search
Back to results

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Withdrawn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
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Migraine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    August 31, 2011
    Last Updated
    November 23, 2012
    Sponsor
    Sanofi
    search

    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