The purpose of the study is to assess the clinical effectiveness of Fentanyl ETHYPHARM when used to relieve breakthrough pain (BTP) in opioid-treated cancer patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
91
After an open-label titration to identify an optimal dose, patients were randomized to 1 of 13 prespecified sequences of 9 tablets (6 fentanyl and 3 placebo)
Pain Care Units
Prague, Czechia
Summed Pain Intensity Difference at 30 minutes (SPID30).
Time frame: 30 minutes post dose
SPID at 3, 6, 10, 15 and 60 minutes post-dosing
Time frame: 3, 6, 10, 15 and 60 minutes post-dosing
SPID at 15 and 30 minutes according to the pathophysiology of the pain (neuropathic, nociceptive)
Time frame: 15 and 30 minutes post dose
Pain Intensity Difference at 3, 6, 10, 15, 30 and 60 minutes after dosing
Time frame: 3, 6, 10, 15, 30 and 60 minutes after dosing
Pain Relief at 3, 6, 10, 15, 30 and 60 minutes after dosing
Time frame: 3, 6, 10, 15, 30 and 60 minutes after dosing
The proportion of episodes of BTP that required rescue medication
Time frame: 15 and 30 minutes post dose
the proportion of episodes with more than 33% and 50% of improvement in Pain Intensity scores
Time frame: 15 and 30 minutes post dose
Recording of safety data
Adverse events, vital signs, urinary pregnancy test
Time frame: During all the study duration, an expected average of 8 weeks
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