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

This study has been completed.
Sponsor:
Information provided by:
Ardabil University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00805519
First received: December 8, 2008
Last updated: April 29, 2010
Last verified: April 2010
  Purpose

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.


Condition Intervention Phase
Osteoarthritis of the Knee
Drug: Glucosamine and chondroitin sulfate
Drug: glucosamine and chondroitin sulfate plus Prednisolone
Drug: Glucosamine and Chondroitin sulfate plus Chloroquine
Drug: Glucosamine,Chondroitin sulfate,Prednisolone,Chloroquine
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Ardabil University of Medical Sciences:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The secondary measure will be changes in stiffness [ Time Frame: the outcome is assessed at baseline visit ] [ Designated as safety issue: No ]
  • The secondary measure will be changes in stiffness [ Time Frame: the outcome is assessed at 6 weeks after baseline visit ] [ Designated as safety issue: No ]
  • The secondary measure will be changes in stiffness [ Time Frame: the outcome is assessed at 12 weeks after baseline visit ] [ Designated as safety issue: No ]

Enrollment: 230
Study Start Date: February 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00805519

Locations
Iran, Islamic Republic of
ArdabiUMS Clinic of Rheumatology
Ardabil, Iran, Islamic Republic of, 56197
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Shahab Bohlooli, Pharmacology Dept., Faculty of Medicine, ArdabilUMS
ClinicalTrials.gov Identifier: NCT00805519     History of Changes
Other Study ID Numbers: 870919
Study First Received: December 8, 2008
Last Updated: April 29, 2010
Health Authority: Iran: Ministry of Health

Keywords provided by Ardabil University of Medical Sciences:
Osteoarthritis of the Knee
Glucosamine Chondroitin sulfate
Prednisolone
Chloroquine

Additional relevant MeSH terms:
Osteoarthritis, Knee
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Methylprednisolone acetate
Prednisolone acetate
Chloroquine diphosphate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Chloroquine
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents

ClinicalTrials.gov processed this record on September 16, 2014