Phase 4
Completed N=258
An Interventional Study to Compare the Efficacy and Tolerability With Targin® in Non-malignant Chronic Pain (GLORY)
Source: ClinicalTrials.gov NCT01811186 ↗Enrolled (actual)
258
Serious AEs
0.8%
Results posted
Mar 2017
Primary outcomePrimary: Drop-out Rate Caused by Adverse Event After 6 Weeks Treatment — 40.91; 30.16 percentage of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Drop-out Rate Caused by Adverse Event After 6 Weeks Treatment |
40.91; 30.16 | — |
| SECONDARY The Drop-out Rate Due to an Adverse Event After 1 Week Treatment With the Study Drug. |
28.79; 19.84 | — |
| SECONDARY The Change of Pain Intensity Scores(NRS) From Baseline After 6 Weeks Treatment With the Study. |
-1.62; -1.48 | — |
| SECONDARY Change of Quality of Life (EQ-5D) Score After 6 Weeks Treatment With the Study Drug |
0.14; 0.07 | — |
| SECONDARY Assessment of Investigator's Overall Satisfaction After 6 Weeks Treatment With the Study Drug |
2; 2; 27; 30; 48; 43 | — |
| SECONDARY Assessment of Subject's Overall Satisfaction After 6 Weeks Treatment With the Study Drug |
2; 2; 24; 28; 44; 42 | — |
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
Data sourced from ClinicalTrials.gov (NCT01811186). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.