Evaluation of a New Formulation Useful for the Osteoarthrosis Treatment

• Status: Unknown status
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nucitec
• Collaborator: National Council of Science and Technology, Mexico
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

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