Evaluation of a New Formulation Useful for the Osteoarthrosis Treatment
Status:
Unknown status
Trial end date:
2009-10-01
Target enrollment:
Participant gender:
Summary
Abstract
Kondrium, is a pharmaceutical composition for the treatment of osteoarthritis (OA). This
study was designed to evaluate the efficacy and safety of kondrium in the treatment of OA of
knee.
A 3 month, randomized, double-blind, active-controlled, parallel-group study will be carried
out. 117 patients with OA of the knee will be randomized to receive 1 intra-articular monthly
injection of 5 mL of one of the following: 75 mg/mL of Kondrium, 82.5 mg/mL of Kondriumf or 8
mg/mL of methylprednisolone once a month during 3 months. The primary efficacy variable will
be the change from baseline to final assessment in the Western Ontario and McMaster
University OA index (WOMAC subscale score for pain), and Lequesne´s functional index.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Nucitec
Collaborator:
National Council of Science and Technology, Mexico