drugset / Trial / NCT02321397

To Demonstrate Equivalence in Analgesic Efficacy & Bowel Function Between OXN PR Higher Dose & Lower Dose Tablet Strengths in Subjects With Non-cancer or Cancer Pain

NCT02321397

Phase 2/3 Completed 155 enrolled Mundipharma Research GmbH & Co KG
RandomizedCrossoverDouble-blindTreatment

Summary

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.

Timeline

Start
2014-11
Primary completion
2016-03
Completion
2016-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Naloxone Small molecule 60 mg
Comparator Naloxone Small molecule 80 mg
Subject Oxycodone Other / unclassified 120 mg
Subject Oxycodone Other / unclassified 160 mg

Indications

No indication recorded.