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

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ClinicalTrials.gov Identifier: NCT03179475
Recruitment Status : Not yet recruiting
First Posted : June 7, 2017
Last Update Posted : November 1, 2018
Sponsor:
Collaborators:
Purdue Pharma LP
International Collaboration On Repair Discoveries (ICORD)
Vancouver Coastal Health
Information provided by (Responsible Party):
Andrei Krassioukov, 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.

Condition or disease Intervention/treatment Phase
Chronic Pain Drug: Oxycodone Naloxone Combination Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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?
Estimated Study Start Date : December 15, 2018
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : December 31, 2019


Arm Intervention/treatment
Oxycodone Naloxone Combination
Open-Label
Drug: 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 Name: Targin®




Primary Outcome Measures :
  1. Change in management of pain related to spinal cord injury [ Time Frame: 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 :
  1. Change from Baseline in management of neurogenic bowel and opioid induced constipation [ Time Frame: 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 with the evaluation tool "Neurogenic Bowel Dysfunction (NBD) score".

    The secondary outcome measure is a change from baseline in NBD score at 8 weeks.


  2. Change from Baseline in total daily dose of medications to manage pain related to spinal cord injury [ Time Frame: 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.


  3. Change from Baseline in total daily dose of medications to manage bowel routine [ Time Frame: 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.


  4. Change from Baseline of autonomic function. [ Time Frame: 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.


  5. Change from Baseline of quality of life. [ Time Frame: 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.


  6. Change from Baseline in depressive symptoms. [ Time Frame: 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.


  7. Change from baseline of opioid side effects. [ Time Frame: 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.

  8. Change from baseline of opioid side effect cognitive function. [ Time Frame: 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

The inclusion criteria include, but are not limited to, the following:

  • Male or female, 18 - 55 years of age
  • 3 months or more following traumatic 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:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03179475


Contacts
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Contact: Andrea Ramirez, B.Sc. 604-875-8856 aramirez@icord.org

Locations
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Canada, British Columbia
University of British Columbia Not yet recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Andrea Ramirez, B.Sc.    6046758856    aramirez@icord.org   
Principal Investigator: Andrei Krassioukov, MD, PhD, FRCPC         
Sub-Investigator: Michael Berger, MD, PhD         
Sub-Investigator: Michael Negraeff, MD, PhD, RCPSC         
Sponsors and Collaborators
University of British Columbia
Purdue Pharma LP
International Collaboration On Repair Discoveries (ICORD)
Vancouver Coastal Health
Investigators
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Principal Investigator: Andrei Krassioukov, MD, PhD, FRCPC University of British Columbia

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Responsible Party: Andrei Krassioukov, Principal Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT03179475     History of Changes
Other Study ID Numbers: H16-01600
First Posted: June 7, 2017    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Undecided Data collected during the study will be used by the investigator to communicate results of the study to the research community. Data will mostly be communicated as a pooled data set; in the event that individual participant data is communicated, it will be represented with the unique study identifier which does not identify the individual participant.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Andrei Krassioukov, University of British Columbia:
Spinal Cord Injury
Traumatic Spinal Cord Injury
Targin®
Opioids
Naloxone
Opioid Induced Constipation
Oxycodone-Naloxone

Additional relevant MeSH terms:
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Oxycodone
Spinal Cord Injuries
Chronic Pain
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics, Opioid
Naloxone
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists