NCT01811186

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

An Interventional Study to Compare the Efficacy and Tolerability of Current and Slow Titration With Targin® in the Treatment of Moderate to Severe Non-malignant Chronic Pain (GLORY)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 261 (actual)
• Sponsor: Mundipharma Korea Ltd · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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

Detailed description

Study Design (Methodology): This will be a single center, open-label, randomised, phase IV, exploratory interventional study to compare the efficacy and tolerability of current titration patterns and slow titration pattern with Targin® (Oxycodone/Naloxone) in the treatment of moderate to severe non-malignant chronic pain patients who are dissatisfied with their current analgesic medication World Health Organisation (WHO) step II analgesics). Upon providing written informed consent, subject will be screened in the study and assessment will be performed at that time such as safety laboratory assessments, physical examination, vital sign, medical history taking, 24 hours pain intensity score. If the patient is eligible in inclusion/exclusion criteria at the time of visit 1, the patient will be randomized in a 1:1 ratio to allocate in Group A or Group B. Re-screening, study drug dose interruption is not allowed.

Conditions

• Chronic Pain

Interventions

Type	Name	Description
DRUG	Oxycodone/naloxone	Oxycodone/naloxone titration

Timeline

• Start date: 2012-12-01
• Primary completion: 2014-01-01
• Completion: 2014-06-01
• First posted: 2013-03-14
• Last updated: 2017-03-10
• Results posted: 2017-03-10

Locations

1 site across 1 country: South Korea