Status:
WITHDRAWN
Ibuprofen Versus Ibuprofen Plus Caffeine in the Treatment of Migraine.
Lead Sponsor:
Sanofi
Conditions:
Pain
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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 baseli...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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
- Exclusion criteria:
- 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
- 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.
Exclusion
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01426971
Start Date
December 1 2012
End Date
June 1 2013
Last Update
November 27 2012
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