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
- Group B: fixed-dose of methadone with overlapping with the previous opioid treatment
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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)
France: Agence Nationale de Sécurité du Médicament et des produits de santé