Efficacy and Safety of a Fixed-dose Combination of Naratriptan and Naproxen in Acute Treatment of Migraine.
NCT01726920 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL
Last updated 2016-03-16
Summary
The purpose of this study is to determine whether a fixed-dose combination of naratriptan 2,5 mg + naproxen 500 mg is effective and safe compared each monotherapy for the acute treatment of migraine.
Conditions
Interventions
- DRUG
-
naratriptan + naproxen
Tablets containing naratriptan 2,5 mg + naproxen 500 mg
- DRUG
-
naratriptan
Tablets containing naratriptan 2,5 mg
- DRUG
-
naproxen
Tablets containing naproxen 500 mg
Sponsors & Collaborators
-
Ache Laboratorios Farmaceuticos S.A.
lead INDUSTRY
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
- 2014-07-31
- Primary Completion
- 2014-12-31
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