Ibuprofen Versus Ibuprofen Plus Caffeine in the Treatment of Migraine.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01426971
Recruitment Status : Withdrawn
First Posted : September 1, 2011
Last Update Posted : November 27, 2012
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : December 2012
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine Migraine

Arm Intervention/treatment
Experimental: Ibuprofen+caffeine
2 capsules
Pharmaceutical form: capsule Route of administration: oral

Active Comparator: Ibuprofen
2 capsules
Pharmaceutical form: capsule Route of administration: oral

Primary Outcome Measures :
  1. 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 Measures :
  1. Number of patients with more than 50% of pain reduction [ Time Frame: up to 45 minutes ]
  2. Median time of the first perception of pain relief since study medication intake [ Time Frame: 4 hours ]
  3. Median time to onset of significant pain relief compared to the time of study medication intake [ Time Frame: 4 hours ]
  4. Headache Relief Rating score (HRR) [ Time Frame: up to 60 mins ]
  5. 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 ]
  6. Number of patients who used the third tablet of study medication [ Time Frame: up to 24 hours ]
  7. Number of patients requiring rescue medication [ Time Frame: up to 24 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01426971

Sponsors and Collaborators
Study Director: Clinical Sciences & Operations Sanofi

Responsible Party: Sanofi Identifier: NCT01426971     History of Changes
Other Study ID Numbers: IBUCA_L_05619
First Posted: September 1, 2011    Key Record Dates
Last Update Posted: November 27, 2012
Last Verified: November 2012

Keywords provided by Sanofi:

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Phosphodiesterase Inhibitors
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents