Efficacy and safety of eltenac gel in the treatment of knee osteoarthritis

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Efficacy and safety of eltenac gel in the treatment of knee osteoarthritis

B. Ottillinger, B. Gömör, B. A. Michel, K. Pavelka, W. Beck, U. Elsasser

p 273-280, Volume 9, Number 3, April 2001

Abstract

Objective A double-blind, placebo-controlled dose-finding study was performed in

237 patients with predominantly unilateral knee osteoarthritis (OA) evaluating

efficacy and safety of a new topical NSAID.

Design The patients applied 3 g tid eltenac gel 0.1%, 0.3%, 1% or placebo gel

over a period of 4 weeks. The patients were supplied with paracetamol tablets as

an escape analgesic.

Primary efficacy end-point was mean global pain in the week preceding the

examinations, evaluated on a visual analog scale (VAS).

Secondary criteria were Lequesne's score ISK, Jezek score, muscle strength and

dolorimeter measurements, walking time, clinical examination results of the knee

joint and patient's and investigator's overall efficacy estimates.

Results The graphical depiction of VAS and ISK suggested a dose-related

efficacy, but the pre-planned statistical analysis did not show significant

differences between treatments.

In the patient subgroup with a higher degree of baseline severity of knee OA the

ISK showed significant and relevant advantages of eltenac gel 1% to placebo at

different examination times.

Two patients each of the eltenac gel 1% group and the placebo group showed local

intolerance reactions which subsided spontaneously.

Conclusion This study did not provide confirmatory proof of an efficacy of

topical eltenac in patients with knee OA. Methodological pitfalls and possible

responder subgroups are described. Despite the difficulties, dose-finding

studies seem to be feasible even with topical NSAIDs. Copyright 2000

OsteoArthritis Research Society International