This HTML5 document contains 48 embedded RDF statements represented using HTML+Microdata notation.

The embedded RDF content will be recognized by any processor of HTML5 Microdata.

Namespace Prefixes

PrefixIRI
dctermshttp://purl.org/dc/terms/
n19http://linked.opendata.cz/resource/domain/vavai/vysledek/RIV%2F61989592%3A15110%2F13%3A33140393%21RIV14-MSM-15110___/
n15http://localhost/temp/predkladatel/
n16http://linked.opendata.cz/resource/domain/vavai/riv/tvurce/
n10http://linked.opendata.cz/resource/domain/vavai/subjekt/
n9http://linked.opendata.cz/ontology/domain/vavai/
shttp://schema.org/
skoshttp://www.w3.org/2004/02/skos/core#
n4http://linked.opendata.cz/ontology/domain/vavai/riv/
n12http://bibframe.org/vocab/
n2http://linked.opendata.cz/resource/domain/vavai/vysledek/
rdfhttp://www.w3.org/1999/02/22-rdf-syntax-ns#
n8http://linked.opendata.cz/ontology/domain/vavai/riv/klicoveSlovo/
n11http://linked.opendata.cz/ontology/domain/vavai/riv/duvernostUdaju/
xsdhhttp://www.w3.org/2001/XMLSchema#
n18http://linked.opendata.cz/ontology/domain/vavai/riv/jazykVysledku/
n6http://linked.opendata.cz/ontology/domain/vavai/riv/aktivita/
n17http://linked.opendata.cz/ontology/domain/vavai/riv/obor/
n5http://linked.opendata.cz/ontology/domain/vavai/riv/druhVysledku/
n14http://reference.data.gov.uk/id/gregorian-year/

Statements

Subject Item
n2:RIV%2F61989592%3A15110%2F13%3A33140393%21RIV14-MSM-15110___
rdf:type
n9:Vysledek skos:Concept
dcterms:description
We report the first phase III placebo-controlled study of the efficacy of the endocannabinoid system modulator delta-9-tetrahydrocannabinol (THC)/cannabidiol (CBD) oromucosal spray to alleviate CNP. A total of 339 patients were randomized to phase A (167 received THC/CBD spray and 172 received placebo). Of those who completed phase A, 58 entered the randomized-withdrawal phase. The primary endpoint of responder analysis at the 30 % level at week 14 of phase A of the study was not met, with 50 % of patients on THC/CBD spray classed as responders at the 30 % level compared to 45 % of patients on placebo (p = 0.234). However, an interim analysis at week 10 showed a statistically significant treatment difference in favor of THC/CBD spray at this time point (p = 0.046). During the randomized-withdrawal phase, the primary endpoint of time to treatment failure was statistically significant in favor of THC/CBD spray, with 57 % of patients receiving placebo failing treatment versus 24 % of patients from the THC/CBD spray group (p = 0.04). The mean change from baseline in Pain Numerical Rating Scale (NRS) (p = 0.028) and sleep quality NRS (p = 0.015) scores, both secondary endpoints in phase B, were also statistically significant compared to placebo, with estimated treatment differences of -0.79 and 0.99 points, respectively, in favor of THC/CBD spray treatment. The results of the current investigation were equivocal, with conflicting findings in the two phases of the study. We report the first phase III placebo-controlled study of the efficacy of the endocannabinoid system modulator delta-9-tetrahydrocannabinol (THC)/cannabidiol (CBD) oromucosal spray to alleviate CNP. A total of 339 patients were randomized to phase A (167 received THC/CBD spray and 172 received placebo). Of those who completed phase A, 58 entered the randomized-withdrawal phase. The primary endpoint of responder analysis at the 30 % level at week 14 of phase A of the study was not met, with 50 % of patients on THC/CBD spray classed as responders at the 30 % level compared to 45 % of patients on placebo (p = 0.234). However, an interim analysis at week 10 showed a statistically significant treatment difference in favor of THC/CBD spray at this time point (p = 0.046). During the randomized-withdrawal phase, the primary endpoint of time to treatment failure was statistically significant in favor of THC/CBD spray, with 57 % of patients receiving placebo failing treatment versus 24 % of patients from the THC/CBD spray group (p = 0.04). The mean change from baseline in Pain Numerical Rating Scale (NRS) (p = 0.028) and sleep quality NRS (p = 0.015) scores, both secondary endpoints in phase B, were also statistically significant compared to placebo, with estimated treatment differences of -0.79 and 0.99 points, respectively, in favor of THC/CBD spray treatment. The results of the current investigation were equivocal, with conflicting findings in the two phases of the study.
dcterms:title
A double-blind, randomized, placebo-controlled, parallel-group study of THC/CBD oromucosal spray in combination with the existing treatment regimen, in the relief of central neuropathic pain in patients with multiple sclerosis A double-blind, randomized, placebo-controlled, parallel-group study of THC/CBD oromucosal spray in combination with the existing treatment regimen, in the relief of central neuropathic pain in patients with multiple sclerosis
skos:prefLabel
A double-blind, randomized, placebo-controlled, parallel-group study of THC/CBD oromucosal spray in combination with the existing treatment regimen, in the relief of central neuropathic pain in patients with multiple sclerosis A double-blind, randomized, placebo-controlled, parallel-group study of THC/CBD oromucosal spray in combination with the existing treatment regimen, in the relief of central neuropathic pain in patients with multiple sclerosis
skos:notation
RIV/61989592:15110/13:33140393!RIV14-MSM-15110___
n9:predkladatel
n10:orjk%3A15110
n4:aktivita
n6:N
n4:aktivity
N
n4:cisloPeriodika
4
n4:dodaniDat
n14:2014
n4:domaciTvurceVysledku
n16:2581957
n4:druhVysledku
n5:J
n4:duvernostUdaju
n11:S
n4:entitaPredkladatele
n19:predkladatel
n4:idSjednocenehoVysledku
58593
n4:idVysledku
RIV/61989592:15110/13:33140393
n4:jazykVysledku
n18:eng
n4:klicovaSlova
multiple sclerosis; study; parallel-group; placebo-controlled; randomized; double-blind
n4:klicoveSlovo
n8:double-blind n8:placebo-controlled n8:parallel-group n8:multiple%20sclerosis n8:study n8:randomized
n4:kodStatuVydavatele
DE - Spolková republika Německo
n4:kontrolniKodProRIV
[C150577E20EE]
n4:nazevZdroje
Journal of Neurology
n4:obor
n17:FH
n4:pocetDomacichTvurcuVysledku
1
n4:pocetTvurcuVysledku
7
n4:rokUplatneniVysledku
n14:2013
n4:svazekPeriodika
260
n4:tvurceVysledku
Ratcliffe, Stuart Langford, Richard M Váchová, Marta Novotná, Alena Nováková, Iveta Mareš, Jan Notcutt, Willy
n4:wos
000317351900005
s:issn
0340-5354
s:numberOfPages
14
n12:doi
10.1007/s00415-012-6739-4
n15:organizacniJednotka
15110