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

Phase 3

• Conditions: Headache
• Interventions: Drug: Ibuprofen plus caffeine; Drug: Ibuprofen

• Registration Number: NCT01172405
• Lead Sponsor: Mantecorp Industria Quimica e Farmaceutica Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-07
• Study First Submitted: 2010-07-28
• Study First Submitted QC: 2010-07-28
• Last Update Submitted: 2010-07-28
• Study First Posted: 2010-07-29
• Last Update Posted: 2010-07-29
• Study Start: 2010-10
• Primary Completion: 2012-10
• Study Completion: 2012-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 144

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ibuprofen + Caffeine	Ibuprofen plus caffeine	72 patients treated with one or two tablets of ibuprofen 400 mg + caffeine 200 mg when presenting headache.
Ibuprofen	Ibuprofen	72 patients treated with one or two tablets of ibuprofen 400 mg when presenting headache.

Primary Outcome Measures

Name	Time	Method
Efficacy of study treatment compared with control to relieve headache symptoms.	4 weeks	The evaluation of efficacy will be determined based on comparison of the intensity of headache before and after initiation of treatment, using the Functional Disabling Scale. The opinion of the investigator will be established based on the Likert scale and duration of symptoms after the treatment will be checked as a measure of comparison between treatments in the study.

Secondary Outcome Measures

Name	Time	Method
Tolerability of study treatment compared with control to relieve headache symptoms.	4 weeks	Tolerability will be assessed by the investigator through the number of adverse events definitely related to study medication. This relationship will be defined by applying the Naranjo algorithm.