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. (EQUIMETH2)

Study Description

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Brief 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.

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.

Condition or disease	Intervention/treatment	Phase
Pain Related to Cancer	Drug: Methadone	Phase 3

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

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	146 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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.
Study Start Date :	December 2011
Estimated Primary Completion Date :	September 2013

Arms and Interventions

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Arm	Intervention/treatment
Experimental: patient-controlled dose of methadone; 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.	Drug: Methadone
Experimental: fixed-dose of methadone; 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.	Drug: Methadone

Outcome Measures

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Primary Outcome Measures :

1. 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)

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• 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
• 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

Exclusion Criteria:

• 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
• 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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Shimsi Lefki, Dr	33145191103	s.lefki@bouchara-recordati.fr

Locations

France
Investigational Site 10	Recruiting
Amiens, France
Investigational Site 06	Recruiting
Bayonne, France
Investigational Site 13	Recruiting
Caen, France
Investigational Site 03	Recruiting
GAP, France
Investigational Site 11	Recruiting
Le Chesnay, France
Investigational Site 07	Recruiting
Lille, France
Investigational Site 16	Recruiting
Lyon, France
Investigational Site 12	Recruiting
Nice, France
Investigational Site 14	Active, not recruiting
Paris, France
Investigational Site 02	Recruiting
Pierre Benite, France
Investigational Site 05	Recruiting
Reims, France
Investigational site 08	Recruiting
Strasbourg, France
Investigational Site 17	Recruiting
Suresnes, France
Investigational Site 01	Recruiting
Tarbes, France
Investigational Site 04	Active, not recruiting
Toulouse, France
Investigational Site 15	Recruiting
Villejuif, France

Sponsors and Collaborators

Laboratoires Bouchara-Recordati

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Laboratoires Bouchara-Recordati
ClinicalTrials.gov Identifier:	NCT01793480 History of Changes
Other Study ID Numbers:	2011-004609-26
First Posted:	February 15, 2013
Last Update Posted:	February 18, 2013
Last Verified:	February 2013

Keywords provided by Laboratoires Bouchara-Recordati:

Methadone in cancer pain

Additional relevant MeSH terms:

Cancer Pain; Pain; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Analgesics, Opioid; Methadone; Narcotics	Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Antitussive Agents; Respiratory System Agents