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

Bioiberica

Status and phase: Unknown; Phase 4

Conditions: Knee Osteoarthritis

Treatments: Drug: Placebo; Drug: Chondroitin sulphate (Condrosan®)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01226615

CS/IV-RMF-01

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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64 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Chondroitin sulphate

Treatment:

Drug: Chondroitin sulphate (Condrosan®)

2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo