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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fentanyl / Placebo | Experimental | 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fentanyl Ethypharm | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Summed Pain Intensity Difference at 30 minutes (SPID30). | 30 minutes post dose |
| Measure | Description | Time Frame |
|---|---|---|
| SPID at 3, 6, 10, 15 and 60 minutes post-dosing | 3, 6, 10, 15 and 60 minutes post-dosing | |
| SPID at 15 and 30 minutes according to the pathophysiology of the pain (neuropathic, nociceptive) | 15 and 30 minutes post dose |
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Inclusion criteria:
Main exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pain Care Units | Prague | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24508417 | Derived | Novotna S, Valentova K, Fricova J, Richterova E, Harabisova S, Bullier F, Trinquet F; ETHYFYL Study Group. A randomized, placebo-controlled study of a new sublingual formulation of fentanyl citrate (fentanyl ethypharm) for breakthrough pain in opioid-treated patients with cancer. Clin Ther. 2014 Mar 1;36(3):357-67. doi: 10.1016/j.clinthera.2014.01.006. Epub 2014 Feb 5. |
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| ID | Term |
|---|---|
| D059390 | Breakthrough Pain |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Pain Intensity Difference at 3, 6, 10, 15, 30 and 60 minutes after dosing | 3, 6, 10, 15, 30 and 60 minutes after dosing |
| Pain Relief at 3, 6, 10, 15, 30 and 60 minutes after dosing | 3, 6, 10, 15, 30 and 60 minutes after dosing |
| The proportion of episodes of BTP that required rescue medication | 15 and 30 minutes post dose |
| the proportion of episodes with more than 33% and 50% of improvement in Pain Intensity scores | 15 and 30 minutes post dose |
| Recording of safety data | Adverse events, vital signs, urinary pregnancy test | During all the study duration, an expected average of 8 weeks |