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.

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02321397

Enrollment

155

Registered

2014-12-22

Start date

2014-11-30

Completion date

2016-09-30

Last updated

2016-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Pain, Non-malignant Pain

Keywords

oxycodone naloxone combination, severe chronic and non-malignant pain, Malignant and non-malignant pain that requires around-the clock opioid therapy

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).

Interventions

DRUGOxycodone

DRUGNaloxone

Prolonged Release Tablets

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
(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
Equivalent bowel function as assessed by the Bowel Function Index (BFI).	Week 2, 3 5 and 6 from date of randomisation.	—

Secondary

Measure	Time frame	Description
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.
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	—
Pain right now scores at intake of oxycodone/naloxone tablets.	Week 2,3,5 and 6 from date of randomisation	—
Number of participants with adverse events, high/low laboratory values and clinically significant ECG findings.	Up to 35 weeks	—
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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026