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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.

Phase 3
18 Years
Open (Enrolling)
Pain Related to Cancer

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Trial Information

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.

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.

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

- 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

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Binary main criterion based on success/failure rate related to methadone switch on Day 4.

Outcome Description:

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)

Outcome Time Frame:

Day 4

Safety Issue:



France: Agence Nationale de Sécurité du Médicament et des produits de santé

Study ID:




Start Date:

December 2011

Completion Date:

Related Keywords:

  • Pain Related to Cancer
  • Methadone in cancer pain