Efficacy and Safety of Prednisolone and Chloroquine Add on Therapy in Osteoarthritis of the Knee
Information source: Ardabil University of Medical Sciences
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoarthritis of the Knee
Intervention: Glucosamine and chondroitin sulfate (Drug); glucosamine and chondroitin sulfate plus Prednisolone (Drug); Glucosamine and Chondroitin sulfate plus Chloroquine (Drug); Glucosamine,Chondroitin sulfate,Prednisolone,Chloroquine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Ardabil University of Medical Sciences Official(s) and/or principal investigator(s): Shahab Bohlooli, PhD, Principal Investigator, Affiliation: Pharmacology Dept, Faculty of Medicine, ArdabilUMS Marina Jastan, MD, Principal Investigator, Affiliation: Rheomatology clinic, Faculty of Medicine, ArdabilUMS
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Primary outcome: 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 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 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)
Secondary outcome: The secondary measure will be changes in stiffnessThe secondary measure will be changes in stiffness The secondary measure will be changes in stiffness
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
Minimum age: 40 Years.
Maximum age: 85 Years.
Gender(s): Both.
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
Locations and Contacts
ArdabiUMS Clinic of Rheumatology, Ardabil 56197, Iran, Islamic Republic of
Additional Information
Starting date: February 2009
Last updated: April 29, 2010
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