Headache | Efficacy and Safety Study to Compare Ibuprofen + Caffeine With Ibuprofen Alone in the Treatment of Headache
Headache research study
What is the primary objective of this study?
Based on established therapeutic effect of ibuprofen in the treatment of headache attacks, and the action of caffeine in promoting better results when combined with treatments of first choice in the treatment of headache, this study is designed to: - evaluate the efficacy of therapy with ibuprofen + caffeine in headache patients compared to ibuprofen alone; - evaluate the tolerability of the association ibuprofen + caffeine compared to ibuprofen alone. The hypothesis is that the association is superior to treatment with ibuprofen alone in terms of efficacy, while maintaining good tolerability.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Ibuprofen plus caffeineOne or two tablets of ibuprofen 400 mg + caffeine 200 mg when presenting headache.
Drug:IbuprofenOne or two tablets of ibuprofen 400 mg when presenting headache.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Ibuprofen + Caffeine72 patients treated with one or two tablets of ibuprofen 400 mg + caffeine 200 mg when presenting headache.
Ibuprofen72 patients treated with one or two tablets of ibuprofen 400 mg when presenting headache.
Start Date: October 2010
Completed Date: October 2012
Phase: Phase 3
Primary Outcome: Efficacy of study treatment compared with control to relieve headache symptoms.
Secondary Outcome: Tolerability of study treatment compared with control to relieve headache symptoms.
Study sponsors, principal investigator, and references
Lead Sponsor: Mantecorp Industria Quimica e Farmaceutica Ltd.