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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Mundipharma Korea Ltd
ClinicalTrials.gov Identifier:
NCT01811186
First received: March 12, 2013
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

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 EQ-5D
    • To assess physician's overall satisfaction
    • To assess subject's overall satisfaction
    • To assess safety

Condition Intervention Phase
Chronic Pain
Drug: oxycodone/naloxone
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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)

Resource links provided by NLM:


Further study details as provided by Mundipharma Korea Ltd:

Primary Outcome Measures:
  • drop-out rate caused by adverse event [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    To assess the drop-out rate caused by adverse event* after 6 weeks treatment


Estimated Enrollment: 260
Study Start Date: December 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
oxycodone/naloxone
oral, TID
Drug: oxycodone/naloxone
oral, TID
Other Name: Targin

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 (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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01811186

Locations
Korea, Republic of
AMC
Seoul, Korea, Republic of
Sponsors and Collaborators
Mundipharma Korea Ltd
  More Information

No publications provided

Responsible Party: Mundipharma Korea Ltd
ClinicalTrials.gov Identifier: NCT01811186     History of Changes
Other Study ID Numbers: OXN12_KR_403
Study First Received: March 12, 2013
Last Updated: December 9, 2013
Health Authority: Korea: Food and Drug Administration
Korea: Institutional Review Board

Keywords provided by Mundipharma Korea Ltd:
moderate to severe non-malignant chronic pain

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Oxycodone
Naloxone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Narcotic Antagonists

ClinicalTrials.gov processed this record on September 18, 2014