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

Osteoarthritis of the Knee Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00805519
• Other study ID #: 870919
• Status: Completed
• Phase: Phase 4
• First received: December 8, 2008
• Last updated: April 29, 2010
• Start date: February 2009
• Est. completion date: April 2010

Study information

• Verified date: April 2010
• Source: Ardabil University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

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.
• 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
• 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.
• 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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	ArdabiUMS Clinic of Rheumatology	Ardabil

Sponsors (1)

Lead Sponsor	Collaborator
Ardabil University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Secondary	The secondary measure will be changes in stiffness		the outcome is assessed at baseline visit	No
Secondary	The secondary measure will be changes in stiffness		the outcome is assessed at 6 weeks after baseline visit	No
Secondary	The secondary measure will be changes in stiffness		the outcome is assessed at 12 weeks after baseline visit	No