Titre du document / Document title

A double-blind comparison of piroxicam fast-dissolving dosage form and diclofenac enteric-coated tablets in the treatment of patients with acute musculoskeletal disorders

Auteur(s) / Author(s)

Multicenter Piroxicam FDDF European Study Group, EUROPE
AUVINET B. ⁽¹⁾ ; CRIELAARD J. M. ; MANTEUFFEL G. E. ; MÜLLER P. ;

Affiliation(s) du ou des auteurs / Author(s) Affiliation(s)

⁽¹⁾ Hôp. Haut Rocher, rheumatology unit, 53024 Laval, FRANCE

Résumé / Abstract

A double-blind, double-dummy, parallel-group, multicenter study conducted by 24 investigators in five European countries randomly assigned 224 adult patients with acute musculoskeletal disorders (sprains or tendinitis) to once-daily piroxicam fast-dissolving dosage form (FDDF) (108 patients received 40 mg on the first 2 days and 20 mg thereafter) or to diclofenac enteric-coated (EC) tablets (116 patients received 50 mg with meals three times daily for 2 days and then twice daily for the remainder of the treatment). A total of 104 piroxicam FDDF-treated patients and 109 diclofenac EC-treated patients were assessable for efficacy. Statistically significant (P < 0.001) improvements from baseline were observed at each follow-up visit in both treatment groups for all efficacy parameters measured, including pain on movement, change in overall symptoms since the last visit, tenderness on palpation, ability to resume a specific activity, and restriction of active motion. Pain relief was noted 0.5 hour after the first dose and was maintained throughout the 24-hour dosing period in both treatment groups. In the opinion of both the investigators and patients, the overall impression of the efficacy of both study drugs was considered to be either good or excellent in the majority of cases of sprain injury. For patients with tendinitis, however, the overall impression of the efficacy of piroxicam FDDF was considered by both investigators and patients to be significantly better (P = 0.009 and P = 0.02, respectively) than that of diclofenac EC. The incidence of drug-related adverse events was 12% (13/108) for piroxicam FDDF and 18% (21/116) for diclofenac EC. Adverse events related or possibly related to the study treatment forced the withdrawal of 7 patients (7%) in the piroxicam FDDF group and 6 (5%) in the diclofenac EC group. These results show the newly developed dosage form, piroxicam FDDF, to be comparable to diclofenac EC in efficacy and tolerability for the treatment of patients with acute musculoskeletal disorders.

Revue / Journal Title

Current therapeutic research   ISSN 0011-393X   CODEN CTCEA9 

Source / Source

1995, vol. 56, n^o11, pp. 1142-1153 (7 ref.)

Langue / Language

Anglais

Editeur / Publisher

Excerpta medica, Belle Mead, NJ, ETATS-UNIS  (1959) (Revue)

Mots-clés anglais / English Keywords

Comparative study ; Sprain ; Acute ; Tendinitis ; Chemotherapy ; Treatment ; Enteric coating ; Tablet ; Double blind study ; Multicenter study ; Adult ; Oral administration ; Non steroidal antiinflammatory agent ; Europe ; Human ; Diseases of the osteoarticular system ; Trauma ; Juxtaarticular disease ;

Mots-clés français / French Keywords

Piroxicam ; Diclofénac ; Etude comparative ; Entorse ; Aigu ; Tendinite ; Chimiothérapie ; Traitement ; Enrobage entérique ; Comprimé ; Etude double insu ; Etude multicentrique ; Adulte ; Voie orale ; Antiinflammatoire non stéroïde ; Europe ; Oxicam dérivé ; Arylacétique acide dérivé ; Homme ; Système ostéoarticulaire pathologie ; Traumatisme ; Juxtaarticulaire pathologie ;

Mots-clés espagnols / Spanish Keywords

Estudio comparativo ; Esguince ; Agudo ; Tendinitis ; Quimioterapia ; Tratamiento ; Cubierta entérica ; Tableta ; Estudio doble ciego ; Estudio multicéntrico ; Adulto ; Vía oral ; Antiinflamatorio no esteroide ; Europa ; Hombre ; Sistema osteoarticular patología ; Traumatismo ; Yuxtaarticular patología ;

Localisation / Location

INIST-CNRS, Cote INIST : 9560, 35400005177648.0040