This trial is active, not recruiting.

Condition knee osteoarthritis
Treatments chondroitin sulphate (condrosan®), placebo
Phase phase 4
Sponsor Bioiberica
Start date October 2010
End date October 2011
Trial size 64 participants
Trial identifier NCT01226615, CS/IV-RMF-01


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Chondroitin sulphate
chondroitin sulphate (condrosan®)
800mg (two capsules of 400mg each) taken once a day for four months
(Placebo Comparator)
Two placebo capsules taken once a day for four months.

Primary Outcomes

Brain response to pain caused on arthritic knee selected by fMRI
time frame: 4 months

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 40 years up to 75 years old.

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

Additional Information

Official title Randomized, Double-blind, Placebo-controlled Study to Asses the Effect of Chondroitin Sulphate in Patients With Knee Osteoarthritis by Functional Magnetic Resonance Imaging
Principal investigator Jordi Monfort, MD
Trial information was received from ClinicalTrials.gov and was last updated in October 2012.
Information provided to ClinicalTrials.gov by Bioiberica.