A Randomized, Placebo-Controlled Study of a New Sublingual Formulation of Fentanyl Citrate (Fentanyl Ethypharm) for Breakthrough Pain in Opioid-Treated Patients With Cancer

Kód výsledku v 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>

Nalezeny alternativní kódy

RIV/00064165:_____/14:10286829

Výsledek na webu

<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>

Jazyk výsledku

angličtina

Název v původním jazyce

A Randomized, Placebo-Controlled Study of a New Sublingual Formulation of Fentanyl Citrate (Fentanyl Ethypharm) for Breakthrough Pain in Opioid-Treated Patients With Cancer

Popis výsledku v původním jazyce

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

Název v anglickém jazyce

A Randomized, Placebo-Controlled Study of a New Sublingual Formulation of Fentanyl Citrate (Fentanyl Ethypharm) for Breakthrough Pain in Opioid-Treated Patients With Cancer

Popis výsledku anglicky

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

Druh

J_x - Nezařazeno - Článek v odborném periodiku (Jimp, Jsc a Jost)

CEP obor

FR - Farmakologie a lékárnická chemie

OECD FORD obor

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Projekt

—

Návaznosti

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Rok uplatnění

2014

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Clinical Therapeutics

ISSN

0149-2918

e-ISSN

—

Svazek periodika

36

Číslo periodika v rámci svazku

3

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

11

Strana od-do

357-367

Kód UT WoS článku

000333661400008

EID výsledku v databázi Scopus

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