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

Mundipharma Research GmbH & Co KG155 enrolled

Overview

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 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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

155

Conditions

Malignant Pain Non-malignant Pain

Interventions

OxycodoneDRUG

NaloxoneDRUG

Prolonged Release Tablets

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Unnamed facility

Mainz, Germany

Outcomes

Primary Outcomes

(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

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

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)

To 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.

EuroQol EQ-5D is a standardized instrument for use as a measure of health outcome.

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

Data from ClinicalTrials.gov

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