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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Mantecorp Industria Quimica e Farmaceutica Ltd..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Mantecorp Industria Quimica e Farmaceutica Ltd.
ClinicalTrials.gov Identifier:
NCT01172405
First received: July 28, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted
  Purpose

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 Intervention Phase
Headache
Drug: Ibuprofen plus caffeine
Drug: Ibuprofen
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


Further study details as provided by Mantecorp Industria Quimica e Farmaceutica Ltd.:

Primary Outcome Measures:
  • Efficacy of study treatment compared with control to relieve headache symptoms. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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:
  • Tolerability of study treatment compared with control to relieve headache symptoms. [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 144
Study Start Date: October 2010
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01172405

Contacts
Contact: Claudia Domingues +551151885237 cdomingues@mantecorp.com

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

No publications provided

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
Study First Received: July 28, 2010
Last Updated: July 28, 2010
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Mantecorp Industria Quimica e Farmaceutica Ltd.:
Headache
Migraine
Ibuprofen
Caffeine

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

ClinicalTrials.gov processed this record on November 20, 2014