An Interventional Study to Assess the Efficacy and Safety of Oxycodone/Naloxone in Korean Patients With Spinal Disorders

NCT01811238 | Completed Phase 4 Results

• 1 other identifier: OXN12-KR-401
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study Objectives:

• To assess the pain reduction after 4 weeks treatment from baseline (week 0)
• To assess the EQ-5D
• To assess physician's overall satisfaction
• To assess subject's overall satisfaction
• To assess safety

Conditions

Spinal Disorders

Keywords

spinal disorders

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Pain Intensity of Patient With Spinal Disorder as Measured by NRS.

  NRS-Pain scale assessed the severity of a subject's pain of mean pain over the past 24 hours prior to the visit on a scale of 0 (No pain) and 10 (Worst possible pain). Change = mean score at Week 8/ET minus mean score at Baseline.

  Baseline, 8 week

Secondary Outcomes (5)

• The Change in Quality of Life (EQ-5D) at Week 8 of Treatment With the Study Drug From Baseline

  Baseline, 8 week

• Clinical Global Impression of Change(CGIC)

  Baseline, 8 week

• Change of Pain Intensity in Patient With Spinal Disorder at Week 4 of Treatment With the Study Drug From Baseline

  Baseline, 4 week

• Change From Baseline in Health-related Quality of Life Assessed by EuroQol Visual Analog Scale (EQ-5D VAS)

  Baseline, 8 weeks

• Patient Global Impression of Change(PGIC)

  Baseline, 8week

Study Arms (1)

Oxycodone/Naloxone

EXPERIMENTAL

Single-arm study

Drug: Oxycodone/naloxone

Interventions

Oxycodone/naloxone DRUG

Targin 5mg, 10mg, 20mg up to 40mg b.i.d

Also known as: Targin

Oxycodone/Naloxone

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female ≥ 20 and \<80 years of age
• Patients who have spinal disorders related pain for over 90days
• Patients who have moderate to severe pain intensity which is not controlled with weak opioids or NSAIDs: NRS ≥ 4
• Naïve patients for Oxycodone/Naloxone
• Naïve patients for strong opioid
• Patients who signed a written informed consent form

You may not qualify if:

• 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
• Patients with severe respiratory depression with hypoxia and/or hypercapnoea
• Patients with severe chronic obstructive pulmonary disease
• Patients with cor pulmonale
• Patients with severe bronchial asthma
• Patients who have been diagnosed or is suspected of having paralytic or obstructive ileus.Patients with moderate to severe hepatic impairment
• Targin(R) product contains lactose. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take
• Abnormal aspartate aminotransferase (AST; SGOT), alanine aminotransferase (ALT; SGPT), or alkaline phosphatase levels (\>2.5 times the upper limit of normal, it is allowed \>5 times the upper limit of normal in case of transition in liver) or an abnormal total bilirubin and/or creatinine level (s)(greater than 1.5 times the upper limit of normal), gamma glutamyl transpeptidase (GGT or GGTP) ≥ 3 times the upper limit of normal
• Patients with uncontrolled seizures
• Requiring interventional treatment for pain such as neurodestructive procedure or regional infusion
• Patients with increased intracranial pressure
• In the investigator's opinion, subjects who are receiving hypnotics or central nervous system (CNS) depressants that may pose a risk of additional CNS depression with opioid study medication
• Patients with myxodema, not adequately treated hypothyroidism or Addisons disease

Sponsors & Collaborators

• Mundipharma Korea Ltd: lead

Related Publications (1)

• Hwang CJ, Chung SS, Lee KY, Lee JH, Moon SH, Kim JH, Cho KJ, Ahn JS, Kim DS, Park YS, Park HJ. Analgesic Efficacy and Safety of Prolonged-Release Oxycodone/Naloxone in Korean Patients with Chronic Pain from Spinal Disorders. Clin Orthop Surg. 2018 Mar;10(1):33-40. doi: 10.4055/cios.2018.10.1.33. Epub 2018 Feb 27.

  PMID: 29564045 DERIVED

MeSH Terms

Interventions

Oxycodone; Naloxone

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Dr.Sungsoo Chung
• Organization: Samsung Medical Center

ssc0385@skku.edu

82-3410-1226

Study Officials

• Sung Soo Shung

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2012
• First Posted: March 14, 2013
• Study Start: September 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: July 1, 2013
• Last Updated: May 12, 2016
• Results First Posted: May 12, 2016

Record last verified: 2016-04