Pain Related to CancerPhase 3EQUIMETH2NCT01793480
Evaluation of the Efficacy and Safety of Two Methadone Titration Methods for the Treatment of Cancer-related Pain With Inadequate Pain Relief or Intolerable Side Effects When Treated With Level 3 Opioids.
A Phase 3 study testing Methadone in people with Pain Related to Cancer, run by RECORDATI GROUP at 16 sites in France.
Trial summary
This is a multicentric, randomized, open-label, phase IIIb national study, to evaluate the clinical effects (success/failure) of methadone for the treatment of cancer-related-pain in patients with inadequate pain relief or intolerable side effects when treated with level 3 opioid. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain Related to Cancer
- What is being tested?
- Methadone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 16 sitesFrance
- Study dates
- 5 Jan 2012to 31 Aug 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient of at least 18 years of age
- Patient suffering from cancer disease, undergoing chemotherapy treatment or not, hospitalised or requiring hospitalisation
- Patient presenting nociceptive or mixed pains inadequately relieved with level 3 opioids (morphine, oxycodone, transdermal fentanyl, hydromorphone) with a numeric pain scale score ≥5 evidence-based or presenting intolerable side effects with level 3 opioids
- Patient undergoing level 3 opioid treatment (morphine sulphate or morphine chlorhydrate or fentanyl or oxycodone or hydromorphone)
- Patient presenting a good understanding of the study objectives and able to give his/her written consent
- Patient able to communicate with the investigator or his representative
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- Patient available during the whole course of the study and agreeing the study requirements
- Patient with Social Insurance
- Patient having received patient's information form, orally informed and having signed the consent form
Who cannot join
- Patient in terminal cancer disease (life expectancy less than 2 months) according to investigator's judgement
- Patient treated with a medication that may result in an interaction with methadone, such as: antiarrythmic treatments (Ia or III), erythromycin, spiramycin, intravenous vincamin
- Patient receiving opioid treatment for any other reason than pain
- Patient unable to swallow the study treatment
- Patient presenting contra-indication to the use of methadone
- Patient having a decompensated respiratory failure or a severe hepatic disease
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- Patient having a known hypersensitivity to methadone
- Patient presenting QT interval prolongation on ECG results
- Patient receiving a concomitant treatment with a morphine-type agonist-antagonist medication (pentazocine, buprenorphine, nalbuphine) or with sultopride, or with morphinic antagonist (naltrexone)
- Patient treated by analgesic radiotherapy within 15 days before inclusion
- Patient participating or having participated in another clinical trial with a new therapy within one month before inclusion
- Patient with a history of substance abuse
- For woman with childbearing potential: pregnancy or breastfeeding.
- Forfeiture of freedom or under guardianship
- Past history of suicidal attempts
- Patient likely not to respect the study conditions and/or study discontinuation criteria according to investigator's judgement
- Patient presenting any other medical condition or illness or clinically significant abnormal findings on the physical examination at screening that, in the opinion of the Investigator, make the patient unsuitable for the study or put the patient at additional risk.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
France16 sites
Investigational Site 10
Amiens
Investigational Site 06
Bayonne
Investigational Site 13
Caen
Investigational Site 03
Gap
Investigational Site 11
Le Chesnay
Investigational Site 07
Lille
Investigational Site 16
Lyon
Investigational Site 12
Nice
Investigational Site 14
Paris
Investigational Site 02
Pierre-Bénite
Investigational Site 05
Reims
Investigational site 08
Strasbourg
Investigational Site 17
Suresnes
Investigational Site 01
Tarbes
Investigational Site 04
Toulouse
Investigational Site 15
Villejuif
About this study
Official title: Phase IIIb Evaluation of the Efficacy and Safety of Two Methadone Titration Methods for the Treatment of Cancer-related Pain With Inadequate Pain Relief or Intolerable Side Effects When Treated With Level 3 Opioids.
This is a multicentric, randomized, open-label, phase IIIb national study, to evaluate the clinical effects (success/failure) of methadone for the treatment of cancer-related-pain in patients with inadequate pain relief or intolerable side effects when treated with level 3 opioid.
Principal objective is to compare the clinical effects (success/failure) of two methods of methadone titration in patients with cancer-related pain inadequately relieved or with intolerable side effects after treatment with level 3 opioid.
Secondary objectives are : Overall safety of methadone during the study, to describe the patients' characteristics, to describe the effects of methadone on pain relief, to describe the methadone administration, to evaluate patient's quality of life, to evaluate the prescriber's opinion regarding the handling of methadone initiation.
Read the detailed description
The randomisation (1:1) will consider the two titration methadone switching methods:
- Group A: patient-controlled dose of methadone with no overlapping with the previous opioid treatment
- Group B: fixed-dose of methadone with overlapping with the previous opioid treatment
Study Description:
Screening visit (Visit 1) within 48 hours before the inclusion Inclusion visit (Visit2) and randomisation on Day 1 Visit 3 from Day 2 to Day 7 (hospitalisation for all patients). Four follow-up visits on Day 14 (Visit 4), Day 21(Visit 5), Day 28 (Visit 6), Day 42 (Visit 7) End of study visit on Day 56 Follow-up phone contact on Day 84.
- Conditions
- Pain Related to Cancer
- Being tested
- Methadone
- Keywords
- Methadone in cancer pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethadoneDrug
| Study group | Role | What they receive |
|---|---|---|
| patient-controlled dose of methadone | Experimental | The titration will be done on the patient's request (patient-controlled dose of methadone), with no overlapping with the previous opioid treatment, under the investigator's supervision. Receives: Drug: Methadone |
| fixed-dose of methadone | Experimental | The titration will be done with fixed-dose of methadone, on a progressive switch with overlapping with the previous opioid treatment, to avoid withdrawal syndrome when the opioid is discontinued. Receives: Drug: Methadone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binary main criterion based on success/failure rate related to methadone switch on Day 4.
