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

Primary Purpose

Osteoarthritis of the Knee

Status
Completed
Phase
Phase 4
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Glucosamine and chondroitin sulfate
glucosamine and chondroitin sulfate plus Prednisolone
Glucosamine and Chondroitin sulfate plus Chloroquine
Glucosamine,Chondroitin sulfate,Prednisolone,Chloroquine
Sponsored by
Ardabil University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis of the Knee focused on measuring Osteoarthritis of the Knee, Glucosamine Chondroitin sulfate, Prednisolone, Chloroquine

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • ArdabiUMS Clinic of Rheumatology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Glucosamine and chondroitin sulfate

P :glucosa, chondroitin, Prednis

Glucosa, Chondroitin, Chloroquine

Glucosa, Chondro, Prednis,Chloroq

Arm Description

in this group patients will receive Glucosamine and chondroitin sulfate oral dietary supplementation

in this group patients will receive glucosamine and chondroitin sulfate plus Prednisolone oral administration

in this group pateints will orally receive Glucosamine and Chondroitin sulfate plus Chloroquine.

in this group patients will receive Glucosamine and Chondroitin sulfate plus Prednisolone and Chloroquine

Outcomes

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)
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 Measures

The secondary measure will be changes in stiffness
The secondary measure will be changes in stiffness
The secondary measure will be changes in stiffness

Full Information

First Posted
December 8, 2008
Last Updated
April 29, 2010
Sponsor
Ardabil University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00805519
Brief Title
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

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ardabil University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Knee
Keywords
Osteoarthritis of the Knee, Glucosamine Chondroitin sulfate, Prednisolone, Chloroquine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
230 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Glucosamine and chondroitin sulfate
Arm Type
Active Comparator
Arm Description
in this group patients will receive Glucosamine and chondroitin sulfate oral dietary supplementation
Arm Title
P :glucosa, chondroitin, Prednis
Arm Type
Experimental
Arm Description
in this group patients will receive glucosamine and chondroitin sulfate plus Prednisolone oral administration
Arm Title
Glucosa, Chondroitin, Chloroquine
Arm Type
Experimental
Arm Description
in this group pateints will orally receive Glucosamine and Chondroitin sulfate plus Chloroquine.
Arm Title
Glucosa, Chondro, Prednis,Chloroq
Arm Type
Experimental
Arm Description
in this group patients will receive Glucosamine and Chondroitin sulfate plus Prednisolone and Chloroquine
Intervention Type
Drug
Intervention Name(s)
Glucosamine and chondroitin sulfate
Intervention Description
In this arm fixed dose glucosamine (400 mg) and chondroitin sulfate (500 mg)combination will be administrated to the patients, daily.
Intervention Type
Drug
Intervention Name(s)
glucosamine and chondroitin sulfate plus Prednisolone
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Glucosamine and Chondroitin sulfate plus Chloroquine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Glucosamine,Chondroitin sulfate,Prednisolone,Chloroquine
Intervention Description
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 Outcome Measure Information:
Title
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
Title
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
Title
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 Outcome Measure Information:
Title
The secondary measure will be changes in stiffness
Time Frame
the outcome is assessed at baseline visit
Title
The secondary measure will be changes in stiffness
Time Frame
the outcome is assessed at 6 weeks after baseline visit
Title
The secondary measure will be changes in stiffness
Time Frame
the outcome is assessed at 12 weeks after baseline visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shahab Bohlooli, PhD
Organizational Affiliation
Pharmacology Dept, Faculty of Medicine, ArdabilUMS
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marina Jastan, MD
Organizational Affiliation
Rheomatology clinic, Faculty of Medicine, ArdabilUMS
Official's Role
Principal Investigator
Facility Information:
Facility Name
ArdabiUMS Clinic of Rheumatology
City
Ardabil
ZIP/Postal Code
56197
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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