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

NCT ID: NCT01811186

Last Updated: 2017-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 261 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2014-06-30

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 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.

Conditions

Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Group A

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

Group Type: OTHER

Oxycodone/naloxone

Intervention Type: DRUG

Oxycodone/naloxone titration

Group B

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.

Group Type: OTHER

Oxycodone/naloxone

Intervention Type: DRUG

Oxycodone/naloxone titration

Interventions

Oxycodone/naloxone

Oxycodone/naloxone titration

Intervention Type: DRUG

Other Intervention Names

Targin

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mundipharma Korea Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hoseong Lee, Dr.

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

AMC

Seoul, , South Korea

Countries

South Korea

Other Identifiers

OXN12-KR-403

Identifier Type: -

Identifier Source: org_study_id