An exploratory, randomised, double-blind, single-dummy, placebo controlled, parallel group study to demonstrate the analgesic efficacy of oxycodone/naloxone prolonged release tablets (OXN PR) in addit...

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Reference: EUCTR2008-005815-17

An exploratory, randomised, double-blind, single-dummy, placebo controlled, parallel group study to demonstrate the analgesic efficacy of oxycodone/naloxone prolonged release tablets (OXN PR) in addition to pregabalin compared to pregabalin alone in opioid-naïve subjects treated with pregabalin suffering from severe pain due to diabetic polyneuropathy

Woman and Man

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Extract

To show superior analgesic efficacy of OXN PR in addition to a patient’s current dose of pregabalin compared to pregabalin alone based on the “Short-Form McGill Pain Questionnaire” assessed at each visit. (Melzack, 1987).


Inclusion criteria

  • Severe pain due to diabetic polyneuropathy