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NCT Number: NCT00805519

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

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.

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Key information

Conditions

Osteoarthritis of the Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

ArdabiUMS Clinic of Rheumatology

Ardabil, Ardabil Province, 56197, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glucosamine and chondroitin sulfate

Drug

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

Drug

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

Drug

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

Drug

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. The secondary measure will be changes in stiffness

    Time frame: the outcome is assessed at baseline visit

  2. The secondary measure will be changes in stiffness

    Time frame: the outcome is assessed at 6 weeks after baseline visit

  3. The secondary measure will be changes in stiffness

    Time frame: the outcome is assessed at 12 weeks after baseline visit

Sponsors and collaborators

Lead sponsor

Ardabil University of Medical Sciences

Other

Registry information

Official study 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.

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 9, 2008
Registry last updated
Apr 30, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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