The success is defined as the adequate pain relief on Day 4 and no occurrence of overdose between Day 1 and Day 4. All unmet definition of success will be considered as a failure.
The adequate pain relief is defined as the composite criterion:
- Decrease of at least 2 points on the pain numeric scale from 0 (no pain) to 10 (unacceptable pain) evaluated on Day 4 when compared to the pain numeric scale score at baseline,
- And a pain numeric scale score <5 during two consecutive days (between Day 1 and Day 4)
Measured: Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study start5 Jan 2012
- Primary completion6 May 2014
- Study completion31 Aug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain Related to CancerStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- RECORDATI GROUP
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01793480
- Sponsor's protocol ID
- 2011-004609-26
- Acronym
- EQUIMETH2
- Status last verified
- Oct 2024
- First submitted
- 14 Feb 2013
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIIb Evaluation of the Efficacy and Safety of Two Methadone Titration Methods for the Treatment of Cancer-related Pain With Inadequate Pain Relief or Intolerable Side Effects When Treated With Level 3 Opioids.
- ClinicalTrials.gov ID
- NCT01793480
- Acronym / sponsor ID
- EQUIMETH2 / 2011-004609-26
- Conditions
- Pain Related to Cancer
- Keywords
- Methadone in cancer pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- RECORDATI GROUPIndustry (pharma, biotech, devices)
- Study start
- 5 Jan 2012 (actual)
- Primary completion
- 6 May 2014 (actual)
- Study completion
- 31 Aug 2014 (actual)
- First posted
- 15 Feb 2013 (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.
This is a multicentric, randomized, open-label, phase IIIb national study, to evaluate the clinical effects (success/failure) of methadone for the treatment of cancer-related-pain in patients with inadequate pain relief or intolerable side effects when treated with level 3 opioid.
Principal objective is to compare the clinical effects (success/failure) of two methods of methadone titration in patients with cancer-related pain inadequately relieved or with intolerable side effects after treatment with level 3 opioid.
Secondary objectives are : Overall safety of methadone during the study, to describe the patients' characteristics, to describe the effects of methadone on pain relief, to describe the methadone administration, to evaluate patient's quality of life, to evaluate the prescriber's opinion regarding the handling of methadone initiation.
Detailed description
The randomisation (1:1) will consider the two titration methadone switching methods:
- Group A: patient-controlled dose of methadone with no overlapping with the previous opioid treatment
- Group B: fixed-dose of methadone with overlapping with the previous opioid treatment
Study Description:
Screening visit (Visit 1) within 48 hours before the inclusion Inclusion visit (Visit2) and randomisation on Day 1 Visit 3 from Day 2 to Day 7 (hospitalisation for all patients). Four follow-up visits on Day 14 (Visit 4), Day 21(Visit 5), Day 28 (Visit 6), Day 42 (Visit 7) End of study visit on Day 56 Follow-up phone contact on Day 84.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient-controlled dose of methadone | Experimental | Drug: MethadoneThe titration will be done on the patient's request (patient-controlled dose of methadone), with no overlapping with the previous opioid treatment, under the investigator's supervision. |
| fixed-dose of methadone | Experimental | Drug: MethadoneThe titration will be done with fixed-dose of methadone, on a progressive switch with overlapping with the previous opioid treatment, to avoid withdrawal syndrome when the opioid is discontinued. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adult patient of at least 18 years of age
- Patient suffering from cancer disease, undergoing chemotherapy treatment or not, hospitalised or requiring hospitalisation
- Patient presenting nociceptive or mixed pains inadequately relieved with level 3 opioids (morphine, oxycodone, transdermal fentanyl, hydromorphone) with a numeric pain scale score ≥5 evidence-based or presenting intolerable side effects with level 3 opioids
- Patient undergoing level 3 opioid treatment (morphine sulphate or morphine chlorhydrate or fentanyl or oxycodone or hydromorphone)
- Patient presenting a good understanding of the study objectives and able to give his/her written consent
Key exclusion criteria (17 listed)
- Patient in terminal cancer disease (life expectancy less than 2 months) according to investigator's judgement
- Patient treated with a medication that may result in an interaction with methadone, such as: antiarrythmic treatments (Ia or III), erythromycin, spiramycin, intravenous vincamin
- Patient receiving opioid treatment for any other reason than pain
- Patient unable to swallow the study treatment
- Patient presenting contra-indication to the use of methadone
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 |
|---|---|---|
| Methadone | Drug | fixed-dose of methadone, patient-controlled dose of methadone |
Primary outcome
Binary main criterion based on success/failure rate related to methadone switch on Day 4.
Time frame: Day 4
The success is defined as the adequate pain relief on Day 4 and no occurrence of overdose between Day 1 and Day 4. All unmet definition of success will be considered as a failure. The adequate pain relief is defined as the composite criterion: * Decrease of at least 2 points on the pain numeric scale from 0 (no pain) to 10 (unacceptable pain) evaluated on Day 4 when compared to the pain numeric scale score at baseline, * And a pain numeric scale score <5 during two consecutive days (between Day 1 and Day 4)
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 31 Oct 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Methadone in people with Pain Related to Cancer, run by RECORDATI GROUP at 16 sites in France.
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 9 inclusion and 17 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: finished, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in France. 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?
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?
Binary main criterion based on success/failure rate related to methadone switch on Day 4. (time frame: Day 4). 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 31 Oct 2024; AzTrials last refreshed its copy on 8 Nov 2026.