Targin® for Chronic Pain Management in Patients With Spinal Cord Injury (NCT03179475) | Clinical Trial Compass
CompletedPhase 4
Targin® for Chronic Pain Management in Patients With Spinal Cord Injury
Canada1 participantsStarted 2019-09-05
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 dep…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in management of pain related to spinal cord injury