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

July 28, 2010
July 28, 2010
October 2010
October 2012   (final data collection date for primary outcome measure)
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.
Same as current
No Changes Posted
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.
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Headache
  • Drug: Ibuprofen plus caffeine
    One or two tablets of ibuprofen 400 mg + caffeine 200 mg when presenting headache.
  • Drug: Ibuprofen
    One or two tablets of ibuprofen 400 mg when presenting headache.
    Other Name: DALSY
  • Experimental: Ibuprofen + Caffeine
    72 patients treated with one or two tablets of ibuprofen 400 mg + caffeine 200 mg when presenting headache.
    Intervention: Drug: Ibuprofen plus caffeine
  • Active Comparator: Ibuprofen
    72 patients treated with one or two tablets of ibuprofen 400 mg when presenting headache.
    Intervention: Drug: Ibuprofen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
144
October 2012
October 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact: Claudia Domingues +551151885237 cdomingues@mantecorp.com
Not Provided
 
NCT01172405
IBU-CAF-01/09
Yes
Celso Pereira Sustovich, Medical Director, Mantecorp Indústria Química e Farmacêutica Ltda.
Mantecorp Industria Quimica e Farmaceutica Ltd.
Not Provided
Not Provided
Mantecorp Industria Quimica e Farmaceutica Ltd.
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP