Status:
WITHDRAWN
Non-Inferiority Comparison of Migrane® Versus Parcel ® For Treatment of Tensional Cephaleia
Lead Sponsor:
EMS
Conditions:
Tensional-type Headache
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the non-inferiority clinical efficacy of two different associations of drugs in the treatment of patients diagnosed with tensional-type headache in accordance ...
Detailed Description
* Open-label, non-inferiority, prospective, parallel group, intent to treat trial. * Experiment duration: 56 days. * 04 visits (days -7, 0, 28 and 56). * Efficacy will be evaluated for 10 episodes of ...
Eligibility Criteria
Inclusion
- Patients must be able to understand the study procedures agree to participate and give written consent.
- Tensional-type headache patients according to the International Headache Society criteria.
- Corporal body indices \< 40.
Exclusion
- Pregnancy or risk of pregnancy.
- Lactation
- Use of acetylsalicylic acid or corticosteroids or immunosuppressive therapy.
- Use of immunosuppressive drugs.
- Alterations of laboratory selective tests.
- Drugs or alcohol abuse
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01408069
Last Update
February 24 2021
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