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

December 8, 2021 updated by: Andrei Krassioukov, University of British Columbia

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?

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • University of British Columbia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: 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 Names:
  • Targin®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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 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.
8 weeks
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.
8 weeks
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.
8 weeks
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.
8 weeks
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.
8 weeks
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.
8 weeks
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 weeks
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.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of British Columbia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Vancouver Coastal Health
International Collaboration on Repair Discoveries
Purdue Pharma, Canada

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Andrei Krassioukov, MD,PhD,FRCPC, University of British Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 5, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 29, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 29, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 1, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 7, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 10, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H16-01600

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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