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

Primary Purpose

Chronic Pain

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Oxycodone/naloxone
Sponsored by
Mundipharma Korea Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Pain focused on measuring moderate to severe non-malignant chronic pain

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • AMC

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Group A

Group B

Arm Description

Start oxycodone/naloxone 10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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).
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.
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.
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).

Full Information

First Posted
March 12, 2013
Last Updated
January 19, 2017
Sponsor
Mundipharma Korea Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT01811186
Brief Title
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

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mundipharma Korea Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Objectives: Objective of main interest - To assess the drop-out rate caused by adverse event* after 6 weeks treatment 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
moderate to severe non-malignant chronic pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
261 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Other
Arm Description
Start oxycodone/naloxone 10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.
Arm Title
Group B
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Oxycodone/naloxone
Other Intervention Name(s)
Targin
Intervention Description
Oxycodone/naloxone titration
Primary Outcome Measure Information:
Title
Drop-out Rate Caused by Adverse Event After 6 Weeks Treatment
Description
To assess the drop-out rate caused by adverse event* after 6 weeks treatment
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
The Drop-out Rate Due to an Adverse Event After 1 Week Treatment With the Study Drug.
Description
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.
Time Frame
1 week
Title
The Change of Pain Intensity Scores(NRS) From Baseline After 6 Weeks Treatment With the Study.
Description
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).
Time Frame
6 weeks
Title
Change of Quality of Life (EQ-5D) Score After 6 Weeks Treatment With the Study Drug
Description
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.
Time Frame
6 weeks
Title
Assessment of Investigator's Overall Satisfaction After 6 Weeks Treatment With the Study Drug
Description
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.
Time Frame
6 weeks
Title
Assessment of Subject's Overall Satisfaction After 6 Weeks Treatment With the Study Drug
Description
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).
Time Frame
6weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hoseong Lee, Dr.
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
AMC
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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

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