Evaluation of a New Formulation Useful for the Osteoarthrosis Treatment (EFO)

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.

• Drug: kondrium
  intraarticular injections once month
  Other Name: kondrium
• Drug: kondrium f
  intraarticular injections once month
  Other Name: kondrium f
• Drug: methyl prednisolone (corticosteroid)
  intraarticular injections once month
  Other Name: corticosteroid

• Experimental: kondrium
  intraarticular injections once month
  Intervention: Drug: kondrium
• Experimental: kondrium f
  Intervention: Drug: kondrium f
• Active Comparator: corticosteroid
  intraarticular injections once month
  Intervention: Drug: methyl prednisolone (corticosteroid)

Inclusion Criteria:

• age > 40 years
• symptomatic evidence of OA in the knee for at least 1 year
• radiographic evidence of Kellgren and Lawrence grade II to IV OA of the knee
• no intra-articular injection of corticosteroids within the last 3 months

Exclusion Criteria:

• any history of adverse reaction to the study drugs
• current pregnancy status
• uncontrolled hypertension
• active infection
• undergone surgery/arthroscopy within three months
• diagnosis of radiographic OA of Kellgren and Lawrence grade I