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

Phase 2

Completed

• Conditions: Malignant Pain; Non-malignant Pain
• Interventions: Drug: Oxycodone; Drug: Naloxone

• Registration Number: NCT02321397
• Lead Sponsor: Mundipharma Research GmbH & Co KG

Brief 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.

Detailed 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).

Study Timeline

• Study First Submitted: 2014-10-13
• Study Start: 2014-11
• Study First Submitted QC: 2014-12-19
• Study First Posted: 2014-12-22
• Status Verified: 2015-12
• Primary Completion: 2016-03
• Study Completion: 2016-09
• Last Update Submitted: 2016-11-03
• Last Update Posted: 2016-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 155

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
OXN PR HST	Oxycodone	Prolonged release oxycodone/naloxone higher strength tablets
OXN PR LST	Naloxone	Prolonged release oxycodone/naloxone lower strength tablets

Primary Outcome Measures

Name	Time	Method
Equivalent bowel function as assessed by the Bowel Function Index (BFI).	Week 2, 3 5 and 6 from date of randomisation.
(mean of subjects average pain over the last 24 hours as assessed by the pain intensity scale.)	24 hours at one day in week 2, 3 5 and 6 from date of randomisation.	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

Secondary Outcome Measures

Name	Time	Method
Number of participants with adverse events, high/low laboratory values and clinically significant ECG findings.	Up to 35 weeks
Pain right now scores at intake of oxycodone/naloxone tablets.	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.	Week 1,2,3,4,5 and 6 from date of randomisation
To assess quality of life based on the EuroQol EQ-5D.	Visit 3 and visit 6 from date of randomisation	EuroQol EQ-5D is a standardized instrument for use as a measure of health outcome.
To assess bowel function (assess BFI and laxative use)	Week 1,2,3,4,5 and 6 from date of randomisation	To assess BFI and laxative use