Efficacy and Safety of Prednisolone and Chloroquine Add on Therapy in Osteoarthritis of the Knee

Sponsor

Ardabil University of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT00805519

Collaborator

(none)

230

Enrollment

Location

Arms

13.9

Duration (Months)

16.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study was conducted to evaluate the efficacy and safety of prednisolone and chloroquine add on therapies to combined glucosamine, chondroitin sulfate in osteoarthritis of the knee which will be done in contrast to combined glucosamine sulfate and chondroitin.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis of the Knee	Drug: Glucosamine and chondroitin sulfate Drug: glucosamine and chondroitin sulfate plus Prednisolone Drug: Glucosamine and Chondroitin sulfate plus Chloroquine Drug: Glucosamine,Chondroitin sulfate,Prednisolone,Chloroquine	Phase 4

Detailed Description

Fixed dose glucosamine, chondroitin sulfate combination is a treatment to osteoarthritis with some controversy about efficacy. it seems that addition of other agents may improve efficacy and decrease the required dose and cost. common oral corticosteroids such as low dose prednisolone and chloroquine are candidate for such add on therapies. nevertheless, add on therapy may expose the patients to new side effects which should followed and addressed.

In this investigator blinded controlled trial, 240 patients with diagnosed osteoarthritis of knee will be enrolled to the study. the patients will randomly be assigned to one of four groups of G (glucosamine and chondroitin sulfate ), P (Glucosamine and Chondroitin sulfate plus Prednisolone), C (Glucosamine and Chondroitin sulfate plus Chloroquine) and PC (Glucosamine and Chondroitin sulfate plus Prednisolone and Chloroquine). each group will consist 60 patients. the investigator(s) will be blind to the groups and interventions.

Study Design

Study Type:

Interventional

Actual Enrollment :

230 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

Efficacy and Safety of Prednisolone and Chloroquine Add on Therapy in Osteoarthritis of the Knee Treated With Fixed Dose Combination of Glucosamine and Chondroitin Sulfate.

Study Start Date :

Feb 1, 2009

Actual Primary Completion Date :

Apr 1, 2010

Actual Study Completion Date :

Apr 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Glucosamine and chondroitin sulfate in this group patients will receive Glucosamine and chondroitin sulfate oral dietary supplementation	Drug: Glucosamine and chondroitin sulfate In this arm fixed dose glucosamine (400 mg) and chondroitin sulfate (500 mg)combination will be administrated to the patients, daily.
Experimental: P :glucosa, chondroitin, Prednis in this group patients will receive glucosamine and chondroitin sulfate plus Prednisolone oral administration	Drug: glucosamine and chondroitin sulfate plus Prednisolone In this arm fixed dose glucosamine (400 mg) and chondroitin sulfate (500 mg)combination will be administrated to the patients as baseline therapy, daily. also,the patients will receive Prednisolone 5 mg/day
Experimental: Glucosa, Chondroitin, Chloroquine in this group pateints will orally receive Glucosamine and Chondroitin sulfate plus Chloroquine.	Drug: Glucosamine and Chondroitin sulfate plus Chloroquine In this arm fixed dose glucosamine (400 mg) and chondroitin sulfate (500 mg)combination will be administrated to the patients as baseline therapy, daily. also,the patients will receive chloroquine 150 mg every two days.
Experimental: Glucosa, Chondro, Prednis,Chloroq in this group patients will receive Glucosamine and Chondroitin sulfate plus Prednisolone and Chloroquine	Drug: Glucosamine,Chondroitin sulfate,Prednisolone,Chloroquine In this arm fixed dose glucosamine (400 mg) and chondroitin sulfate (500 mg)combination will be administrated to the patients as baseline therapy, daily. also,the patients will receive prednisolone 5 mg/day and chloroquine 150 mg every two days.

Outcome Measures

Primary Outcome Measures

The primary outcome measures is defined as the change from baseline to final assessment of the study knee in the 3 core continuous variables pain and physical function, assessing using the WOMAC subscales, and patient global assessment (PGA) [Baseline]
The primary outcome measures is defined as the change from baseline to final assessment of the study knee in the 3 core continuous variables pain and physical function, assessing using the WOMAC subscales, and patient global assessment (PGA) [the outcome is assessed at 6 weeks after baseline visit]
The primary outcome measures is defined as the change from baseline to final assessment of the study knee in the 3 core continuous variables pain and physical function, assessing using the WOMAC subscales, and patient global assessment (PGA) [the outcome is assessed at 12 weeks after baseline visit]

Secondary Outcome Measures

The secondary measure will be changes in stiffness [the outcome is assessed at baseline visit]
The secondary measure will be changes in stiffness [the outcome is assessed at 6 weeks after baseline visit]
The secondary measure will be changes in stiffness [the outcome is assessed at 12 weeks after baseline visit]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

men and non-pregnant women, age 40-85 years with primary OA of at least one knee.

Exclusion Criteria:

secondary arthritis related to systemic inflammatory arthritis (including rheumatoid arthritis, psoriatic arthritis, post-infectious arthritis and metabolic arthritis, traumatic arthritis or surgical joint replacement)corticosteroid use:
oral corticosteroid within the previous 14 days
intramuscular corticosteroid within 30 days
intraarticular corticosteroid into the study knee within 90 days
intra-articular corticosteroid into any other joint within 30 days or
topical corticosteroid at the site of application within 14 days
ongoing use of prohibited medication including NSAID, other oral analgesic, muscle relaxant, or low-dose antidepressant for any chronic pain management
glucosamine or chondroitin within the previous six months
history of alcohol or drug abuse
lactation
concomitant skin disease at the application site
current application for disability benefits on the basis of knee osteoarthritis; fibromyalgia; other painful or disabling condition affecting the knee

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ArdabiUMS Clinic of Rheumatology	Ardabil		Iran, Islamic Republic of	56197

Sponsors and Collaborators

Ardabil University of Medical Sciences

Investigators

Principal Investigator: Shahab Bohlooli, PhD, Pharmacology Dept, Faculty of Medicine, ArdabilUMS
Principal Investigator: Marina Jastan, MD, Rheomatology clinic, Faculty of Medicine, ArdabilUMS