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Completed

NCT Number: NCT01811186

An Interventional Study to Compare the Efficacy and Tolerability With Targin® in 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

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

AMC

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxycodone/Naloxone

Drug

Oxycodone/naloxone titration

Other names: Targin

Primary outcomes

  1. Drop-out Rate Caused by Adverse Event After 6 Weeks Treatment

    Time frame: 6 weeks

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

Secondary outcomes

  1. The Drop-out Rate Due to an Adverse Event After 1 Week Treatment With the Study Drug.

    Time frame: 1 week

    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.

  2. The Change of Pain Intensity Scores(NRS) From Baseline After 6 Weeks Treatment With the Study.

    Time frame: 6 weeks

    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).

  3. Change of Quality of Life (EQ-5D) Score After 6 Weeks Treatment With the Study Drug

    Time frame: 6 weeks

    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.

  4. Assessment of Investigator's Overall Satisfaction After 6 Weeks Treatment With the Study Drug

    Time frame: 6 weeks

    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.

  5. Assessment of Subject's Overall Satisfaction After 6 Weeks Treatment With the Study Drug

    Time frame: 6weeks

    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).

Sponsors and collaborators

Lead sponsor

Mundipharma Korea Ltd

Industry

Registry information

Official study title

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)

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Mar 14, 2013
Registry last updated
Mar 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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