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

University of British Columbia

Status and phase

Completed

Phase 4

Conditions

Chronic Pain

Treatments

Drug: Oxycodone Naloxone Combination

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03179475

H16-01600

Details and patient eligibility

About

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.

Full 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.

Enrollment

1 patient

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

The inclusion criteria include, but are not limited to, the following:

Male or female, 18 - 65 years of age
3 months or more following spinal cord injury
Chronic pain for more than 3 months
AIS score A, B, C, D with any neurological level of impairment.
Must be taking regular opioid medication prescribed by their physician for a minimum 3 months prior to enrollment in the study
Willing and able to comply with all clinic visits and study-related procedures
Able to understand and complete study-related questionnaires
Must provide informed consent

The exclusion criteria include, but are not limited to, the following:

A daily dose of MME in excess of the maximum 120 MME (control release) or equivalent to the maximum daily dose of Targin per current Investigator Brochure or Product Monograph (80mg oxycodone hydrochloride and 40mg naloxone hydrochloride)
Presence of severe acute medical issue that in the investigator's judgement would adversely affect the patient's participation in the study
Imminent plan by the medical team to wean or discontinue opioid medication for pain management
Moderate and severe forms of renal dysfunction
Clinically significant abnormal laboratory tests as judged by the investigators.
Hypersensitivity or allergy to opioid medication and/or naloxone.
Use of any medication or treatment that in the opinion of the investigator indicates that it is not in the best interest of the patient to participate in this study.
Major depression as indicated by a PHQ-9 score greater than 15 at baseline, or at the discretion of the investigator.
Cognitive impairment as indicated by a MoCA score less than 26, or at the discretion of the investigator.
Patient is a member of the investigational team or his/her immediate family.
Patient does not have a good command of the English language.
Female patients who are breast-feeding or pregnant.
Individuals with documented substance abuse disorder
Individuals within 1-3 months post-acute surgical intervention requiring opioid therapy