Pain Related to Cancer Clinical Trial
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.
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03558594 -
Hypnosis and Meditation for Cancer Pain
|
N/A |