Ibuprofen Versus Ibuprofen Plus Caffeine in the Treatment of Migraine.
Primary Purpose
Pain
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
IBUPROFEN + CAFFEINE
IBUPROFEN
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring Migraine
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ibuprofen+caffeine
Ibuprofen
Arm Description
2 capsules
2 capsules
Outcomes
Primary Outcome Measures
Number of patients with reduction of at least 30mm in the visual scale (VAS) of pain
Secondary Outcome Measures
Number of patients with more than 50% of pain reduction
Median time of the first perception of pain relief since study medication intake
Median time to onset of significant pain relief compared to the time of study medication intake
Headache Relief Rating score (HRR)
Mean of VAS difference between each time after medication intake and the baseline.
Number of patients who used the third tablet of study medication
Number of patients requiring rescue medication
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01426971
Brief Title
Ibuprofen Versus Ibuprofen Plus Caffeine in the Treatment of Migraine.
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Withdrawn
Study Start Date
December 2012 (undefined)
Primary Completion Date
June 2013 (Anticipated)
Study Completion Date
June 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
4. Oversight
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
Migraine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ibuprofen+caffeine
Arm Type
Experimental
Arm Description
2 capsules
Arm Title
Ibuprofen
Arm Type
Active Comparator
Arm Description
2 capsules
Intervention Type
Drug
Intervention Name(s)
IBUPROFEN + CAFFEINE
Intervention Description
Pharmaceutical form: capsule Route of administration: oral
Intervention Type
Drug
Intervention Name(s)
IBUPROFEN
Intervention Description
Pharmaceutical form: capsule Route of administration: oral
Primary Outcome Measure Information:
Title
Number of patients with reduction of at least 30mm in the visual scale (VAS) of pain
Time Frame
from baseline to 60 minutes
Secondary Outcome Measure Information:
Title
Number of patients with more than 50% of pain reduction
Time Frame
up to 45 minutes
Title
Median time of the first perception of pain relief since study medication intake
Time Frame
4 hours
Title
Median time to onset of significant pain relief compared to the time of study medication intake
Time Frame
4 hours
Title
Headache Relief Rating score (HRR)
Time Frame
up to 60 mins
Title
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
Title
Number of patients who used the third tablet of study medication
Time Frame
up to 24 hours
Title
Number of patients requiring rescue medication
Time Frame
up to 24 hours
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:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Ibuprofen Versus Ibuprofen Plus Caffeine in the Treatment of Migraine.
We'll reach out to this number within 24 hrs