Efficacy and Safety of Rizatriptan-Naproxen (10/550 Mg) in the Acute Treatment of Migraine
NCT ID: NCT04384367
Last Updated: 2025-02-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
2068 participants
INTERVENTIONAL
2022-12-30
2024-11-30
Brief Summary
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⚠️Study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).
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Detailed Description
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⚠️Study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Rizatriptan 10mg+ Naproxen 550mg
Rizatriptan 10mg+ Naproxen 550mg
Rizatriptan 10 mg + Naproxen 550mg
oral - single dose
Maxalt 10mg
Rizatriptan10mg
Maxalt 10Mg Tablet
oral - single dose
Flanax 550mg
Naproxen 550mg
Flanax 550mg
oral - single dose
Placebo
Placebo
Placebo oral tablet
oral - single dose
Interventions
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Rizatriptan 10 mg + Naproxen 550mg
oral - single dose
Maxalt 10Mg Tablet
oral - single dose
Flanax 550mg
oral - single dose
Placebo oral tablet
oral - single dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Aged between 18 and 65 years old;
* Capable and willing to give free and informed informed consent in writing;
* Migraine patients with or without aura, according to the International Headache Society (IHS).
Exclusion Criteria
* Headache other than migraine (that is, tension-type headache, sinusitis, etc.).
18 Years
65 Years
ALL
No
Sponsors
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Eurofarma Laboratorios S.A.
INDUSTRY
Responsible Party
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Locations
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Eurofarma Laboratorios S.A
São Paulo, São Paulo, Brazil
CEPIC
São Paulo, São Paulo, Brazil
Countries
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Other Identifiers
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EF167
Identifier Type: -
Identifier Source: org_study_id
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