PainPhase 3NCT01426971
Ibuprofen Versus Ibuprofen Plus Caffeine in the Treatment of Migraine.
A Phase 3 study testing IBUPROFEN + CAFFEINE and IBUPROFEN in people with Pain, run by Sanofi.
Trial summary
Primary Objective: To compare the treatment groups in the reduction of pain score by at least 30 mm on a visual pain scale (VAS) at 60 minutes after study medication intake, compared to the baseline score (obtained before the study medication intake). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain
- What is being tested?
- IBUPROFEN + CAFFEINE and IBUPROFEN
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2012to Jun 2013
- 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
- 18 years old to less ore equal than 65 with migraine defined according to the criteria of the headache Classification Committee (ICHD II) of the International Headache Society (HIS)
- Migraine first onset before 50 years old
- Occurrence of at least one episode every two months or up to 8 episodes per month during the previous 3 months, which must not exceed 14 days per month
- Pain relief with the use of Over The Counter (OTC) medicines by at least 75% of episodes
- Headache of at least moderate intensity (VAS greater than 30 mm), at least 75% of episodes
- Absence of caffeine and black tea at least 2 hours before and one hour after drug administration
Who cannot join
- Use of acupuncture, homeopathy and/or phytotherapy
- Use of Tryptanes in the last 30 hours, no steroidal anti-inflammatory drugs in the last 48 hours and analgesics in the last 15 hours
- Use of analgesics drug products for more than 10 days per month, consecutive or not, for a period exceeding three months
- Other types of headache that is not migraine, according to the International Classification of Headache Disorders (ICHD II)
- Chronic and complicated migraine, according to ICHD II
- Coexisting disease or significant medical conditions which in the investigators judgment interfere and/or prevent the individuals proper participation in the study
Show all 19Show fewer
- Treatment with methotrexate, glucocorticoids, anticoagulants and/or lithium
- Hypersensibility to study medication (or any component of the formula), to acetyl salicylic, no steroidal anti-inflammatory drugs and/or any other analgesic or antipyretic
- Nasal polyps, asthma and / or other allergic manifestations
- Subjects with edema, diarrhea and/or vomiting, who are not eating or drinking fluids properly according to the investigators judgment or experiencing visual disorders
- Use of antihypertensive medications and/or psychoactive in the last 6 months
- History of anorexia, bulimia and/or mental disorders
- History of tachycardia, arrhythmia, congestive heart failure, coronary artery disease and/or coagulopathy
- History of thyroid disease and/or parathyroid disease, liver disease and/or gastrointestinal
- History of dyspeptic disorder, including gastritis, peptic ulcer and/or gastrointestinal bleeding
- Impaired renal function tests and/or history of renal disease, including kidney failure
- Pregnant (or planning to become pregnant during the course of the study) or who are breast feeding
- Woman in childbearing age, childbearing potential not protected by an effective contraceptive method of birth control. Status of pregnancy should be checked for pregnancy test serum or urine before exposure to the Investigational product.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
About this study
Official title: National, Controlled, Randomized, Double-blind, Parallel Study to Investigate the Efficacy of 2 Capsules of Ibuprofen 400mg in Association With Caffeine 100mg in Fixed Dose Combination Compared to Two Capsules of Ibuprofen 400mg in the Treatment of Migraine
Primary Objective:
- To compare the treatment groups in the reduction of pain score by at least 30 mm on a visual pain scale (VAS) at 60 minutes after study medication intake, compared to the baseline score (obtained before the study medication intake).
Read more
Secondary Objectives:
- To assess the proportion of patients with more than 50% pain relief, according to the VAS score at 45 minutes after study medication intake compared to baseline
- Determine the following aspects in the timing of study medication intake:
- Time to the first perception of pain relief
- Time to onset of meaningful pain relief
- Reduction of pain at 15, 30, 45, 60, 120 and 240 minutes after study medication intake, to be evaluated as the difference between the scores on VAS in each period and baseline
- To assess the pain according to the five items of Headache Relief Rating - HRR (0: strong worsening 1: slight worsening 2: no change 3: slight improvement 4: strong improvement) at 15, 30, 45 and 60 minutes after study medication intake, according to the diaries completed by the patients
- To check the proportion of the patients requiring the third tablet of study medication within 24 hours of starting the study treatment and when it occurred
- To check the timing and frequency of rescue medication intake, as well as the proportion of patients who used these medications within 24 hours of starting the treatment
- Safety assessment.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBUPROFEN + CAFFEINEDrug
Pharmaceutical form: capsule Route of administration: oral
IBUPROFENDrug
Pharmaceutical form: capsule Route of administration: oral
| Study group | Role | What they receive |
|---|---|---|
| Ibuprofen+caffeine | Experimental | 2 capsules Receives: Drug: IBUPROFEN + CAFFEINE |
| Ibuprofen | Active comparator | 2 capsules Receives: Drug: IBUPROFEN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with reduction of at least 30mm in the visual scale (VAS) of pain
Measured: from baseline to 60 minutes
Secondary outcomes (7)
Number of patients with more than 50% of pain reduction
Measured: up to 45 minutes
Median time of the first perception of pain relief since study medication intake
Measured: 4 hours
Median time to onset of significant pain relief compared to the time of study medication intake
Measured: 4 hours
Headache Relief Rating score (HRR)
Measured: up to 60 mins
Mean of VAS difference between each time after medication intake and the baseline.
