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A randomised, double-blind, parallel group multicenter study to demonstrate non-inferiority of the analgesic efficacy of oxycodone/naloxone 10/5 or 20/10 mg prolonged release tablets (OXN PR) BID comp...

Mise à jour : Il y a 4 ans
Référence : EUCTR2009-016957-17

A randomised, double-blind, parallel group multicenter study to demonstrate non-inferiority of the analgesic efficacy of oxycodone/naloxone 10/5 or 20/10 mg prolonged release tablets (OXN PR) BID compared to oxycodone 10 or 20 mg prolonged release tablets (OXY PR) BID in subjects with postoperative pain after knee arthroplasty

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Extrait

• To demonstrate that treatment with OXN PR tablets is non-inferior to treatment with OXY PR tablets in terms of analgesic efficacy in patients with postoperative pain after knee arthroplasty based on average pain intensity scores at rest. Dosing will commence after the end of postoperative epidural analgesia. Subjects will rate their pain intensity on an 11-point numerical rating scale (NRS) of 0-10, twice a day, 1 hour after each dose of study medication for 5 doses (2.5 days).

Critère d'inclusion

  • postoperative pain after knee arthroplasty

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