A study which will show the equivalence in analgesic efficacy and bowel function taking oxycodone equivalents of 120 and 160 mg per day as achieved with the higher OXN PR tablet strengths (OXN60/30 mg PR, OXN80/40 mg PR) twice daily compared to the identical daily dose taken as a combination of lower tablet strengths in subjects with non-cancer or cancer pain that requires around-the-clock opioid therapy Primary objective: To demonstrate equivalence between multiple lower strength OXN PR tablets and a single higher strength OXN PR tablet taken at the same overall total daily dose as shown by: • Anal...

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not applicable The aim of this study is to investigate the efficacy and safety of OXN PR in the treatment of BPS and to further support the evidence for the use of opioids in this indication. The main objective is ...

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A Randomized, Double-blind, Placebo- and Active-controlled, Double-dummy, Parallel Group Study to Determine the Safety and Efficacy of Oxycodone/Naloxone Prolonged-release Tablets in Subjects with Moderate to Severe, Chronic Nonmalignant Pain To demonstrate the superiority of OXN over placebo on the time from the initial dose of study medication to multiple (ie, recurring) pain events (inadequate analgesia) during the Double-blind Phase.

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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 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 vi...

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Efficacy and Safety in a randomised acute pain study of MR308. Eficacia y Seguridad de MR308 en un estudio aleatorizado de dolor agudo To demonstrate the efficacy of MR308 doses in the Treatment of acute moderate to severe pain. Efficacy will be assessed by showing superiority of MR308 doses over Placebo and non-inferiority compared ...

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A study to demonstrate the improvement in symptoms of constipation in subjects with cancer on non-cancer related pain requiring round the clock opioid therapy 1. To demonstrate that subjects taking OXN PR have improvement in symptoms of constipation as measured by the Bowel Function Index (BFI) compared to subjects taking OxyPR. 2. To demonstrate non-infer...

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A randomised, double-blind, active-controlled, double-dummy, parallel group study to determine the safety and efficacy of oxycodone / naloxone prolonged release tablets in subjects with moderate to severe, chronic cancer pain To determine the improvement in symptoms of constipation in subjects receiving treatment with oxycodone/naloxone prolonged release tablets (OXN) compared to subjects receiving oxycodone prolonged rele...

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Efficacy and Safety in a randomised acute pain study of MR308 To demonstrate the efficacy of MR308 doses in the Treatment of acute moderate to severe pain. Efficacy will be assessed by showing superiority of MR308 doses over Placebo and non-inferiority compared ...

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A study to evaluate the effect and tolerability of laxatives (medicines against constipation) for the reversal of constipation caused by opioids (medicines against pain) Primary Objective •To assess the effect of SLT on the frequency of soft (stool of type 3, 4 or 5 on the Bristol Stool Form Scale (BSFS)) complete bowel movements (SCBMs) per week in subjects taking W...

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A study which assesses the effects of two pain medications: oxycodone/naloxone prolonged-release tablets (OXN PR) and oxycodone prolonged-release tablets (OxyPR) on the gastrointestinal system of subjects suffering from non-cancer pain • Quantitative analysis of intestinal microbiota as determined in stool samples of subjects treated with OXN PR compared to those treated with OxyPR. • To assess orocaecal transit time on the basis o...

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