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

Primary Purpose

Chronic Pain

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Oxycodone Naloxone Combination
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Spinal Cord Injury, Traumatic Spinal Cord Injury, Targin®, Opioids, Naloxone, Opioid Induced Constipation, Oxycodone-Naloxone

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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

Sites / Locations

  • University of British Columbia

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Oxycodone Naloxone Combination

Arm Description

Open-Label

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change from Baseline in management of neurogenic bowel and opioid induced constipation
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 in total daily dose of medications to manage pain related to spinal cord injury
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 in total daily dose of medications to manage bowel routine
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.
Change from Baseline of autonomic function.
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.
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.
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 effects.
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 of opioid side effect cognitive function.
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.

Full Information

First Posted
May 1, 2017
Last Updated
December 8, 2021
Sponsor
University of British Columbia
Collaborators
Purdue Pharma, Canada, International Collaboration on Repair Discoveries, Vancouver Coastal Health
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1. Study Identification

Unique Protocol Identification Number
NCT03179475
Brief Title
Targin® for Chronic Pain Management in Patients With Spinal Cord Injury
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?
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
September 5, 2019 (Actual)
Primary Completion Date
November 29, 2021 (Actual)
Study Completion Date
November 29, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
Purdue Pharma, Canada, International Collaboration on Repair Discoveries, Vancouver Coastal Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Spinal Cord Injury, Traumatic Spinal Cord Injury, Targin®, Opioids, Naloxone, Opioid Induced Constipation, Oxycodone-Naloxone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oxycodone Naloxone Combination
Arm Type
Other
Arm Description
Open-Label
Intervention Type
Drug
Intervention Name(s)
Oxycodone Naloxone Combination
Other Intervention Name(s)
Targin®
Intervention Description
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: 5 mg oxycodone hydrocholoride / 2.5 mg naloxone hydrochloride 10 mg oxycodone hydrocholoride / 5 mg naloxone hydrochloride 20 mg oxycodone hydrocholoride / 10 mg naloxone hydrochloride 40 mg oxycodone hydrocholoride / 20 mg naloxone hydrochloride
Primary Outcome Measure Information:
Title
Change in management of pain related to spinal cord injury
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Change from Baseline in management of neurogenic bowel and opioid induced constipation
Description
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.
Time Frame
8 weeks
Title
Change from Baseline in total daily dose of medications to manage pain related to spinal cord injury
Description
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.
Time Frame
8 weeks
Title
Change from Baseline in total daily dose of medications to manage bowel routine
Description
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.
Time Frame
8 weeks
Title
Change from Baseline of autonomic function.
Description
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.
Time Frame
8 weeks
Title
Change from Baseline of quality of life.
Description
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.
Time Frame
8 weeks
Title
Change from Baseline in depressive symptoms.
Description
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.
Time Frame
8 weeks
Title
Change from baseline of opioid side effects.
Description
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.
Time Frame
8 weeks
Title
Change from baseline of opioid side effect cognitive function.
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrei Krassioukov, MD,PhD,FRCPC
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
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.

Learn more about this trial

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

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