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

NCT00805519 | Completed Phase 4 DMC

• 1 other identifier: 870919
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis of the Knee

Keywords

Osteoarthritis of the Knee; Glucosamine Chondroitin sulfate; Prednisolone; Chloroquine

Outcome Measures

Primary Outcomes (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)

  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)

  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)

  the outcome is assessed at 12 weeks after baseline visit

Secondary Outcomes (3)

• The secondary measure will be changes in stiffness

  the outcome is assessed at baseline visit

• The secondary measure will be changes in stiffness

  the outcome is assessed at 6 weeks after baseline visit

• The secondary measure will be changes in stiffness

  the outcome is assessed at 12 weeks after baseline visit

Study Arms (4)

Glucosamine and chondroitin sulfate

ACTIVE COMPARATOR

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

Drug: Glucosamine and chondroitin sulfate

P :glucosa, chondroitin, Prednis

EXPERIMENTAL

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

Drug: glucosamine and chondroitin sulfate plus Prednisolone

Glucosa, Chondroitin, Chloroquine

EXPERIMENTAL

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

Drug: Glucosamine and Chondroitin sulfate plus Chloroquine

Glucosa, Chondro, Prednis,Chloroq

EXPERIMENTAL

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

Drug: Glucosamine,Chondroitin sulfate,Prednisolone,Chloroquine

Interventions

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

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

P :glucosa, chondroitin, Prednis

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.

Glucosa, Chondroitin, Chloroquine

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.

Glucosa, Chondro, Prednis,Chloroq

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• men and non-pregnant women, age 40-85 years with primary OA of at least one knee.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ardabil University of Medical Sciences: lead

Study Sites (1)

ArdabiUMS Clinic of Rheumatology

Ardabil, Ardabil Province, 56197, Iran

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Glucosamine; Chondroitin Sulfates; Prednisolone; Chloroquine

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Hexosamines; Amino Sugars; Carbohydrates; Chondroitin; Glycosaminoglycans; Polysaccharides; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Shahab Bohlooli, PhD

  Pharmacology Dept, Faculty of Medicine, ArdabilUMS

  PRINCIPAL INVESTIGATOR

• Marina Jastan, MD

  Rheomatology clinic, Faculty of Medicine, ArdabilUMS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 8, 2008
• First Posted: December 9, 2008
• Study Start: February 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: April 30, 2010

Record last verified: 2010-04

Locations

IR (1)