Status and phase
Conditions
Treatments
About
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.
Full description
The randomisation (1:1) will consider the two titration methadone switching methods:
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
146 participants in 2 patient groups
Loading...
Central trial contact
Shimsi Lefki, Dr
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal