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A randomised, double-blind, double-dummy, parallel-group multicentre study to demonstrate non-inferiority in pain and locomotor function and improvement in symptoms of constipation in subjects with mo...

Mise à jour : Il y a 4 ans
Référence : EUCTR2008-002670-36

A randomised, double-blind, double-dummy, parallel-group multicentre study to demonstrate non-inferiority in pain and locomotor function and improvement in symptoms of constipation in subjects with moderate to severe pain due to osteoarthritis (OA) of the knee and/or hip taking oxycodone equivalent of 20 - 80 mg/day as oxycodone/naloxone prolonged release (OXN PR) compared to subjects taking oxycodone prolonged release tablets (OxyPR) alone

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Extrait

• To demonstrate that the treatment with OXN PR tablets is non-inferior to the treatment with OxyPR with regards to analgesic efficacy and locomotor function as assessed by the Western Ontario and McMaster Universities Osteoarthritis Composite Index (WOMAC VA3.1, visual analogue scale) in subjects with moderate to severe OA pain. • To demonstrate that subjects with moderate to severe OA pain taking oxycodone/naloxone prolonged release tablets have improvement in symptoms of constipation as measured by the bowel function index (BFI) compared to subjects taking oxycodone prolonged release tablets alone.

Critère d'inclusion

  • Pain, locomotor function and improvement in constipation in osteoarthritis patients taking opioids

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