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
Recruitment status was Not yet recruiting
Sponsor:
Mantecorp Industria Quimica e Farmaceutica Ltd.
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
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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
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 Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Caffeine Ibuprofen Central Nervous System Stimulants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Phosphodiesterase Inhibitors Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Purinergic P1 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors |
ClinicalTrials.gov processed this record on May 21, 2013