Overview

Evaluation of the Evolution of Imaging Markers of Cartilage Degradation in Patients With Knee Osteoarthritis Receiving DROGLICAN

Status:
Unknown status
Trial end date:
2018-06-01
Target enrollment:
Participant gender:
Summary
A previous multicenter trial led by Bioiberica S.A. has confirmed the efficacy and safety of DROGLICAN for the treatment of osteoarthritis (OA) in patients with severe pain. The MOVES study was a phase IV, double blind, randomized and non-inferiority trial to compare the efficacy and safety of a fixed dose combination of glucosamine hydrochloride (GH) + chondroitin sulfate (CS) (DROGLICAN) versus celecoxib in patient with symptomatic knee OA with moderate to severe pain. This study concluded that both drugs reduced the WOMAC Pain subscale by 50% without significant difference between groups. Further, there was no difference in all secondary outcomes assessing patient's pain, functional capacity, stiffness, inflammation, joint swelling, effusion, and overall quality of life. This new exploratory trial is aimed to evaluate the beneficial effect of DROGLICAN on the good health of the cartilage of patients suffering of knee osteoarthritis as revealed by qualitative assessment of cartilage biochemical composition in vivo.
Phase:
Phase 4
Details
Lead Sponsor:
Bioiberica
Collaborator:
Artialis
Treatments:
Acetaminophen
Cyclooxygenase 2 Inhibitors