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

Nucitec

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Osteoarthritis

Treatments: Drug: kondrium; Drug: kondrium f; Drug: methyl prednisolone (corticosteroid)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00977444

PEE-002-2007

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 114 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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114 participants in 3 patient groups

kondrium

Experimental group

Description:

intraarticular injections once month

Treatment:

Drug: kondrium

kondrium f

Experimental group

Treatment:

Drug: kondrium f

corticosteroid

Active Comparator group

Description:

intraarticular injections once month

Treatment:

Drug: methyl prednisolone (corticosteroid)