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.

NCT01793480 | Completed Phase 3

• 1 other identifier: 2011-004609-26
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 16

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.

Conditions

Pain Related to Cancer

Keywords

Methadone in cancer pain

Outcome Measures

Primary Outcomes (1)

• 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)

  Day 4

Study Arms (2)

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.

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.

Drug: Methadone

Interventions

Methadone DRUG

fixed-dose of methadone; patient-controlled dose of methadone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• RECORDATI GROUP: lead

Study Sites (16)

Investigational Site 10

Amiens, France

Location

Investigational Site 06

Bayonne, France

Location

Investigational Site 13

Caen, France

Location

Investigational Site 03

Gap, France

Location

Investigational Site 11

Le Chesnay, France

Location

Investigational Site 07

Lille, France

Location

Investigational Site 16

Lyon, France

Location

Investigational Site 12

Nice, France

Location

Investigational Site 14

Paris, France

Location

Investigational Site 02

Pierre-Bénite, France

Location

Investigational Site 05

Reims, France

Location

Investigational site 08

Strasbourg, France

Location

Investigational Site 17

Suresnes, France

Location

Investigational Site 01

Tarbes, France

Location

Investigational Site 04

Toulouse, France

Location

Investigational Site 15

Villejuif, France

Location

MeSH Terms

Interventions

Methadone

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2013
• First Posted: February 15, 2013
• Study Start: January 5, 2012
• Primary Completion: May 6, 2014
• Study Completion: August 31, 2014
• Last Updated: October 31, 2024

Record last verified: 2024-10

Locations

FR (16)