Status:
COMPLETED
An Interventional Study to Compare the Efficacy and Tolerability With Targin® in Non-malignant Chronic Pain (GLORY)
Lead Sponsor:
Mundipharma Korea Ltd
Conditions:
Chronic Pain
Eligibility:
All Genders
20-80 years
Phase:
PHASE4
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 advers...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
261 Patients enrolled
Trial Details
Trial ID
NCT01811186
Start Date
December 1 2012
End Date
June 1 2014
Last Update
March 10 2017
Active Locations (1)
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1
AMC
Seoul, South Korea