Clinical trial NCT01793480: 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.
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain Related to Cancer
Keywords: Methadone in cancer pain
Lead sponsor: RECORDATI GROUP
Sponsor class: INDUSTRY
First posted: 2013-02-15
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Binary main criterion based on success/failure rate related to methadone switch on Day 4.
timeFrame: Day 4
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: Investigational Site 10
city: Bayonne
country: France
facility: Investigational Site 06
city: Caen
country: France
facility: Investigational Site 13
city: GAP
country: France
facility: Investigational Site 03
city: Le Chesnay
country: France
facility: Investigational Site 11
city: Lille
country: France
facility: Investigational Site 07
city: Lyon
country: France
facility: Investigational Site 16
city: Nice
country: France
facility: Investigational Site 12
city: Paris
country: France
facility: Investigational Site 14
city: Pierre Benite
country: France
facility: Investigational Site 02
city: Reims
country: France
facility: Investigational Site 05
city: Strasbourg
country: France
facility: Investigational site 08
city: Suresnes
country: France
facility: Investigational Site 17
city: Tarbes
country: France
facility: Investigational Site 01
city: Toulouse
country: France
facility: Investigational Site 04
city: Villejuif
country: France
facility: Investigational Site 15
Study officials:
References: