Ibuprofen Versus Ibuprofen Plus Caffeine in the Treatment of Migraine.

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01426971
First received: August 31, 2011
Last updated: November 23, 2012
Last verified: November 2012
  Purpose

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 Intervention Phase
Pain
Drug: IBUPROFEN + CAFFEINE
Drug: IBUPROFEN
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Number of patients with reduction of at least 30mm in the visual scale (VAS) of pain [ Time Frame: from baseline to 60 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of patients with more than 50% of pain reduction [ Time Frame: up to 45 minutes ] [ Designated as safety issue: No ]
  • Median time of the first perception of pain relief since study medication intake [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
  • Median time to onset of significant pain relief compared to the time of study medication intake [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
  • Headache Relief Rating score (HRR) [ Time Frame: up to 60 mins ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Number of patients who used the third tablet of study medication [ Time Frame: up to 24 hours ] [ Designated as safety issue: No ]
  • Number of patients requiring rescue medication [ Time Frame: up to 24 hours ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: December 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ibuprofen+caffeine
2 capsules
Drug: IBUPROFEN + CAFFEINE
Pharmaceutical form: capsule Route of administration: oral
Active Comparator: Ibuprofen
2 capsules
Drug: IBUPROFEN
Pharmaceutical form: capsule Route of administration: oral

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01426971

Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01426971     History of Changes
Other Study ID Numbers: IBUCA_L_05619
Study First Received: August 31, 2011
Last Updated: November 23, 2012
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Sanofi:
Migraine

Additional relevant MeSH terms:
Ibuprofen
Caffeine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Central Nervous System Stimulants
Phosphodiesterase Inhibitors
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on September 30, 2014