An exploratory, randomised, active-controlled, double-blind, double-dummy, parallel group pilot study to determine the ability of oxycodone/naloxone prolonged release tablets (OXN) to reduce the number of subjects developing symptoms of opioid induced constipation compared to morphine prolonged release tablets (MOR PR) in opioid naïve, non-constipated subjects with non malignant pain that require opioid treatment.

Registry ID
EUCTR2007-005922-62
Source registry
EUCTR
Status
Completed
Phase
PHASE2
Sponsor
Mundipharma Research GmbH & Co. KG
Start date
2008-02-14
Completion date
2008-12-26
Last update
2026-08-16

Conditions

Summary

To demonstrate that in a group of opioid naïve non-constipated subjects with non malignant pain treatment with OXN tablets leads to a higher responder rate compared to MOR PR. A responder is defined as a subject who meets the following criteria: A subject, whose bowel function improved, did not change or did not have an unacceptable worsening compared to pre randomisation (subjective evaluation). Subjective evaluation: To what extent did your bowel function (e.g. frequency of defecation, stool consistency, ease of defecation, painful defecation) change during the treatment with study medication: Bowel function is substantially improved; Bowel function is slightly improved; Bowel function is unchanged; Bowel function is slightly impaired, but still acceptable; Bowel function is substantially impaired, no longer acceptable A subject who does not discontinue from the study due to an AE of constipation during the first 14 +/- 2 days of the double-blind phase.

Locations

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