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

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.

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.

Study Overview

• Status: Unknown
• Conditions: Headache
• Intervention / Treatment: Drug: Ibuprofen plus caffeine; Drug: Ibuprofen

• Study Type: Interventional
• Enrollment (Anticipated): 144
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ibuprofen + Caffeine; 72 patients treated with one or two tablets of ibuprofen 400 mg + caffeine 200 mg when presenting headache.	Drug: Ibuprofen plus caffeine; One or two tablets of ibuprofen 400 mg + caffeine 200 mg when presenting headache.
Active Comparator: Ibuprofen; 72 patients treated with one or two tablets of ibuprofen 400 mg when presenting headache.	Drug: Ibuprofen; One or two tablets of ibuprofen 400 mg when presenting headache.; Other Names: DALSY

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of study treatment compared with control to relieve headache symptoms.	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.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerability of study treatment compared with control to relieve headache symptoms.	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.	4 weeks

Collaborators and Investigators

• Sponsor: Mantecorp Industria Quimica e Farmaceutica Ltd.

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Anticipated): October 1, 2012
• Study Completion (Anticipated): October 1, 2012

Study Registration Dates

• First Submitted: July 28, 2010
• First Submitted That Met QC Criteria: July 28, 2010
• First Posted (Estimate): July 29, 2010

Study Record Updates

• Last Update Posted (Estimate): July 29, 2010
• Last Update Submitted That Met QC Criteria: July 28, 2010
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Keywords: Migraine; Headache; Ibuprofen; Caffeine
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Headache; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Purinergic Antagonists; Purinergic Agents; Phosphodiesterase Inhibitors; Purinergic P1 Receptor Antagonists; Central Nervous System Stimulants; Ibuprofen; Caffeine
• Other Study ID Numbers: IBU-CAF-01/09