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

Phase 4

Completed

• Conditions: Chronic Pain
• Interventions: Drug: Oxycodone Naloxone Combination

• Registration Number: NCT03179475
• Lead Sponsor: University of British Columbia

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.

Study Timeline

• Study First Submitted: 2017-05-01
• Study First Submitted QC: 2017-06-05
• Study First Posted: 2017-06-07
• Study Start: 2019-09-05
• Primary Completion: 2021-11-29
• Study Completion: 2021-11-29
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-08
• Last Update Posted: 2021-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oxycodone Naloxone Combination	Oxycodone Naloxone Combination	Open-Label

Primary Outcome Measures

Name	Time	Method
Change in management of pain related to spinal cord injury	8 weeks	Evaluation and assessment of pain is the primary objective. The evaluation tool "Revised McGill Short Form Pain" Questionnaire (SF-MPQ-2) is one of the most frequently used measures in clinical and research contexts to evaluate pain.; The primary outcome measure is a change from baseline in SF-MPQ-2 score at 8 weeks.

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in management of neurogenic bowel and opioid induced constipation	8 weeks	Evaluation and assessment of changes in neurogenic bowel and opioid-induced constipation is a secondary objective. Neurogenic bowel dysfunction, including constipation will be assessed using the evaluation tools "Neurogenic Bowel Dysfunction (NBD) score", the "Patient Assessment of Constipation-Symptoms (PAC-SYM)" score, and the "Patient Assessment of Constipation- Quality of Life (PAC-QOL)" score.; The secondary outcome measure is a change from baseline in NBD, PAC-SYM, and PAC-QOL scores at 8 weeks.
Change from Baseline of autonomic function.	8 weeks	Evaluation and assessment of changes in autonomic function is a secondary objective. Global autonomic function will be assessed with the neurological classification of spinal cord injury autonomic assessment form evaluation tool "International Standards on documentation of remaining Autonomic Function after Spinal Cord Injury (ISAFSCI)".; The secondary outcome measure is a change from baseline in ISAFSCI score at 8 weeks.
Change from Baseline of quality of life.	8 weeks	Evaluation and assessment of changes in quality of life is a secondary objective. Quality of life will be assessed with the evaluation tool "Short Form Health Survey (SF-36)".; The secondary outcome measure is a change from baseline in SF-36 QOL score at 8 weeks.
Change from Baseline in depressive symptoms.	8 weeks	Evaluation and assessment of depressive symptoms is a secondary objective. Depressive symptoms will be assessed with the evaluation tool "Patient Health Questionnaire (PHQ-9)".; The secondary outcome measure is a change from baseline in PHQ-9 score at 8 weeks.
Change from baseline of opioid side effect cognitive function.	8 weeks	Evaluation and assessment of opioid side effects is a secondary objective. Cognitive function is of special interest to us; we will evaluate cognitive function using the evaluation tool "Montreal Cognitive Assessment (MoCA) scale".; The secondary outcome measure is a change from baseline in MoCA score at 8 weeks.
Change from Baseline in total daily dose of medications to manage pain related to spinal cord injury	8 weeks	Evaluation and assessment of changes in the total daily dose of opioid medications required by individuals with spinal cord injury is a secondary objective.; The secondary outcome measure is a change from baseline in total daily dose of opioid medications required by individuals with spinal cord injuries at 8 weeks.
Change from baseline of opioid side effects.	8 weeks	Evaluation and assessment of opioid side effects is a secondary objective. The measure will be incidence of side effect in those treated with the study drug.
Change from Baseline in total daily dose of medications to manage bowel routine	8 weeks	Evaluation and assessment of changes in the total daily dose of bowel routine medications required by individuals with spinal cord injury is a secondary objective.; The secondary outcome measure is a change from baseline in the total daily dose of bowel routine medications required by individuals with spinal cord injuries at 8 weeks.

Trial Locations

Locations (1)

University of British Columbia; 🇨🇦 Vancouver, British Columbia, Canada