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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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ClinicalTrials.gov Identifier: NCT01811186
Recruitment Status : Completed
First Posted : March 14, 2013
Results First Posted : March 10, 2017
Last Update Posted : March 10, 2017
Sponsor:
Information provided by (Responsible Party):
Mundipharma Korea Ltd

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition Chronic Pain
Intervention Drug: Oxycodone/naloxone
Enrollment 261
Recruitment Details Safety set: 261 patients were enrolled. ITT set was 258, 3 patients of the 261 patients deviated from inclusion/exclusion criteria.
Pre-assignment Details  
Arm/Group Title Start Oxycodone/Naloxone 10/5mg b.i.d. Start Oxycodone/Naloxone 5/2.5mg b.i.d
Hide Arm/Group 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->10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.
Period Title: Overall Study
Started 132 126
Completed 61 64
Not Completed 71 62
Reason Not Completed
Adverse Event             54             38
Protocol Violation             5             6
Withdrawal by Subject             5             10
Lack of Efficacy             3             6
Lost to Follow-up             4             2
Arm/Group Title Start Oxycodone/Naloxone 10/5mg b.i.d Start Oxycodone/Naloxone 5/2.5mg b.i.d Total
Hide Arm/Group 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. Total of all reporting groups
Overall Number of Baseline Participants 132 126 258
Hide Baseline Analysis Population Description
Safety set: 261 ITT set: 258(3 patients were deviated inclusion/exclusion criteria among 261)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 132 participants 126 participants 258 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
77
  58.3%
64
  50.8%
141
  54.7%
>=65 years
55
  41.7%
62
  49.2%
117
  45.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 132 participants 126 participants 258 participants
60.63  (9.69) 61.15  (11.94) 60.88  (10.83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 132 participants 126 participants 258 participants
Female
81
  61.4%
84
  66.7%
165
  64.0%
Male
51
  38.6%
42
  33.3%
93
  36.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 132 participants 126 participants 258 participants
132 126 258
1.Primary Outcome
Title Drop-out Rate Caused by Adverse Event After 6 Weeks Treatment
Hide Description To assess the drop-out rate caused by adverse event* after 6 weeks treatment
Time Frame 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat analysis set: 258 patients (Last Observation Carried Forward)
Arm/Group Title Start Oxycodone/Naloxone 10/5mg b.i.d. Start Oxycodone/Naloxone 5/2.5mg b.i.d.
Hide Arm/Group 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->10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.
Overall Number of Participants Analyzed 132 126
Measure Type: Number
Unit of Measure: percentage of participants
40.91 30.16
2.Secondary Outcome
Title The Drop-out Rate Due to an Adverse Event After 1 Week Treatment With the Study Drug.
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat analysis set: 258(Last observation Carried Forward)
Arm/Group Title Start Oxycodone/Naloxone 10/5mg b.i.d. Start Oxycodone/Naloxone 5/2.5mg b.i.d.
Hide Arm/Group 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->10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.
Overall Number of Participants Analyzed 132 126
Measure Type: Number
Unit of Measure: percentage of participants
28.79 19.84
3.Secondary Outcome
Title The Change of Pain Intensity Scores(NRS) From Baseline After 6 Weeks Treatment With the Study.
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set: 258
Arm/Group Title Start Oxycodone/Naloxone 10/5mg b.i.d. Start Oxycodone/Naloxone 5/2.5mg b.i.d.
Hide Arm/Group 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->10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.
Overall Number of Participants Analyzed 132 126
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.62  (1.90) -1.48  (1.82)
4.Secondary Outcome
Title Change of Quality of Life (EQ-5D) Score After 6 Weeks Treatment With the Study Drug
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set.
Arm/Group Title Start Oxycodone/Naloxone 10/5mg b.i.d. Start Oxycodone/Naloxone 5/2.5mg b.i.d.
Hide Arm/Group 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->10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.
Overall Number of Participants Analyzed 61 64
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.14  (0.26) 0.07  (0.22)
5.Secondary Outcome
Title Assessment of Investigator’s Overall Satisfaction After 6 Weeks Treatment With the Study Drug
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set: 171. Last visit(Visit 5) data was handled as LOCF. However, Missing Number as visit 3 for assessment of Investigator’s overall satisfaction after 6 weeks treatment with the study drug was Group A = 50, Group B=37.
Arm/Group Title Start Oxycodone/Naloxone 10/5mg b.i.d Start Oxycodone/Naloxone 5/2.5mg b.i.d
Hide Arm/Group 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->10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.
Overall Number of Participants Analyzed 82 89
Measure Type: Number
Unit of Measure: participants
Very much improved 2 2
Much improved 27 30
Minimally improved 48 43
No change 5 14
Minimally worse 0 0
Much worse 0 0
very much worse 0 0
6.Secondary Outcome
Title Assessment of Subject’s Overall Satisfaction After 6 Weeks Treatment With the Study Drug
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set: 171. Last visit(Visit 5) data was handled as LOCF. However, Missing Number as visit 3 for assessment of Investigator’s overall satisfaction after 6 weeks treatment with the study drug was Group A = 50, Group B=37.
Arm/Group Title Start Oxycodone/Naloxone 10/5mg b.i.d. Start Oxycodone/Naloxone 5/2.5mg b.i.d.
Hide Arm/Group 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.
Overall Number of Participants Analyzed 82 89
Measure Type: Number
Unit of Measure: participants
Very much improved 2 2
Much improved 24 28
Minimally improved 44 42
No change 11 16
Minimally worse 0 1
Much worse 1 0
Very much worse 0 0
Time Frame Safety set: Safety set included data obtained from all subjects who administered at least one dose of the study drug. Patients were followed by 6 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Start Oxycodone/Naloxone 10/5mg b.i.d Start Oxycodone/Naloxone 5/2.5mg b.i.d
Hide Arm/Group 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.
All-Cause Mortality
Start Oxycodone/Naloxone 10/5mg b.i.d Start Oxycodone/Naloxone 5/2.5mg b.i.d
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Start Oxycodone/Naloxone 10/5mg b.i.d Start Oxycodone/Naloxone 5/2.5mg b.i.d
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/133 (0.00%)      2/128 (1.56%)    
Gastrointestinal disorders     
Duodenal stenosis  1 [1]  0/133 (0.00%)  0 1/128 (0.78%)  1
General disorders     
Inflammation  1 [2]  0/133 (0.00%)  0 1/128 (0.78%)  1
Injury, poisoning and procedural complications     
Femoral neck fracture  1  0/133 (0.00%)  0 1/128 (0.78%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (15.1)
[1]
They all resolved during the study and they were all evaluated as ‘Unrelated’ to the study drug.
[2]
system organ class: General disorders and administration site conditions
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Start Oxycodone/Naloxone 10/5mg b.i.d Start Oxycodone/Naloxone 5/2.5mg b.i.d
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   115/133 (86.47%)      104/128 (81.25%)    
Cardiac disorders     
Palpitations  1  1/133 (0.75%)  1 2/128 (1.56%)  2
Ear and labyrinth disorders     
