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

April 29, 2010 updated by: Ardabil University of Medical Sciences

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

230

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
Time Frame: Baseline
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)
Time Frame: the outcome is assessed at 6 weeks after baseline visit
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)
Time Frame: the outcome is assessed at 12 weeks after baseline visit
the outcome is assessed at 12 weeks after baseline visit

Secondary Outcome Measures

Outcome Measure
Time Frame
The secondary measure will be changes in stiffness
Time Frame: the outcome is assessed at baseline visit
the outcome is assessed at baseline visit
The secondary measure will be changes in stiffness
Time Frame: the outcome is assessed at 6 weeks after baseline visit
the outcome is assessed at 6 weeks after baseline visit
The secondary measure will be changes in stiffness
Time Frame: the outcome is assessed at 12 weeks after baseline visit
the outcome is assessed at 12 weeks after baseline visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

December 8, 2008

First Submitted That Met QC Criteria

December 8, 2008

First Posted (Estimate)

December 9, 2008

Study Record Updates

Last Update Posted (Estimate)

April 30, 2010

Last Update Submitted That Met QC Criteria

April 29, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 870919

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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