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

Status and phase

Completed

Phase 3

Phase 2

Conditions

Malignant Pain

Non-malignant Pain

Treatments

Drug: Oxycodone

Drug: Naloxone

Study type

Interventional

Funder types

Industry

Identifiers

NCT02321397

OXN3508

2013-004888-31 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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).

Enrollment

155 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.