We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Double-blind, Placebo-controlled Pilot Study to Collect and Evaluate Data on the Use of Intravenous Ibuprofen in the Treatment of an Acute Migraine Attack

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01230411
Recruitment Status : Recruiting
First Posted : October 29, 2010
Last Update Posted : June 14, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

This is a pilot trial to collect data on the use of intravenous ibuprofen (IVIb) in the treatment of an acute migraine attack. Data will be collected on the efficacy of IVIb in subjects who are treated with study medication between 2 and 72 hours from time of onset of headache.

Periodic safety and efficacy assessments will be performed prior to and after study drug administration.

Null hypothesis: There is no difference in the proportion of subjects in the 2 treatment groups (active treatment and placebo) who have pain relief at 2 hours after the completion of the double-blind treatment infusion. Pain relief is defined as a reduction in headache pain level from severe or moderate decreased to mild or headache-free, respectively.


Condition or disease Intervention/treatment Phase
Episodic Migraine Other: saline placebo Drug: Ibuprofen Phase 4

Detailed Description:

This is a pilot trial to collect and evaluate data on the use of intravenous ibuprofen (IVIb) in the treatment of an acute migraine attack. Data will be collected on the efficacy of IVIb in subjects who are treated with study medication between 2 and 72 hours from time of onset of headache.

Periodic safety and efficacy assessments will be performed prior to and after study drug administration.

Null hypothesis: There is no difference in the proportion of subjects in the 2 treatment groups (active treatment and placebo) who have pain relief at 2 hours after the completion of the double-blind treatment infusion. Pain relief is defined as a reduction in headache pain level from severe or moderate decreased to mild or headache-free, respectively.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-controlled Pilot Study to Collect and Evaluate Data on the Use of Intravenous Ibuprofen in the Treatment of an Acute Migraine Attack
Study Start Date : June 2011
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: placebo
IV saline administration as placebo
Other: saline placebo
250 cc of placebo administered IV
Experimental: Ibuprofen
IV ibuprofen
Drug: Ibuprofen
800 mg ibuprofen in 250 cc saline administered IV
Other Name: Caldolor


Outcome Measures

Primary Outcome Measures :
  1. Comparison of proportion of subjects in control and active treatment groups who have pain relief at 2 hours after the completion of the double-blind treatment infusion. [ Time Frame: 24 hours ]
    Comparison of proportion of subjects in each treatment group (active treatment and placebo) who have pain relief at 2 hours after the completion of the double-blind treatment infusion. Pain relief is defined as a reduction in headache pain level from severe or moderate decreased to mild or headache-free, respectively.


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Male and female subjects between the ages of 18 and 65, inclusive
  • Subject diagnosed with episodic migraine, with or without aura according to ICHD-2 criteria for at least one-year prior to screening
  • Subject experiences between 2-10 migraine attacks per month (during the previous 6 months) with no more than 15 days of headache per month.
  • Subject is using or agrees to use for the duration of participation a medically acceptable form of contraception (as determined by investigator), if female and of child-bearing potential
  • Subject is able to come for 4 hour in-clinic treatment of an acute migraine attack
  • Subjects are able to understand and comply with all study procedures.
  • Subject provides written informed consent prior to any screening procedures being conducted
  • If subject is on an allowable migraine preventive medication, the dose has been stable for at least 4 weeks prior to screening and the dose will remain stable throughout study participation.

Exclusion Criteria:

  • Unable to make a reliable self-report of pain intensity to pain relief
  • Use of analgesic or opioid within 24 hours of onset of headache to be treated with study medication. (If subject has an eligible headache and has taken a triptan or DHE within 24 hours, but greater than 2 hours before study drug dosing, they can be treated with study medication.)
  • Patients taking the following medications on a regular basis: warfarin, lithium, ACE-inhibitors, loop diuretics, thiazide diuretics, ARBs, and methotrexate.
  • Patients with active, clinically significant anemia
  • Patients with a history or evidence of asthma
  • Patients with a history heart failure
  • Subjects with severely impaired hepatic or renal function, as determined by the investigator
  • Patients with a history of allergy or hypersensitivity to any component of IVIb, aspirin (or aspirin related products), NSAIDs, or COX-2 inhibitors
  • Pregnant or nursing women
  • Patients who have a history of congenital bleeding diathesis (e.g., hemophilia) or any active clinically significant bleeding, or have underlying platelet dysfunction including (but not limited to) idiopathic thrombocytopenic purpura, disseminated intravascular coagulation, or congenital platelet dysfunction
  • Patients who have GI bleeding that required medical intervention within the previous 6 weeks (unless definitive surgery has been performed.)
  • Patients who have a platelet count less than 100,000, as determined within the 28 days prior to treatment
  • Pre-existing or current dependence on opioids.
  • Subjects who have participated in an investigational drug trial in the 30 days prior to the screening visit
  • Subjects with uncontrolled hypertension
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01230411


Contacts
Contact: Meryl Latsko, MD,MPH 215-955-9477 meryl.latsko@jefferson.edu
Contact: Kathleen Bradley, BSN, CCRP 215-955-2025 kathleen.bradlely@jefferson.edu

Locations
United States, Pennsylvania
Jefferson Headache Center Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Kathleen Bradley, BSN       kathleen.bradley@jefferson.edu   
Sponsors and Collaborators
Thomas Jefferson University
Investigators
Principal Investigator: Stephen D. Silberstein, M.D. Jefferson Headache Center
More Information

Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT01230411     History of Changes
Other Study ID Numbers: SDS/IVIb/01
First Posted: October 29, 2010    Key Record Dates
Last Update Posted: June 14, 2016
Last Verified: June 2016

Keywords provided by Thomas Jefferson University:
Episodic migraine

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
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