Assessment of the Effects of Chondroitin Sulphate in Patients With Knee Osteoarthritis With Functional Magnetic Resonance Imaging (fMRI)

Randomized, Double-blind, Placebo-controlled Study to Asses the Effect of Chondroitin Sulphate in Patients With Knee Osteoarthritis by Functional Magnetic Resonance Imaging

The main purposes of this study are:

• to determine the effects of chondroitin sulphate on brain response to pain assessed through fMRI in patients with knee osteoarthritis.
• to investigate the relationship between treatment response detected by fMRI and the results of the different parameters of clinical assessment.

Study Overview

• Status: Unknown
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Drug: Chondroitin sulphate (Condrosan®); Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain
    • Hospital Del Mar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Primary knee OA according to ACR criteria
• OA of radiological stages 2 to 3 according to Kellgren-Lawrence
• Estable knee pain during the last months before to start the clinical trial
• Patients with pain as the VAS≥50mm at baseline

Exclusion Criteria:

• Patients with skin conditions that could interfere in the clinical trial evaluation
• Pregnant or breastfeeding woman
• Patients with a history of alcoholism or other drug abuse
• Patients with an uncontrolled active psychiatric disorder
• Patients with other inflammatory or systemic conditions affecting other joints
• Patients who suffer more intense pain in the joint in another location
• Patients unable to differentiate between symptoms caused by the knee in front of the joint study opposite
• OA of radiological stages 1 or 4 according to Kellgren-Lawrence
• Other bone and articular diseases such as chondrocalcinosis, Paget's disease, rheumatoid arthritis, aseptic osteonecrosis, gout, septic arthritis, ochronosis, acromegaly, hemochromatosis, Wilson's disease, osteochondromatosis
• Patients with contraindications to perform an MRI such as: certain tattoos, pacemakers, intracranial clips incompatible with MRI, in the heart valves, hearing aids and other types of implants are incompatible with MRI
• Known allergy to chondroitin sulphate
• Washout period for OA treatments before beginning the study

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 2; Placebo	Drug: Placebo; Two placebo capsules taken once a day for four months.
Experimental: 1; Chondroitin sulphate	Drug: Chondroitin sulphate (Condrosan®); 800mg (two capsules of 400mg each) taken once a day for four months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brain response to pain caused on arthritic knee selected by fMRI	Functional magnetic resonance imaging (fMRI) is particularly suited to investigating the effects of pharmacological agents on pain processing within the human central nervous system. The measures are based on the haemodynamic resonse to a neuronal event and constitute indirect measures of excitatory and inhibitory neuronal activity. The neuronal activation is associated with an increase of the oxygen extraction fraction from the capillaries and with an increase in regional cerebral blood flow. The measure which derived from blood oxygenation is called the BOLD effect.	4 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Assessment of the reduction of pain by Huskisson VAS	4 months
Determination of pain and functional capacity using the Lequesne Algofunctional Index	4 months
Use of rescue medication	4 months
Assessment of the quality of life of patients by SF-36 Health Questionaire	4 months

Collaborators and Investigators

• Sponsor: Bioiberica
• Investigators: Principal Investigator: Jesús Pujol, MD, Hospital Del Mar; Principal Investigator: Jordi Monfort, MD, Hospital Del Mar

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): October 1, 2011
• Study Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: October 8, 2010
• First Submitted That Met QC Criteria: October 21, 2010
• First Posted (Estimate): October 22, 2010

Study Record Updates

• Last Update Posted (Estimate): October 2, 2012
• Last Update Submitted That Met QC Criteria: October 1, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: Functional Magnetic Resonance Imaging; Knee osteoarthritis; Chondroitin sulphate
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: CS/IV-RMF-01