Evaluation of the Efficacy and Safety of Two Methadone Ti... | NCT01793480

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Methadone	Drug		fixed-dose of methadone patient-controlled dose of methadone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Eligibility Module

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.

Facility	Status	City	State	ZIP	Country	Contacts
Investigational Site 10		Amiens			France
Investigational Site 06

ID	Term
D007659	Ketones
D009930	Organic Chemicals