A Randomized, Placebo-Controlled Study of a New Sublingual Formulation of Fentanyl Citrate (Fentanyl Ethypharm) for Breakthrough Pain in Opioid-Treated Patients With Cancer
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11110%2F14%3A10286829" target="_blank" >RIV/00216208:11110/14:10286829 - isvavai.cz</a>
Alternative codes found
RIV/00064165:_____/14:10286829
Result on the web
<a href="http://dx.doi.org/10.1016/j.clinthera.2014.01.006" target="_blank" >http://dx.doi.org/10.1016/j.clinthera.2014.01.006</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1016/j.clinthera.2014.01.006" target="_blank" >10.1016/j.clinthera.2014.01.006</a>
Alternative languages
Result language
angličtina
Original language name
A Randomized, Placebo-Controlled Study of a New Sublingual Formulation of Fentanyl Citrate (Fentanyl Ethypharm) for Breakthrough Pain in Opioid-Treated Patients With Cancer
Original language description
Background: Oromucosal fentanyl is currently used for the treatment of breakthrough pain (BTP) in opioid-treated cancer patients. Ethypharm developed a sublingual formulation of fentanyl suprabioavailable to oral transmucosal fentanyl citrate with a higher early systemic exposure and a shorter T-max. Objectives: This study evaluated the efficacy and safety profile of fentanyl Ethypharm (FE) in relieving BTP in opioid-treated cancer patients. Methods: Opioid-treated adult cancer patients, experiencing 1to 4 episodes of BTP per day, were included in the study. After an open-label titration period to identify an optimal dose that would provide adequate pain relief for 2 consecutive episodes of BTP with an acceptable level of adverse events, patients wererandomly assigned to a double-blind, placebo-controlled, crossover period with 1 of 13 prespecified sequences of 9 tablets (6 tablets of FE of the dose identified during the open-label titration and 3 placebo). Pain intensity and pain re
Czech name
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Czech description
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Classification
Type
J<sub>x</sub> - Unclassified - Peer-reviewed scientific article (Jimp, Jsc and Jost)
CEP classification
FR - Pharmacology and apothecary chemistry
OECD FORD branch
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Result continuities
Project
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Continuities
N - Vyzkumna aktivita podporovana z neverejnych zdroju
Others
Publication year
2014
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
Clinical Therapeutics
ISSN
0149-2918
e-ISSN
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Volume of the periodical
36
Issue of the periodical within the volume
3
Country of publishing house
US - UNITED STATES
Number of pages
11
Pages from-to
357-367
UT code for WoS article
000333661400008
EID of the result in the Scopus database
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