Targin® for Chronic Pain Management in Patients With Spinal Cord Injury
NCT ID: NCT03179475
Last Updated: 2021-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
1 participants
INTERVENTIONAL
2019-09-05
2021-11-29
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Oxycodone Naloxone Combination
Open-Label
Oxycodone Naloxone Combination
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
Interventions
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Oxycodone Naloxone Combination
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Purdue Pharma, Canada
INDUSTRY
International Collaboration on Repair Discoveries
OTHER
Vancouver Coastal Health
OTHER_GOV
University of British Columbia
OTHER
Responsible Party
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Andrei Krassioukov
Principal Investigator
Principal Investigators
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Andrei Krassioukov, MD,PhD,FRCPC
Role: PRINCIPAL_INVESTIGATOR
University of British Columbia
Locations
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University of British Columbia
Vancouver, British Columbia, Canada
Countries
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Other Identifiers
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H16-01600
Identifier Type: -
Identifier Source: org_study_id