Chronic PainPhase 4NCT03179475

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

A Phase 4 study testing Oxycodone Naloxone Combination in people with Chronic Pain, run by University of British Columbia at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Chronic Pain
What is being tested?: Oxycodone Naloxone Combination
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1 participants
Where: 1 siteCanada
Study dates: 5 Sep 2019to 29 Nov 2021
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

Canada1 site

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

Other trials in Canada

About this study

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?

Read the 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.

Conditions: Chronic Pain
Being tested: Oxycodone Naloxone Combination
Keywords: Spinal Cord Injury, Traumatic Spinal Cord Injury, Targin®, Opioids, Naloxone, Opioid Induced Constipation, Oxycodone-Naloxone
Medical subject headings: Chronic Pain, Spinal Cord Injuries, Opioid-Induced Constipation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Oxycodone Naloxone CombinationDrug
Also called Targin®
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

Study groups in NCT03179475
Study group	Role	What they receive
Oxycodone Naloxone Combination	Other	Open-Label Receives: Drug: Oxycodone Naloxone Combination

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 8 weeks

Secondary outcomes (8)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 weeks
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.
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Sep 201929 Nov 2021

First posted7 Jun 2017
Study start5 Sep 2019
Primary completion29 Nov 2021
Study completion29 Nov 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic PainStudies of the same condition, open and under way.
More trials run by University of British ColumbiaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 1 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03179475
Sponsor's protocol ID: H16-01600
Status last verified: Dec 2021
First submitted: 1 May 2017
Last updated: 10 Dec 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 10 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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?
ClinicalTrials.gov ID: NCT03179475
Acronym / sponsor ID: H16-01600
Conditions: Chronic Pain
Keywords: Spinal Cord Injury, Traumatic Spinal Cord Injury, Targin®, Opioids, Naloxone, Opioid Induced Constipation, Oxycodone-Naloxone
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 1 participants (actual)
Lead sponsor: University of British ColumbiaUniversity, hospital or other
Collaborators: Purdue Pharma, Canada, International Collaboration on Repair Discoveries, Vancouver Coastal Health
Study start: 5 Sep 2019 (actual)
Primary completion: 29 Nov 2021 (actual)
Study completion: 29 Nov 2021 (actual)
First posted: 7 Jun 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Oxycodone Naloxone Combination	Other	Drug: Oxycodone Naloxone CombinationOpen-Label

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Oxycodone Naloxone CombinationAlso: Targin®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	Drug	Oxycodone Naloxone Combination

Primary outcome

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 secondary outcomes

Change from Baseline in management of neurogenic bowel and opioid induced constipation
Time frame: 8 weeks
Change from Baseline in total daily dose of medications to manage pain related to spinal cord injury
Time frame: 8 weeks
Change from Baseline in total daily dose of medications to manage bowel routine
Time frame: 8 weeks
Change from Baseline of autonomic function.
Time frame: 8 weeks
Change from Baseline of quality of life.
Time frame: 8 weeks
Change from Baseline in depressive symptoms.
Time frame: 8 weeks
Change from baseline of opioid side effects.
Time frame: 8 weeks
Change from baseline of opioid side effect cognitive function.
Time frame: 8 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2021.
Individual participant dataSharing planned: No. 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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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Andrei Krassioukov, MD,PhD,FRCPC principal investigator

University of British Columbia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Oxycodone Naloxone Combination in people with Chronic Pain, run by University of British Columbia at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in management of pain related to spinal cord injury (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03179475.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2021.