Pain, IntractablePhase 3UDOMENCT02687347
Efficacy and Safety of Ultra-low Dose Methadone as Adjuvant Analgesic in Cancer Patients With Pain
A Phase 3 study testing oral methadone and oral morphine in people with Pain, Intractable, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
The research hypothesis of this study is: In patients with moderate to severe cancer related pain, the addition of low dose methadone to an existing opioid significantly reduces pain severity compared to low doses morphine. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain, Intractable
- What is being tested?
- oral methadone and oral morphine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2016to Dec 2018
- Phase
- Phase 3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed of cancer-related pain of more than 3 months duration
- Pain relief during the last week rated unsatisfactory by the patient
- Pain severity during the last week rated moderate (between 4 and 7/10)
- Analgesic therapy must have been stable for 7 days
- Able to understand English or French
- Willing and able to give written informed consent
Who cannot join
- Patients who are currently receiving or have received methadone as analgesic in the last 6 months
- Contraindication to receive methadone (allergy, QTc segment on the ECG>450msec, concurrent treatment with medication that could increase methadone's effects)
- Patients presenting with changes in their cancer status/treatment with potential effects on their pain severity, during the duration of the trial (eg: new metastasis, indication for radiotherapy)
- Patients whose life expectancy is shorter than 2 months
- Patients with cognitive impairment presenting with difficulties understanding the trial and completing the research questionnaires
- Pregnant or lactating women (women of childbearing potential must have negative pregnancy test)
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Alan Edwards Pain Management Unit. Mcgill University Health Centre
Montreal, Quebec, H3G1A4
Jordi Perez, MD, 5149348222, jordi.perez@muhc.mcgill.ca
About this study
Official title: A Double Blind Randomized Clinical Trial to Investigate the Efficacy and Safety of Ultra-low Dose Methadone as Adjuvant Analgesic Therapy in Cancer Patients With Pain
The research hypothesis of this study is: In patients with moderate to severe cancer related pain, the addition of low dose methadone to an existing opioid significantly reduces pain severity compared to low doses morphine.
- Conditions
- Pain, Intractable
- Being tested
- oral methadone, oral morphine
- Medical subject headings
- Pain, Intractable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral methadoneDrug
Oral methadone is the study drug
oral morphineDrug
Oral morphine is the active comparator. It is not a placebo intervention
| Study group | Role | What they receive |
|---|---|---|
| study arm | Experimental | low dose methadone (1-10mg daily) Receives: Drug: oral methadone |
| control arm | Active comparator | low dose morphine (1-10 mg/day) Receives: Drug: oral morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain relief
- Pain item of the Edmonton Symptom Assessment Scale
Measured: 2 months
pain relief
Questions 3 to 6 of the Brief Pain Inventory
Measured: 2 months
Secondary outcomes (1)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0".
prevalence and severity of opioid induced side effects
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionFeb 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, IntractableStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jordi Perez, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02687347
- Sponsor's protocol ID
- 15-369 MP-CUSM
- Acronym
- UDOME
- Status last verified
- Sep 2016
- First submitted
- 8 Feb 2016
- Last updated
- 20 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 1. Demographic, cancer status, pain medication, symptom severity and side effects profile will be collected for each participant throughout the study 2. Data will be collected by clinical interview with research nurse 3. Data will be available to researchers immediately
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind Randomized Clinical Trial to Investigate the Efficacy and Safety of Ultra-low Dose Methadone as Adjuvant Analgesic Therapy in Cancer Patients With Pain
- ClinicalTrials.gov ID
- NCT02687347
- Acronym / sponsor ID
- UDOME / 15-369 MP-CUSM
- Conditions
- Pain, Intractable
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 22 Feb 2016 (estimated)
- 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.
The research hypothesis of this study is: In patients with moderate to severe cancer related pain, the addition of low dose methadone to an existing opioid significantly reduces pain severity compared to low doses morphine.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study arm | Experimental | Drug: oral methadonelow dose methadone (1-10mg daily) |
| control arm | Active comparator | Drug: oral morphinelow dose morphine (1-10 mg/day) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients diagnosed of cancer-related pain of more than 3 months duration
- Pain relief during the last week rated unsatisfactory by the patient
- Pain severity during the last week rated moderate (between 4 and 7/10)
- Analgesic therapy must have been stable for 7 days
- Able to understand English or French
Key exclusion criteria (6 listed)
- Patients who are currently receiving or have received methadone as analgesic in the last 6 months
- Contraindication to receive methadone (allergy, QTc segment on the ECG>450msec, concurrent treatment with medication that could increase methadone's effects)
- Patients presenting with changes in their cancer status/treatment with potential effects on their pain severity, during the duration of the trial (eg: new metastasis, indication for radiotherapy)
- Patients whose life expectancy is shorter than 2 months
- Patients with cognitive impairment presenting with difficulties understanding the trial and completing the research questionnaires
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 |
|---|---|---|
| oral methadoneOral methadone is the study drug | Drug | study arm |
| oral morphineOral morphine is the active comparator. It is not a placebo intervention | Drug | control arm |
Primary outcome
pain relief
Time frame: 2 months
1) Pain item of the Edmonton Symptom Assessment Scale
pain relief
Time frame: 2 months
Questions 3 to 6 of the Brief Pain Inventory
1 secondary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0".
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2016.
- Individual participant dataSharing planned: Yes. 1. Demographic, cancer status, pain medication, symptom severity and side effects profile will be collected for each participant throughout the study 2. Data will be collected by clinical interview with research nurse 3. Data will be available to researchers immediately
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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.
Alan Edwards Pain Management Unit. Mcgill University Health Centre
Montreal, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing oral methadone and oral morphine in people with Pain, Intractable, run by McGill University Health Centre/Research Institute of the McGill University Health Centre 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?
The sponsor lists 6 inclusion and 6 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 20 Sep 2016. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain relief (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Sep 2016.