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

Chronic Pain Clinical Trial

Official title:

An Interventional Study to Compare the Efficacy and Tolerability of Current and Slow Titration With Targin® in the Treatment of Moderate to Severe Non-malignant Chronic Pain (GLORY)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01811186
• Other study ID #: OXN12-KR-403
• Status: Completed
• Phase: Phase 4
• First received: March 12, 2013
• Last updated: July 7, 2015
• Start date: December 2012
• Est. completion date: June 2014

Study information

• Verified date: July 2015
• Source: Mundipharma Korea Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug AdministrationKorea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 261
• Est. completion date: June 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Drug:
• oxycodone/naloxone
oral tablets

Locations

Country	Name	City	State
Korea, Republic of	AMC	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Mundipharma Korea Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	drop-out rate caused by adverse event	To assess the drop-out rate caused by adverse event* after 6 weeks treatment	6 weeks	Yes