Measured: 15, 30, 45, 60, 120 and 240 minutes post dose
Number of patients who used the third tablet of study medication
Measured: up to 24 hours
Number of patients requiring rescue medication
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2011 (estimated)
- Study startDec 2012
- Primary completionJun 2013 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- 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
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01426971
- Sponsor's protocol ID
- IBUCA_L_05619
- Status last verified
- Nov 2012
- First submitted
- 31 Aug 2011
- Last updated
- 27 Nov 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National, Controlled, Randomized, Double-blind, Parallel Study to Investigate the Efficacy of 2 Capsules of Ibuprofen 400mg in Association With Caffeine 100mg in Fixed Dose Combination Compared to Two Capsules of Ibuprofen 400mg in the Treatment of Migraine
- ClinicalTrials.gov ID
- NCT01426971
- Acronym / sponsor ID
- IBUCA_L_05619
- Conditions
- Pain
- Keywords
- Migraine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 1 Sep 2011 (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.
Primary Objective:
- To compare the treatment groups in the reduction of pain score by at least 30 mm on a visual pain scale (VAS) at 60 minutes after study medication intake, compared to the baseline score (obtained before the study medication intake).
Secondary Objectives:
- To assess the proportion of patients with more than 50% pain relief, according to the VAS score at 45 minutes after study medication intake compared to baseline
- Determine the following aspects in the timing of study medication intake:
- Time to the first perception of pain relief
- Time to onset of meaningful pain relief
- Reduction of pain at 15, 30, 45, 60, 120 and 240 minutes after study medication intake, to be evaluated as the difference between the scores on VAS in each period and baseline
- To assess the pain according to the five items of Headache Relief Rating - HRR (0: strong worsening 1: slight worsening 2: no change 3: slight improvement 4: strong improvement) at 15, 30, 45 and 60 minutes after study medication intake, according to the diaries completed by the patients
- To check the proportion of the patients requiring the third tablet of study medication within 24 hours of starting the study treatment and when it occurred
- To check the timing and frequency of rescue medication intake, as well as the proportion of patients who used these medications within 24 hours of starting the treatment
- Safety assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ibuprofen+caffeine | Experimental | Drug: IBUPROFEN + CAFFEINE2 capsules |
| Ibuprofen | Active comparator | Drug: IBUPROFEN2 capsules |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years old to less ore equal than 65 with migraine defined according to the criteria of the headache Classification Committee (ICHD II) of the International Headache Society (HIS)
- Migraine first onset before 50 years old
- Occurrence of at least one episode every two months or up to 8 episodes per month during the previous 3 months, which must not exceed 14 days per month
- Pain relief with the use of Over The Counter (OTC) medicines by at least 75% of episodes
- Headache of at least moderate intensity (VAS greater than 30 mm), at least 75% of episodes
Key exclusion criteria (19 listed)
- Use of acupuncture, homeopathy and/or phytotherapy
- Use of Tryptanes in the last 30 hours, no steroidal anti-inflammatory drugs in the last 48 hours and analgesics in the last 15 hours
- Use of analgesics drug products for more than 10 days per month, consecutive or not, for a period exceeding three months
- Other types of headache that is not migraine, according to the International Classification of Headache Disorders (ICHD II)
- Chronic and complicated migraine, according to ICHD II
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 + CAFFEINEPharmaceutical form: capsule Route of administration: oral | Drug | Ibuprofen+caffeine |
| IBUPROFENPharmaceutical form: capsule Route of administration: oral | Drug | Ibuprofen |
Primary outcome
Number of patients with reduction of at least 30mm in the visual scale (VAS) of pain
Time frame: from baseline to 60 minutes
7 secondary outcomes
Number of patients with more than 50% of pain reduction
Time frame: up to 45 minutes
Median time of the first perception of pain relief since study medication intake
Time frame: 4 hours
Median time to onset of significant pain relief compared to the time of study medication intake
Time frame: 4 hours
Headache Relief Rating score (HRR)
Time frame: up to 60 mins
Mean of VAS difference between each time after medication intake and the baseline.
Time frame: 15, 30, 45, 60, 120 and 240 minutes post dose
Number of patients who used the third tablet of study medication
Time frame: up to 24 hours
Number of patients requiring rescue medication
Time frame: up to 24 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2012.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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.
Clinical Sciences & Operations study director
Sanofi
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IBUPROFEN + CAFFEINE and IBUPROFEN in people with Pain, run by Sanofi.
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 6 inclusion and 19 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: withdrawn, as of the sponsor's last update on 27 Nov 2012. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with reduction of at least 30mm in the visual scale (VAS) of pain (time frame: from baseline to 60 minutes). 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 27 Nov 2012.