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

NCT03179475 | Completed Phase 4 DMC

• 1 other identifier: H16-01600
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

Spinal Cord Injury; Traumatic Spinal Cord Injury; Targin®; Opioids; Naloxone; Opioid Induced Constipation; Oxycodone-Naloxone

Outcome Measures

Primary Outcomes (1)

• Change in management of pain related to spinal cord injury

  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.

  8 weeks

Secondary Outcomes (8)

• Change from Baseline in management of neurogenic bowel and opioid induced constipation

  8 weeks

• Change from Baseline in total daily dose of medications to manage pain related to spinal cord injury

  8 weeks

• Change from Baseline in total daily dose of medications to manage bowel routine

  8 weeks

• Change from Baseline of autonomic function.

  8 weeks

• Change from Baseline of quality of life.

  8 weeks

Study Arms (1)

Oxycodone Naloxone Combination

OTHER

Open-Label

Drug: Oxycodone Naloxone Combination

Interventions

Oxycodone Naloxone Combination DRUG

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

Also known as: Targin®

Oxycodone Naloxone Combination

Eligibility Criteria

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

You may qualify if:

• Male or female, 18 - 65 years of age
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead
• Purdue Pharma, Canada: collaborator
• International Collaboration on Repair Discoveries: collaborator
• Vancouver Coastal Health: collaborator

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, V5Z 1M9, Canada

Location

MeSH Terms

Conditions

Chronic Pain; Spinal Cord Injuries; Opioid-Induced Constipation

Interventions

oxycodone naloxone combination

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Constipation; Signs and Symptoms, Digestive; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Andrei Krassioukov, MD,PhD,FRCPC

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 1, 2017
• First Posted: June 7, 2017
• Study Start: September 5, 2019
• Primary Completion: November 29, 2021
• Study Completion: November 29, 2021
• Last Updated: December 10, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)