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Efficacy and Safety Study to Compare Ibuprofen + Caffeine With Ibuprofen Alone in the Treatment of Headache

Information source: Mantecorp Industria Quimica e Farmaceutica Ltd.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Headache

Intervention: Ibuprofen plus caffeine (Drug); Ibuprofen (Drug)

Phase: Phase 3

Status: Not yet recruiting

Sponsored by: Mantecorp Industria Quimica e Farmaceutica Ltd.

Overall contact:
Claudia Domingues, Phone: +551151885237, Email: cdomingues@mantecorp.com


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.

Clinical Details

Official title: A Clinical Multicenter, Phase III, Randomized, Double-blind, Prospective and Comparative Trial to Evaluate the Efficacy and Safety of the Combination of Ibuprofen + Caffeine in the Treatment of Headache Attacks, Compared to Ibuprofen Alone.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

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.


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


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


- 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


- 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


- 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.

Locations and Contacts

Claudia Domingues, Phone: +551151885237, Email: cdomingues@mantecorp.com

Additional Information

Starting date: October 2010
Last updated: July 28, 2010

Page last updated: August 23, 2015

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