Clinical trial NCT03179475: Targin® for Chronic Pain Management in Patients With Spinal Cord Injury
Official title: 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?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Pain
Keywords: Spinal Cord Injury
Traumatic Spinal Cord Injury
Targin®
Opioids
Naloxone
Opioid Induced Constipation
Oxycodone-Naloxone
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Purdue Pharma, Canada
name: International Collaboration on Repair Discoveries
name: Vancouver Coastal Health
First posted: 2017-06-07
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility 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

Primary outcomes:
measure: Change in management of pain related to spinal cord injury
timeFrame: 8 weeks
Secondary outcomes:
measure: Change from Baseline in management of neurogenic bowel and opioid induced constipation
timeFrame: 8 weeks
measure: Change from Baseline in total daily dose of medications to manage pain related to spinal cord injury
timeFrame: 8 weeks
measure: Change from Baseline in total daily dose of medications to manage bowel routine
timeFrame: 8 weeks
measure: Change from Baseline of autonomic function.
timeFrame: 8 weeks
measure: Change from Baseline of quality of life.
timeFrame: 8 weeks
measure: Change from Baseline in depressive symptoms.
timeFrame: 8 weeks
measure: Change from baseline of opioid side effects.
timeFrame: 8 weeks
measure: Change from baseline of opioid side effect cognitive function.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Andrei Krassioukov, MD,PhD,FRCPC
role: PRINCIPAL_INVESTIGATOR
References: