A Phase 2/3 interventional study of Oxycodone and Naloxone in Malignant Pain and Non-malignant Pain, sponsored by Mundipharma Research GmbH & Co KG. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-04.
Sponsored by Mundipharma Research GmbH & Co KG · Phase 2/3, Interventional, and Treatment
This study is aimed to demonstrate equivalence between combinations of lower strength OXN PR tablets (OXN PR LST) and single higher strength OXN PR tablets (OXN PR HST) taken at the same overall daily dose.
Study OXN3508 is a multicenter double-blind, double-dummy, randomised, cross-over, 2-period, phase III study in male and female subjects with severe non-malignant or malignant pain that requires around-the-clock opioid therapy at a daily dose of 120/60 mg or 160/80 mg oxycodone/naloxone prolonged release (OXN PR).
Mundipharma Research GmbH & Co KG is the lead sponsor of 16 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria
Prolonged release oxycodone/naloxone higher strength tablets
Drug: Oxycodone
Prolonged release oxycodone/naloxone lower strength tablets
Drug: Naloxone
Prolonged Release Tablets
(mean of subjects average pain over the last 24 hours as assessed by the pain intensity scale.)
Pain scores based on the mean of subjects average pain over the last 24 hours as assessed by the pain intensity scale. 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
Time frame: 24 hours at one day in week 2, 3 5 and 6 from date of randomisation.
Equivalent bowel function as assessed by the Bowel Function Index (BFI).
Time frame: Week 2, 3 5 and 6 from date of randomisation.
Pain scores of subjects average pain over the last 24 hours and rescue medication use.
Time frame: Week 1,2,3,4,5 and 6 from date of randomisation
To assess bowel function (assess BFI and laxative use)
To assess BFI and laxative use
Time frame: Week 1,2,3,4,5 and 6 from date of randomisation
To assess quality of life based on the EuroQol EQ-5D.
EuroQol EQ-5D is a standardized instrument for use as a measure of health outcome.
Time frame: Visit 3 and visit 6 from date of randomisation
Number of participants with adverse events, high/low laboratory values and clinically significant ECG findings.
Time frame: Up to 35 weeks
Pain right now scores at intake of oxycodone/naloxone tablets.
Time frame: Week 2,3,5 and 6 from date of randomisation
This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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Mundipharma Research GmbH & Co KG