Titre du document / Document title

Treatment of acute musculoskeletal disorders with piroxicam fast-dissolving dosage form tablets versus naproxen film-coated tablets : A pilot study

Auteur(s) / Author(s)

CRIELAARD J.-M. ⁽¹⁾ ; CHAPELLE C. H. ⁽²⁾ ; JOOS E. ⁽²⁾ ; SPANS E. ⁽²⁾ ; LYSENS R. ⁽²⁾ ;

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

⁽¹⁾ Musculoskeletal Medicine-Physical Medicine-Electromyography, University of Liège, Liège, BELGIQUE
⁽²⁾ Department of Physical Medicine and Rehabilitation, University Hospital Gasthuisberg, Herestraat, Leuven, BELGIQUE

Résumé / Abstract

This open-label, active-controlled, unmasked, parallel group, randomized study compared the efficacy and tolerability of piroxicam fast-dissolving dosage form (FDDF) tablets (20-mg twice daily on the first 2 days and 20 mg/d thereafter) with those of naproxen sodium film-coated (FC) tablets (550 to 1100 mg on the first day and 275 mg 3 times daily thereafter). Treatment lasted 9 to 10 days with no dosage adjustments. One hundred twenty-nine patients from 12 centers were included in the study. Efficacy in acute musculoskeletal disorders was assessed by means of a 10-cm visual analog scale; onset of action was also recorded. Patients' and investigators' assessments of symptoms were done at 4 visits: days 0, 4, 8, and 15. The safety profile was assessed by recording all adverse events. Patients and investigators also provided overall tolerability assessments. No significant between-group differences in terms of pain relief or onset of action were found. Pain relief started 30 minutes after the first intake of medication and became significant after 3 hours in both groups. Assessments of change in symptoms at day 4 (P = 0.002), day 8 (P = 0.001), and day 15 (P = 0.001) showed significantly better scores with piroxicam than with naproxen. Pain on movement and tenderness on palpation were comparable in both groups. Active motion at the affected site improved significantly between baseline and the last visit in the piroxicam group only (P = 0.019). Resumption of a specific activity and overall assessment of efficacy were significantly better in the piroxicam group than in the naproxen group (P = 0.006 and P < 0.001, respectively). No serious adverse events were reported in either group, and no between-group differences in tolerability were observed. Results of this pilot study suggest that piroxicam FDDF tablets and naproxen FC tablets have an equally rapid onset of action and are equally well tolerated. Although larger, masked, randomized, placebo-controlled clinical trials should be performed, the overall efficacy of piroxicam in the treatment of acute musculoskeletal injuries was better than that of naproxen.

Revue / Journal Title

Current therapeutic research   ISSN 0011-393X   CODEN CTCEA9 

Source / Source

1999, vol. 60, n^o12, pp. 661-671 (17 ref.)

Langue / Language

Anglais

Editeur / Publisher

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

Mots-clés anglais / English Keywords

Tendinitis ; Sprain ; Piroxicam ; Naproxen ; Non steroidal antiinflammatory agent ; Comparative study ; Chemotherapy ; Treatment ; Human ; Dosage form ; Tablet ; Coated tablet ; Analgesic ; Immediate release form ; Treatment efficiency ; Toxicity ; Oxicam derivatives ; Arylpropionic acid derivatives ; Analgesia ; Diseases of the osteoarticular system ; Juxtaarticular disease ; Trauma ;

Mots-clés français / French Keywords

Tendinite ; Entorse ; Piroxicam ; Naproxène ; Antiinflammatoire non stéroïde ; Etude comparative ; Chimiothérapie ; Traitement ; Homme ; Forme pharmaceutique ; Comprimé ; Comprimé enrobé ; Analgésique ; Forme libération immédiate ; Efficacité traitement ; Toxicité ; Oxicam dérivé ; Arylpropionique acide dérivé ; Analgésie ; Système ostéoarticulaire pathologie ; Juxtaarticulaire pathologie ; Traumatisme ;

Mots-clés espagnols / Spanish Keywords

Tendinitis ; Esguince ; Piroxicam ; Naproxeno ; Antiinflamatorio no esteroide ; Estudio comparativo ; Quimioterapia ; Tratamiento ; Hombre ; Forma farmacéutica ; Tableta ; Tableta cubierta ; Analgésico ; Forma liberación inmediata ; Eficacia tratamiento ; Toxicidad ; Oxicam derivado ; Arilpropionico ácido derivado ; Analgesia ; Sistema osteoarticular patología ; Yuxtaarticular patología ; Traumatismo ;

Localisation / Location

INIST-CNRS, Cote INIST : 9560, 35400008130420.0040