Clinical trial NCT01811186: An Interventional Study to Compare the Efficacy and Tolerability With Targin® in Non-malignant Chronic Pain (GLORY)
Official 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Pain
Keywords: moderate to severe non-malignant chronic pain
Lead sponsor: Mundipharma Korea Ltd
Sponsor class: INDUSTRY
First posted: 2013-03-14
Enrollment: 261
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility 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

Primary outcomes:
measure: Drop-out Rate Caused by Adverse Event After 6 Weeks Treatment
timeFrame: 6 weeks
Secondary outcomes:
measure: The Drop-out Rate Due to an Adverse Event After 1 Week Treatment With the Study Drug.
timeFrame: 1 week
measure: The Change of Pain Intensity Scores(NRS) From Baseline After 6 Weeks Treatment With the Study.
timeFrame: 6 weeks
measure: Change of Quality of Life (EQ-5D) Score After 6 Weeks Treatment With the Study Drug
timeFrame: 6 weeks
measure: Assessment of Investigator's Overall Satisfaction After 6 Weeks Treatment With the Study Drug
timeFrame: 6 weeks
measure: Assessment of Subject's Overall Satisfaction After 6 Weeks Treatment With the Study Drug
timeFrame: 6weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: AMC
Study officials:
affiliation: Asan Medical Center
name: Hoseong Lee, Dr.
role: PRINCIPAL_INVESTIGATOR
References: