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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Safety set: 261 patients were enrolled. ITT set was 258, 3 patients of the 261 patients deviated from inclusion/exclusion criteria.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Start Oxycodone/Naloxone 10/5mg b.i.d. 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 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.

Participant Flow:   Overall Study
    Start Oxycodone/Naloxone 10/5mg b.i.d.   Start Oxycodone/Naloxone 5/2.5mg b.i.d
STARTED   132   126 
COMPLETED   61   64 
NOT COMPLETED   71   62 
Adverse Event                54                38 
Protocol Violation                5                6 
Withdrawal by Subject                5                10 
Lack of Efficacy                3                6 
Lost to Follow-up                4                2 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety set: 261 ITT set: 258(3 patients were deviated inclusion/exclusion criteria among 261)

Reporting Groups
  Description
Start Oxycodone/Naloxone 10/5mg b.i.d 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 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 Total of all reporting groups

Baseline Measures
   Start Oxycodone/Naloxone 10/5mg b.i.d   Start Oxycodone/Naloxone 5/2.5mg b.i.d   Total 
Overall Participants Analyzed 
[Units: Participants]
 132   126   258 
Age 
[Units: Participants]
Count of 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 
[Units: Years]
Mean (Standard Deviation)
 60.63  (9.69)   61.15  (11.94)   60.88  (10.83) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      81  61.4%      84  66.7%      165  64.0% 
Male      51  38.6%      42  33.3%      93  36.0% 
Region of Enrollment 
[Units: Participants]
     
Korea, Republic of   132   126   258 


  Outcome Measures

1.  Primary:   Drop-out Rate Caused by Adverse Event After 6 Weeks Treatment   [ Time Frame: 6 weeks ]

2.  Secondary:   The Drop-out Rate Due to an Adverse Event After 1 Week Treatment With the Study Drug.   [ Time Frame: 1 week ]

3.  Secondary:   The Change of Pain Intensity Scores(NRS) From Baseline After 6 Weeks Treatment With the Study.   [ Time Frame: 6 weeks ]

4.  Secondary:   Change of Quality of Life (EQ-5D) Score After 6 Weeks Treatment With the Study Drug   [ Time Frame: 6 weeks ]

5.  Secondary:   Assessment of Investigator’s Overall Satisfaction After 6 Weeks Treatment With the Study Drug   [ Time Frame: 6 weeks ]

6.  Secondary:   Assessment of Subject’s Overall Satisfaction After 6 Weeks Treatment With the Study Drug   [ Time Frame: 6weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: hosng@amc.seoul.kr



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