HeadachePhase 3NCT01172405
Efficacy and Safety Study to Compare Ibuprofen + Caffeine With Ibuprofen Alone in the Treatment of Headache
A Phase 3 study testing Ibuprofen plus caffeine and Ibuprofen in people with Headache, run by Mantecorp Industria Quimica e Farmaceutica Ltd..
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Headache
- What is being tested?
- Ibuprofen plus caffeine and Ibuprofen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- No sites listed yet
- Study dates
- Oct 2010to Oct 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibuprofen plus caffeineDrug
One or two tablets of ibuprofen 400 mg + caffeine 200 mg when presenting headache.
IbuprofenDrug
Also called DALSY
One or two tablets of ibuprofen 400 mg when presenting headache.
| Study group | Role | What they receive |
|---|---|---|
| Ibuprofen + Caffeine | Experimental | 72 patients treated with one or two tablets of ibuprofen 400 mg + caffeine 200 mg when presenting headache. Receives: Drug: Ibuprofen plus caffeine |
| Ibuprofen | Active comparator | 72 patients treated with one or two tablets of ibuprofen 400 mg when presenting headache. Receives: Drug: Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (1)
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2010 (estimated)
- Study startOct 2010
- Primary completionOct 2012 (estimated)
- Study completionOct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mantecorp Industria Quimica e Farmaceutica Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01172405
- Sponsor's protocol ID
- IBU-CAF-01/09
- Status last verified
- Jul 2010
- First submitted
- 28 Jul 2010
- Last updated
- 29 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01172405
- Acronym / sponsor ID
- IBU-CAF-01/09
- Conditions
- Headache
- Keywords
- Headache, Migraine, Ibuprofen, Caffeine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Mantecorp Industria Quimica e Farmaceutica Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 29 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ibuprofen + Caffeine | Experimental | Drug: Ibuprofen plus caffeine72 patients treated with one or two tablets of ibuprofen 400 mg + caffeine 200 mg when presenting headache. |
| Ibuprofen | Active comparator | Drug: Ibuprofen72 patients treated with one or two tablets of ibuprofen 400 mg when presenting headache. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ibuprofen plus caffeineOne or two tablets of ibuprofen 400 mg + caffeine 200 mg when presenting headache. | Drug | Ibuprofen + Caffeine |
| IbuprofenAlso: DALSYOne or two tablets of ibuprofen 400 mg when presenting headache. | Drug | Ibuprofen |
Primary outcome
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.
1 secondary outcome
Tolerability of study treatment compared with control to relieve headache symptoms.
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ibuprofen plus caffeine and Ibuprofen in people with Headache, run by Mantecorp Industria Quimica e Farmaceutica Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claudia Domingues (+551151885237, cdomingues@mantecorp.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of study treatment compared with control to relieve headache symptoms. (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2010.