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Comparing Naproxen to Sumatriptan for Emergency Headache Patients (HEDNet2)

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ClinicalTrials.gov Identifier: NCT00449787
Recruitment Status : Completed
First Posted : March 21, 2007
Results First Posted : November 29, 2012
Last Update Posted : May 31, 2018
Sponsor:
Information provided by (Responsible Party):
Benjamin W. Friedman, MD, Montefiore Medical Center

Tracking Information
First Submitted Date  ICMJE March 19, 2007
First Posted Date  ICMJE March 21, 2007
Results First Submitted Date  ICMJE July 13, 2011
Results First Posted Date  ICMJE November 29, 2012
Last Update Posted Date May 31, 2018
Study Start Date  ICMJE March 2007
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 29, 2012)
Numerical Rating Scale [ Time Frame: Baseline, two hours ]
Within 48 hours of ED discharge, participants were allowed to take the investigational medication. At the moment they took the investigational medication, they were asked to record a number from 0 to 10, which represented their headache. 0 signified no pain and 10 signified the worse pain imaginable. Two hours later, participants were asked again to record their pain on a scale from 0 to 10. The outcome is the change in pain between baseline and two hours and will be a number between 0 and 10. Greater numbes signify greater relief
Original Primary Outcome Measures  ICMJE
 (submitted: March 19, 2007)
Pain intensity score
Change History Complete list of historical versions of study NCT00449787 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 29, 2012)
  • Headache-related Functional Disability [ Time Frame: Baseline, two hours ]
    This is a recommend outcome in headache research. At the time of the assessment (48 hours after ER discharge), patients are asked to report their current level of functional impairment: severe (unable to do any activities); moderate (able to do a few activities); mild (able to do many but not all activities) or none (able to do all activities). For this analysis, patient's answers were dichotomized into some impairment or no impairment.
  • Patient Satisfaction [ Time Frame: 48 hours after ER discharge ]
    At the 48 hour assessment, patients were asked, "The next time you go to an emergency room with a headache, do you want to receive the same medication". This outcome tabulates the number of affirmative responses.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2007)
  • Advere effects
  • Headache-related Functional Disability
  • Patient Satisfaction
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparing Naproxen to Sumatriptan for Emergency Headache Patients
Official Title  ICMJE A Randomized Clinical Trial to Compare Naproxen and Sumatriptan for Headache Patients Discharged From the Emergency Department (ED)
Brief Summary 2/3 of patients discharged from an emergency department after treatment for an acute headache will still be bothered by headache within 24 hours of emergency department (ED) treatment. The goal of this study is to compare two medications, naproxen and sumatriptan, to determine which is better for the treatment of recurrent headache within 24 hours of emergency department discharge.
Detailed Description

Two-thirds of the five million headache patients who present to US emergency departments (ED) annually are suffering an acute exacerbation of a primary headache disorder. Of these acute primary headaches, migraine is the most frequently encountered disease entity in the ED, accounting for 60% of primary headaches, followed by tension-type headaches, which represent 10% of all primary headaches seen in the ED. About ¼ of all acute primary headaches seen in the ED cannot readily be given a specific diagnosis3. Multiple parenteral treatments are used to treat acute primary headaches1, but to date, regardless of specific headache diagnosis, no medication eliminates the frequent recurrence of headache after ED discharge. To date, it is unknown which medication patients should be given when discharged from an ED after treatment for a primary headache. This study will compare two oral headache treatments to determine which one relives pain more effectively.

Specific aims:

1) To determine which of two oral medications is more efficacious for all acute primary headache patients who are discharged from an ED.

Primary hypotheses:

In the 48 hour period following ED treatment for a primary headache, sumatriptan 100mg will relieve pain better than naproxen 500mg, as measured by an 11-point numerical rating scale for pain.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Migraine
  • Tension-type Headache
  • Primary Headache Disorder
Intervention  ICMJE
  • Drug: Sumatriptan 100 mg
    Sumatriptan 100mg tablet
  • Drug: Naproxen
    Naproxen 500mg tablet
Study Arms  ICMJE
  • Active Comparator: Sumatriptan
    Sumatriptan 100 mg tablet
    Intervention: Drug: Sumatriptan 100 mg
  • Active Comparator: Naproxen
    Naproxen 500 mg tablet
    Intervention: Drug: Naproxen
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 29, 2012)
401
Original Enrollment  ICMJE
 (submitted: March 19, 2007)
352
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Treated in the emergency department for acute primary headache

Exclusion Criteria:

  • Allergy, intolerance, or contra-indication to one of the study medications
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00449787
Other Study ID Numbers  ICMJE 06-11-472
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Benjamin W. Friedman, MD, Montefiore Medical Center
Study Sponsor  ICMJE Montefiore Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Benjamin W. Friedman, MD,MS Albert Einstein College of Medicine
PRS Account Montefiore Medical Center
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP