An Interventional Study to Compare the Efficacy and Tolerability With Targin® in Non-malignant Chronic Pain (GLORY)

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Objectives:

1. Objective of main interest

• To assess the drop-out rate caused by adverse event* after 6 weeks treatment

2. Further objectives

• To assess the drop-out rate caused by adverse event* after 1 week treatment

• To assess the pain reduction rate after 6 weeks treatment from baseline

• To assess the Euroquol (EQ-5D) quality of life

• To assess physician's overall satisfaction

• To assess subject's overall satisfaction

• To assess safety

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mundipharma Korea Ltd
• Treatments: Naloxone; Oxycodone

Criteria

Inclusion Criteria:

• Male or female ≥ 20 and <80 years of age

• Patients who have non-malignant chronic pain(≥90 days)

• Patients who have moderate to severe pain intensity which is not controlled with non-strong opioid

• Naïve patients for Oxycodone/Naloxone (Naïve patient defined as who did not treated for 90 days)

• Naïve patients for strong opioid (Naïve patient defined as who did not treated for 90 days)

• Patients who signed a written informed consent form

Exclusion Criteria:

• Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant.

• Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive urine pregnancy test

• Patients with known hypersensitivity to Oxycodone/Naloxone or to any of the excipients

• Patient who needs acute dose titration or whose pain intensity fluctuate significantly in a short period according to investigator's judgment

• Having used other investigational drugs at the time of enrollment, or within 30 days of enrollment