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

NCT ID: NCT01172405

Last Updated: 2010-07-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2012-10-31

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.

Conditions

Headache

Keywords

Headache; Migraine; Ibuprofen; Caffeine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Ibuprofen + Caffeine

72 patients treated with one or two tablets of ibuprofen 400 mg + caffeine 200 mg when presenting headache.

Group Type: EXPERIMENTAL

Ibuprofen plus caffeine

Intervention Type: DRUG

One or two tablets of ibuprofen 400 mg + caffeine 200 mg when presenting headache.

Ibuprofen

72 patients treated with one or two tablets of ibuprofen 400 mg when presenting headache.

Group Type: ACTIVE_COMPARATOR

Ibuprofen

Intervention Type: DRUG

One or two tablets of ibuprofen 400 mg when presenting headache.

Interventions

Ibuprofen plus caffeine

One or two tablets of ibuprofen 400 mg + caffeine 200 mg when presenting headache.

Intervention Type: DRUG

Ibuprofen

One or two tablets of ibuprofen 400 mg when presenting headache.

Intervention Type: DRUG

Other Intervention Names

DALSY

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mantecorp Industria Quimica e Farmaceutica Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Mantecorp Indústria Química e Farmacêutica Ltda.

Central Contacts

Claudia Domingues

Role: CONTACT

Phone: +551151885237

Email: cdomingues@mantecorp.com

Other Identifiers

IBU-CAF-01/09

Identifier Type: -

Identifier Source: org_study_id