Status:
UNKNOWN
Assessment of the Effects of Chondroitin Sulphate in Patients With Knee Osteoarthritis With Functional Magnetic Resonance Imaging (fMRI)
Lead Sponsor:
Bioiberica
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
40-75 years
Phase:
PHASE4
Brief Summary
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 rela...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT01226615
Start Date
October 1 2010
End Date
December 1 2012
Last Update
October 2 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital del Mar
Barcelona, Barcelona, Spain