Overview

This trial has been completed.

Conditions malignant pain, non-malignant pain
Treatments oxycodone, naloxone
Phase phase 2/phase 3
Sponsor Mundipharma Research GmbH & Co KG
Start date November 2014
End date March 2016
Trial size 155 participants
Trial identifier NCT02321397, 2013-004888-31, OXN3508

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
Prolonged release oxycodone/naloxone higher strength tablets
oxycodone
(Active Comparator)
Prolonged release oxycodone/naloxone lower strength tablets
naloxone
Prolonged Release Tablets

Primary Outcomes

Measure
(mean of subjects average pain over the last 24 hours as assessed by the pain intensity scale.)
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.

Secondary Outcomes

Measure
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)
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.
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

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria - Subjects who are receiving WHO step III opioid analgesic medication for the treatment of non-malignant or malignant pain. - Documented history of non-malignant or malignant pain that requires around-the-clock opioid therapy Exclusion Criteria - Females who are pregnant or lactating. - Subjects with evidence or significant structural abnormalities of the gastrointestinal tract. - Subjects with evidence of impaired liver/kidney function upon entry into the study.

Additional Information

Official title Randomised, Double-blind, Double-dummy, Cross-over Multicenter Study to Demonstrate Equivalence in Analgesic Efficacy & Bowel Function Taking Oxycodone Equivalents of 120 & 160 mg Per Day as Achieved With the Higher OXN PR Tablet Strengths (OXN60/30 mg PR, OXN80/40 mg PR) BID Compared to the Identical Daily Dose Taken as a Combination of Lower Tablet Strengths in Subjects With Non-malignant or Malignant Pain That Requires Around-the-clock Opioid Therapy.
Description 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).
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Mundipharma Research GmbH & Co KG.