Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2025-12-25 @ 3:10 AM
NCT ID:
NCT01172405
Eligibility Criteria:
Inclusion Criteria:
* Patients with ability to read, understand and sign the IC;
* Patients with symptoms of frequent episodic tension headache, mild to moderate;
* Patients with symptoms of migraine with or without aura, of mild to moderate intensity;
* Patients who have had between two and five headache attacks in the last 30 days;
* Patients who accept the condition of ingesting less than three cups of coffee per day and / or reduce the intake of any beverage that contains caffeine;
* Patients who accept the condition not to drink any beverage that contains caffeine for 24 hours after drug administration.
* Patients able to understand and maintain the clinical protocol.
* Patients who started or changed prophylactic treatment for headache 30 days before inclusion.
* Female patients of childbearing age must agree to undergo pregnancy testing through urine.
Exclusion Criteria:
* Patients in whom headache began after 50 years of age;
* Patients with strong or disabling headaches;
* Patients with chronic daily headaches lasting up to 72 h or with cluster headaches not responsive to common analgesics;
* Patients with headaches occurring in 15 or more days per month;
* Patients with secondary headaches;
* Patients who overuse analgesics (acetylsalicylic acid up to 300 mg / day) or NSAIDs;
* Known hypersensitivity to components of both formulations of the drug test as the comparison;
* Known hepatic or renal diseases;
* Patients who are pregnant or intend to become pregnant or lactating;
* Patients with severe concomitant systemic diseases such as cancer, diabetes, congenital or acquired heart diseases, hematological diseases, convulsive disorders, autoimmune diseases, renal failure, severe infections, hormonal disorders, pulmonary disorders and peptic diseases;
* History of alcoholism or substance abuse.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01172405
Study Brief:
Protocol Section:
NCT01172405