Additional inclusion criteria for Stage II and
eligibility:
Patients were eligible to be included in Stage II if they: ix)reported experiencing moderate to severe pain; x) had used
strong opioid analgesics for at least one week to relieve pain
associated with incurable malignancy (one-week prior use of opioid
treatment is sufficient duration because it would represent established
opioid treatment and most patients would have developed tolerance after
one week, especially with multiple daily doses totalling >
60 mg of oral morphine or equivalent) and/or patient is on a low dose
opioid regimen and still experiencing pain and is unable to increase the
opioid dose due to poor tolerance as confirmed by the treating principal
investigator; xi) reported pain severity greater than four on a
0-10 Numerical Pain Rating Scale (NPRS) assessment tool.