up.
Age
From 35 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 81
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Table of random numbers

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Next to Ayatollah Taleghani Hospital, Shahid Arabi St., Yemen St., Shahid Chamran Highway
City
Tehran
Postal code
Approval date
2012-03-11, 1390/12/21
Ethics committee reference number
in 115th session

Health conditions studied

1

Description of health condition studied
Knee osteorathritis
ICD-10 code
M 19.9
ICD-10 code description
Arthrosis, unspecified

Primary outcomes

1

Description
Health Assessment
Timepoint
3rd and 4th Months
Method of measurement
modified health assessment questionnaire (modHAQ)

2

Description
Knee pain
Timepoint
3rd and 4th Months
Method of measurement
Visual Analog Scale (VAS)

3

Description
Functional disability
Timepoint
3rd and 4th Months
Method of measurement
modified Western Ontario and McMaster Universities arthritis (modified WOMAC) index

Secondary outcomes

empty

Intervention groups

1

Description
Patients receive full-dose naproxen (maximum 1 g daily, Modava pharmaceutical company) for 2 weeks prior to beginning of the treatment and then they give placebo.
Category
Placebo

2

Description
Patients receive full-dose naproxen (maximum 1 g daily, Modava pharmaceutical company) for 2 weeks prior to beginning of the treatment and then they give colchicine 0.5mg/bid (Modava pharmaceutical company).
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Maryam Alsadat Mousavi
Street address
Imam Hossein Hospital, Madani Street
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Investigator
Full name of responsible person
Dr Maryam Alsadat Mousavi
Street address
Next to Ayatollah Taleghani Hospital, Shahid Arabi Street, Yemen Street, Shahid Chamran Highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Investigator
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Maryam Alsadat Mousavi
Position
Medical Specialist
Other areas of specialty/work
Street address
Next to Ayatollah Taleghani Hospital, Shahid Arabi Street, Yemen Street, Shahid Chamran Highway
City
Tehran
Postal code
Phone
+98 21 4444 5366
Fax
Email
ms.mousavi@sbmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Maryam Alsadat Mousavi
Position
Medical Specialist
Other areas of specialty/work
Street address
Next to Ayatollah Taleghani Hospital, Shahid Arabi Street, Yemen Street, Shahid Chamran Highway
City
Tehran
Postal code
Phone
+98 21 4444 5366
Fax
Email
ms.mousavi@sbmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Maryam Alsadat Mousavi
Position
Medical Specialist
Other areas of specialty/work
Street address
Next to Ayatollah Taleghani Hospital, Shahid Arabi Street, Yemen Street, Shahid Chamran Highway
City
Tehran
Postal code
Phone
+98 21 4444 5366
Fax
Email
ms.mousavi@sbmu.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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