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National, Phase III, Multicenter, Randomized, Open, Parallel, to Evaluate the Efficacy, Safety and Superiority of Cefalium® Compared to the Tylenol® in the Treatment of Migraine Attacks
National clinical trials, phase III, randomized, open, parallel, study of superiority, in which three hundred thirty-six (336) participants of both sexes, aged between 18 and 65 years will be randomly allocated to one of two treatment groups. The Group 01 will use Cefalium® and group 02 will use Tylenol®.
Cefalium® is a combination of Caffeine + Paracetamol + dihydroergotamine mesylate + metoclopramide hydrochloride. The dihydroergotamine mesylate interacts with the serotonergic, dopaminergic and noradrenergic receptors, but it's mechanism is not totally known. The caffeine presents mechanisms that are not totally clear, but it may relieves the pain by activating of the central noradenosine pathway (pain suppressing system). The Metoclopramide hydrochloride presents an anti-emetic action and prokinetic action in the gastrointestinal tract.One of its properties is the inhibition of nausea and vomiting triggered by drugs such as ergotamine.Paracetamol, also called acetaminophen is an effective agent analgesic and antipyretic with weak anti-inflammatory activity.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
Centro de Pesquisa Clínica - CPEC / Associação Obras Sociais Irmã Dulce
Salvador, Estado de Bahia, Brazil
Centro de Pesquisa Clínica Hospital São Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, Brazil
Centro de Desenvolvimento em Estudos Clínicos Brasil - CDEC Brasil
São Paulo, Brazil
Cepic - Centro Paulista de Investigação Clínica
São Paulo, Brazil
CPCLIN - Centro de Pesquisas Clinicas Ltda
São Paulo, Brazil
Universidade Federal de São Paulo - Núcleo de Gestão de Pesquisa/HU/FAP
São Paulo, Brazil
Start Date
April 1, 2020
Primary Completion Date
April 1, 2021
Completion Date
June 1, 2021
Last Updated
April 10, 2019
336
ESTIMATED participants
Acetaminophen+Caffeine+Dihydroergotamine+Metoclopramide.
DRUG
Acetaminophen
DRUG
Lead Sponsor
Ache Laboratorios Farmaceuticos S.A.
NCT07018713
NCT06641466
NCT04715685
Data Source & Attribution
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