NCT03179475

Targin® for Chronic Pain Management in Patients With Spinal Cord Injury

An Open-label, Single Centre Prospective Cohort Study to Determine the Effectiveness and Safety of Targin® for Pain Management and Opioid-induced Constipation in Patients With Spinal Cord Injury: Can we Improve Pain and Ameliorate Secondary Complications of Opioid Treatment?

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: University of British Columbia · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The study will be investigating the effectiveness of oxycodone-naloxone (brand name Targin®) at treating chronic pain in individuals with spinal cord injury. The goal of the study is to compare the effectiveness of Targin® at treating chronic pain in individuals with sub-acute and chronic spinal cord injury compared to opioid medication that is not compounded with naloxone.

Detailed description

This is a Phase 4, open-label prospective cohort study investigating Targin® for treating chronic pain in individuals with sub-acute and chronic spinal cord injuries. Targin® is currently approved for use by Health Canada for the treatment of moderate-to-severe chronic pain and will be investigated here for the management of moderate-to-severe chronic pain following spinal cord injury. The effectiveness and safety of opioid use for individuals with spinal cord injury has yet to be thoroughly investigated. Additionally, individuals with spinal cord injury using opioids may have the superimposed effect of neurogenic bowel and opioid induced constipation, which may cause increased frequency and severity of autonomic dysreflexia episodes, reduced quality of life, depressive symptoms, and discontinuation of opioid medication. Targin® has the potential to ameliorate these symptoms and improve treatment adherence in individuals with spinal cord injury.

Conditions

• Chronic Pain

Interventions

Type	Name	Description
DRUG	Oxycodone Naloxone Combination	A flexible dosing schedule will be used in this study. The dose and schedule will be based on the minimal amount of medication required to manage pain related to spinal cord injury. The dose and/or frequency will be titrated to the individual's pain level at the discretion of their regular attending physician and/or investigator. Oxycodone-Naloxone is available in the following oral dosages: 1. 5 mg oxycodone hydrocholoride / 2.5 mg naloxone hydrochloride 2. 10 mg oxycodone hydrocholoride / 5 mg naloxone hydrochloride 3. 20 mg oxycodone hydrocholoride / 10 mg naloxone hydrochloride 4. 40 mg oxycodone hydrocholoride / 20 mg naloxone hydrochloride

Timeline

• Start date: 2019-09-05
• Primary completion: 2021-11-29
• Completion: 2021-11-29
• First posted: 2017-06-07
• Last updated: 2021-12-10

Locations

1 site across 1 country: Canada