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

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.

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.

Study Overview

• Status: Completed
• Conditions: Non-malignant Pain; Malignant Pain
• Intervention / Treatment: Drug: Oxycodone; Drug: Naloxone

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 Type: Interventional
• Enrollment (Actual): 155
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Germany
  • Mainz, Germany

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OXN PR HST; Prolonged release oxycodone/naloxone higher strength tablets	Drug: Oxycodone
Active Comparator: OXN PR LST; Prolonged release oxycodone/naloxone lower strength tablets	Drug: Naloxone; Prolonged Release Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
(mean of subjects average pain over the last 24 hours as assessed by the pain intensity scale.)	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	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).		Week 2, 3 5 and 6 from date of randomisation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 bowel function (assess BFI and laxative use)	To assess BFI and laxative use	Week 1,2,3,4,5 and 6 from date of randomisation
To assess quality of life based on the EuroQol EQ-5D.	EuroQol EQ-5D is a standardized instrument for use as a measure of health outcome.	Visit 3 and visit 6 from date of randomisation
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

Collaborators and Investigators

• Sponsor: Mundipharma Research GmbH & Co KG

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: October 13, 2014
• First Submitted That Met QC Criteria: December 19, 2014
• First Posted (Estimate): December 22, 2014

Study Record Updates

• Last Update Posted (Estimate): November 4, 2016
• Last Update Submitted That Met QC Criteria: November 3, 2016
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: oxycodone naloxone combination; severe chronic and non-malignant pain; Malignant and non-malignant pain that requires around-the clock opioid therapy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Narcotic Antagonists; Naloxone; Oxycodone
• Other Study ID Numbers: OXN3508; 2013-004888-31 (EudraCT Number)