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)

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

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Drug: Oxycodone/naloxone

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.

• Study Type: Interventional
• Enrollment (Actual): 261
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • AMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group A; Start oxycodone/naloxone 10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.	Drug: Oxycodone/naloxone; Oxycodone/naloxone titration; Other Names: Targin
Other: Group B; Start oxycodone/naloxone 5/2.5mg b.i.d titration-> 10/5mg b.i.d.->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.	Drug: Oxycodone/naloxone; Oxycodone/naloxone titration; Other Names: Targin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drop-out Rate Caused by Adverse Event After 6 Weeks Treatment	To assess the drop-out rate caused by adverse event* after 6 weeks treatment	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Drop-out Rate Due to an Adverse Event After 1 Week Treatment With the Study Drug.	The drop-out rate due to an adverse event after treatment (1 week) by treatment arm were summarized and presented as frequency and percentage, and the inter-group difference were compared by using a Chi-square test or Fisher's exact test.	1 week
The Change of Pain Intensity Scores(NRS) From Baseline After 6 Weeks Treatment With the Study.	Change in numeric rating scales (NRS) such as score for average pain levels over the previous 24 hours, from baseline to 6weeks. NRS score was measured from 0 (No pain) to 10(worst pain imaginable).	6 weeks
Change of Quality of Life (EQ-5D) Score After 6 Weeks Treatment With the Study Drug	EQ-5D to measure of health related quality of life should be answered as one of 3 levels about current condition for 5 dimensions and was calculated total average by giving a weighting on 3 level of answers (EQ-5D levels into 'no problems' (level 1) and 'problems' (level 2 and 3)). Table of scores by each level for EQ-5D items: mobility(level 1=0, level2=0.069,level 3=0.314), self care(level 1=0, level2=0.104,level 3=0.214), usual activities(level 1=0, level2=0.036,level 3=0.094), pain/discomfort (level 1=0, level2=0.,level 3=0.386) and anxiety/depression(level 1=0, level2=0.071,level 3=0.2) *EQ-5D Total = 1 - 0.081 - (the score of the each level) - 0.269 (if at least one of level 3 presents) EQ-5D total score could be 0.919 in maximum and -0.594 in minimum if case all index indicates the level 3. So, if EQ-5D total score closed by "1" means that the healthy condition and high quality of life.	6 weeks
Assessment of Investigator's Overall Satisfaction After 6 Weeks Treatment With the Study Drug	Investigator's overall satisfaction after treatment (6 weeks) (Clinical Global Impression of Change Scale(CGIC) 7 point scale) by treatment arm were summarized and presented as frequency and proportion, and the inter-group difference were compared by using a Chi-square test or Fisher's exact test.	6 weeks
Assessment of Subject's Overall Satisfaction After 6 Weeks Treatment With the Study Drug	At each visit, the subject assessed the overall satisfaction for efficacy by using the 7 point scale of Patient Global Impression of Change Scale(PGIC).	6weeks

Collaborators and Investigators

• Sponsor: Mundipharma Korea Ltd
• Investigators: Principal Investigator: Hoseong Lee, Dr., Asan Medical Center

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: March 12, 2013
• First Submitted That Met QC Criteria: March 12, 2013
• First Posted (Estimate): March 14, 2013

Study Record Updates

• Last Update Posted (Actual): March 10, 2017
• Last Update Submitted That Met QC Criteria: January 19, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: moderate to severe non-malignant chronic pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Narcotic Antagonists; Naloxone; Oxycodone
• Other Study ID Numbers: OXN12-KR-403

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO