Back to resultsEfficacy and Safety Study to Compare Ibuprofen + Caffeine With Ibuprofen Alone in the Treatment of Headache
Primary Purpose
Headache
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Ibuprofen plus caffeine
Ibuprofen
Sponsored by
About this trial
This is an interventional treatment trial for Headache focused on measuring Headache, Migraine, Ibuprofen, Caffeine
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ibuprofen + Caffeine
Ibuprofen
Arm Description
72 patients treated with one or two tablets of ibuprofen 400 mg + caffeine 200 mg when presenting headache.
72 patients treated with one or two tablets of ibuprofen 400 mg when presenting headache.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01172405
First Posted
July 28, 2010
Last Updated
July 28, 2010
Sponsor
Mantecorp Industria Quimica e Farmaceutica Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01172405
Brief Title
Efficacy and Safety Study to Compare Ibuprofen + Caffeine With Ibuprofen Alone in the Treatment of Headache
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 Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
October 2012 (Anticipated)
Study Completion Date
October 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Mantecorp Industria Quimica e Farmaceutica Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache
Keywords
Headache, Migraine, Ibuprofen, Caffeine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
144 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ibuprofen + Caffeine
Arm Type
Experimental
Arm Description
72 patients treated with one or two tablets of ibuprofen 400 mg + caffeine 200 mg when presenting headache.
Arm Title
Ibuprofen
Arm Type
Active Comparator
Arm Description
72 patients treated with one or two tablets of ibuprofen 400 mg when presenting headache.
Intervention Type
Drug
Intervention Name(s)
Ibuprofen plus caffeine
Intervention Description
One or two tablets of ibuprofen 400 mg + caffeine 200 mg when presenting headache.
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Other Intervention Name(s)
DALSY
Intervention Description
One or two tablets of ibuprofen 400 mg when presenting headache.
Primary Outcome Measure Information:
Title
Efficacy of study treatment compared with control to relieve headache symptoms.
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Tolerability of study treatment compared with control to relieve headache symptoms.
Description
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.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Claudia Domingues
Phone
+551151885237
Email
cdomingues@mantecorp.com
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety Study to Compare Ibuprofen + Caffeine With Ibuprofen Alone in the Treatment of Headache
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