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Cefalium® Compared to Tylenol® in the Treatment of Migraine Attacks

NCT02582996 · Status: SUSPENDED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 336

Last updated 2019-04-10

No results posted yet for this study

Summary

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®.

Conditions

Interventions

DRUG

Acetaminophen+Caffeine+Dihydroergotamine+Metoclopramide.

The subject must manage 02 tablets of Cefalium right after a moderate to severe migraine.

DRUG

Acetaminophen

The subject must manage 02 tablets of Tylenol right after a moderate to severe migraine.

Sponsors & Collaborators

  • Ache Laboratorios Farmaceuticos S.A.

    lead INDUSTRY

Principal Investigators

  • Thais Villa · Federal University of São Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-30
Primary Completion
2021-04-30
Completion
2021-06-30

Countries

  • Brazil

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02582996 on ClinicalTrials.gov