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An RCT to Compare Naproxen to Sumatriptan for Headache Patients Discharged (HEDNet2)
This study is ongoing, but not recruiting participants.
First Received: March 19, 2007   Last Updated: October 27, 2009   History of Changes
Sponsor: Montefiore Medical Center
Information provided by: Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT00449787
  Purpose

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 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.


Condition Intervention Phase
Migraine
Tension-Type Headache
Primary Headache Disorder
Drug: Sumatriptan 100mg
Drug: Naproxen
Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title: An RCT to Compare Naproxen and Sumatriptan for Headache Patients Discharged From the Emergency Department

Resource links provided by NLM:


Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:
  • Pain intensity score [ Time Frame: 48 hours after ED discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse effects [ Time Frame: 48 hours after ED discharge ] [ Designated as safety issue: Yes ]
  • Headache-related functional disability [ Time Frame: 48 Hours after ED discharge ] [ Designated as safety issue: No ]
  • Patient satisfaction [ Time Frame: 48 hours after ED discharge ] [ Designated as safety issue: No ]

Estimated Enrollment: 352
Study Start Date: March 2007
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sumatriptan: Active Comparator
Sumatriptan 100mg po
Drug: Sumatriptan 100mg
Sumatriptan 100mg po
Naproxen: Active Comparator
Naproxen 500mg po
Drug: Naproxen
Naproxen 500mg po

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 and which is more efficacious for the subset of headache patients with an acute migraine.
  2. To determine the feasibility of grouping all primary headache disorder patients into one category for analysis.

Primary hypotheses:

1A. In the 48 hour period following ED treatment for migraine, sumatriptan 100mg will relieve pain better than naproxen 500mg, as measured by an 11-point numerical rating scale for pain.

1B. 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.

2. Methodology hypothesis: When compared to those subjects with an acute migraine, "headache" patients who do not meet International Headache Society migraine criteria will demonstrate similar variability in response to treatment.

  Eligibility

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

Inclusion Criteria:

  • Treated in the emergency department for acute primary headache

Exclusion Criteria:

  • Allergy, intolerance, or contra-indication to one of the study medications
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00449787

Locations
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Montefiore Medical Center
Investigators
Principal Investigator: Benjamin W. Friedman, MD,MS Albert Einstein College of Medicine of Yeshiva University
  More Information

No publications provided

Responsible Party: Montefiore Medical Center ( Benjamin Friedman )
Study ID Numbers: HEDNet2
Study First Received: March 19, 2007
Last Updated: October 27, 2009
ClinicalTrials.gov Identifier: NCT00449787     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Montefiore Medical Center:
Emergency department
headache
migraine

Additional relevant MeSH terms:
Serotonin Agonists
Anti-Inflammatory Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Pain
Headache Disorders, Primary
Brain Diseases
Gout Suppressants
Headache Disorders
Signs and Symptoms
Migraine Disorders
Sensory System Agents
Therapeutic Uses
Headache
Vasoconstrictor Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Naproxen
Tension-Type Headache
Nervous System Diseases
Cyclooxygenase Inhibitors
Central Nervous System Diseases
Enzyme Inhibitors
Cardiovascular Agents
Pharmacologic Actions
Sumatriptan
Serotonin Agents
Analgesics, Non-Narcotic
Neurologic Manifestations

ClinicalTrials.gov processed this record on November 09, 2009