Clinical trial NCT00805519: Efficacy and Safety of Prednisolone and Chloroquine Add on Therapy in Osteoarthritis of the Knee
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis of the Knee
Keywords: Osteoarthritis of the Knee
Glucosamine Chondroitin sulfate
Prednisolone
Chloroquine
Lead sponsor: Ardabil University of Medical Sciences
Sponsor class: OTHER
First posted: 2008-12-09
Enrollment: 230
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: Baseline
measure: 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)
timeFrame: the outcome is assessed at 6 weeks after baseline visit
measure: 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)
timeFrame: the outcome is assessed at 12 weeks after baseline visit
Secondary outcomes:
measure: The secondary measure will be changes in stiffness
timeFrame: the outcome is assessed at baseline visit
measure: The secondary measure will be changes in stiffness
timeFrame: the outcome is assessed at 6 weeks after baseline visit
measure: The secondary measure will be changes in stiffness
timeFrame: the outcome is assessed at 12 weeks after baseline visit
Other outcomes:
Locations:
city: Ardabil
country: Iran, Islamic Republic of
facility: ArdabiUMS Clinic of Rheumatology
Study officials:
affiliation: Pharmacology Dept, Faculty of Medicine, ArdabilUMS
name: Shahab Bohlooli, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rheomatology clinic, Faculty of Medicine, ArdabilUMS
name: Marina Jastan, MD
role: PRINCIPAL_INVESTIGATOR
References: