Osteoarthritis Clinical Trial
Official title:
Evaluation of a New Formulation Useful for the Osteoarthrosis Treatment
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.
The WOMAC osteoarthritis index is a validated, multidimensional, disease specific, health
status measure. It probes clinically important patient relevant symptoms in the areas of
pain, stiffness and physical function in patients with hip and/or knee osteoarthritis. It
consists of 24 questions in three separated subscales (5 questions on pain subscale, 17
questions on physical function subscales and 2 questions on stiffness subscale), each scored
in analog scale from 0 to 10 points (0 representing no pain, 10 representing extreme pain).
Each subscale score was weighed 10 points, thus 30 was the maximum punctuation for WOMAC
total score.
The Lequesne index is a 10-question interview-style survey given to patients with
osteoarthritis of the knee. It has 5 questions pertaining to pain or discomfort, 1 question
dealing with maximum distance walked, and 4 questions about daily activities. The total
questionnaire is scored on a 0 to 24 scale, with lower scores meaning less functional
impairment.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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