Ear discomfort  1  0/133 (0.00%)  0 1/128 (0.78%)  1
Tinnitus  1  0/133 (0.00%)  0 1/128 (0.78%)  1
Eye disorders     
Eye pain  1  1/133 (0.75%)  1 0/128 (0.00%)  0
Gastrointestinal disorders     
Nausea  1  52/133 (39.10%)  55 46/128 (35.94%)  53
Constipation  1  24/133 (18.05%)  26 21/128 (16.41%)  21
vomiting  1  27/133 (20.30%)  27 16/128 (12.50%)  16
Dyspepsia  1  5/133 (3.76%)  5 2/128 (1.56%)  2
Dry mouth  1  3/133 (2.26%)  3 2/128 (1.56%)  2
Abdominal pain lower  1  0/133 (0.00%)  0 1/128 (0.78%)  1
Diarrhoea  1  1/133 (0.75%)  1 0/128 (0.00%)  0
Duodenal stenosis  1  0/133 (0.00%)  0 1/128 (0.78%)  1
General disorders     
Asthenia  1  2/133 (1.50%)  2 4/128 (3.13%)  4
Oedema  1  1/133 (0.75%)  1 3/128 (2.34%)  3
Chest pain  1  1/133 (0.75%)  1 2/128 (1.56%)  2
Oedema peripheral  1  2/133 (1.50%)  2 1/128 (0.78%)  1
Inflammation  1  0/133 (0.00%)  0 1/128 (0.78%)  1
Pain  1  1/133 (0.75%)  1 0/128 (0.00%)  0
Pyrexia  1  1/133 (0.75%)  1 0/128 (0.00%)  0
Infections and infestations     
Gastroenteritis  1  0/133 (0.00%)  0 1/128 (0.78%)  1
Nasopharyngitis  1  1/133 (0.75%)  1 0/128 (0.00%)  0
Injury, poisoning and procedural complications     
Femoral neck fracture  1  0/133 (0.00%)  0 1/128 (0.78%)  1
Metabolism and nutrition disorders     
Decreased appetite  1  5/133 (3.76%)  5 2/128 (1.56%)  2
Musculoskeletal and connective tissue disorders     
Bone disorder  1  1/133 (0.75%)  1 0/128 (0.00%)  0
Joint swelling  1  0/133 (0.00%)  0 1/128 (0.78%)  1
Muscle spasms  1  1/133 (0.75%)  1 0/128 (0.00%)  0
Nervous system disorders     
Dizziness  1  32/133 (24.06%)  34 29/128 (22.66%)  29
Somnolence  1  21/133 (15.79%)  22 26/128 (20.31%)  27
Headache  1  15/133 (11.28%)  16 8/128 (6.25%)  10
Paraesthesia  1  2/133 (1.50%)  2 2/128 (1.56%)  2
Mental impairment  1  0/133 (0.00%)  0 2/128 (1.56%)  2
Dysaesthesia  1  1/133 (0.75%)  1 0/128 (0.00%)  0
Essential tremor  1  0/133 (0.00%)  0 1/128 (0.78%)  1
Lethargy  1  0/133 (0.00%)  0 1/128 (0.78%)  1
Psychiatric disorders     
Insomnia  1  6/133 (4.51%)  6 2/128 (1.56%)  2
Renal and urinary disorders     
Dysuria  1  4/133 (3.01%)  4 3/128 (2.34%)  3
Reproductive system and breast disorders     
Vaginal haemorrhage  1  0/133 (0.00%)  0 2/128 (1.56%)  2
Respiratory, thoracic and mediastinal disorders     
Dysphonia  1  0/133 (0.00%)  0 3/128 (2.34%)  3
Rhinorrhoea  1  1/133 (0.75%)  1 2/128 (1.56%)  2
Dyspnoea  1  0/133 (0.00%)  0 2/128 (1.56%)  2
Oropharyngeal pain  1  0/133 (0.00%)  0 1/128 (0.78%)  1
Skin and subcutaneous tissue disorders     
Pruritus  1  20/133 (15.04%)  21 17/128 (13.28%)  17
Urticaria  1  7/133 (5.26%)  7 0/128 (0.00%)  0
Erythema  1  0/133 (0.00%)  0 1/128 (0.78%)  1
Rash macular  1  1/133 (0.75%)  1 0/128 (0.00%)  0
Vascular disorders     
Hyperaemia  1  0/133 (0.00%)  0 1/128 (0.78%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (15.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Hoseong Lee
Organization: Asan Medical Center
Phone: 82-2-3010-3521
Responsible Party: Mundipharma Korea Ltd
ClinicalTrials.gov Identifier: NCT01811186     History of Changes
Other Study ID Numbers: OXN12-KR-403
First Submitted: March 12, 2013
First Posted: March 14, 2013
Results First Submitted: May 31, 2016
Results First Posted: March 10, 2017
Last Update Posted: March 10, 2017