Oxycodone-naloxone Prolonged Release Tablets in Relieving Opioid-related Constipation

Phase 3 Completed Mundipharma Research GmbH & Co KG

RandomizedParallel-groupDouble-blindTreatment

Summary

The primary objective is to demonstrate that patients taking oxycodone/naloxone prolonged release tablets have improvement in symptoms of constipation compared to subjects taking oxycodone prolonged release tablets alone.

Timeline

Start: 2006-04
Primary completion: 2008-07
Completion: 2008-09

Outcome

Met primary endpoint

paper No statistically significant differences in analgesic efficacy were observed for the two treatments (p = 0.3197; non-inferiority p < 0.0001; 95% CI -0.07, 0.23) PMID 20920236 ↗

Publications

Lowenstein O, Leyendecker P, Lux EA, Blagden M, Simpson KH, Hopp M, Bosse B, Reimer K. Efficacy and safety of combined prolonged-release oxycodone and naloxone in the management of moderate/severe chronic non-malignant pain: results of a prospectively designed pooled analysis of two randomised, double-blind clinical trials. BMC Clin Pharmacol. 2010 Sep 29;10:12. doi: 10.1186/1472-6904-10-12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Naloxone	Small molecule	—	—
Subject	Oxycodone	Other / unclassified	—	—

Indications

No indication recorded.