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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01172405
Recruitment Status : Unknown
Verified July 2010 by Mantecorp Industria Quimica e Farmaceutica Ltd..
Recruitment status was:  Not yet recruiting
First Posted : July 29, 2010
Last Update Posted : July 29, 2010
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Headache Drug: Ibuprofen plus caffeine Drug: Ibuprofen Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : October 2010
Estimated Primary Completion Date : October 2012
Estimated Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine Headache
U.S. FDA Resources

Arms and Interventions

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 Name: DALSY

Outcome Measures

Primary Outcome Measures :
  1. Efficacy of study treatment compared with control to relieve headache symptoms. [ Time Frame: 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 :
  1. Tolerability of study treatment compared with control to relieve headache symptoms. [ Time Frame: 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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01172405

Contact: Claudia Domingues +551151885237 cdomingues@mantecorp.com

Sponsors and Collaborators
Mantecorp Industria Quimica e Farmaceutica Ltd.
More Information

Responsible Party: Celso Pereira Sustovich, Medical Director, Mantecorp Indústria Química e Farmacêutica Ltda.
ClinicalTrials.gov Identifier: NCT01172405     History of Changes
Other Study ID Numbers: IBU-CAF-01/09
First Posted: July 29, 2010    Key Record Dates
Last Update Posted: July 29, 2010
Last Verified: July 2010

Keywords provided by Mantecorp Industria Quimica e Farmaceutica Ltd.:

Additional relevant MeSH terms:
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Phosphodiesterase Inhibitors
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents