Comparing Naproxen to Sumatriptan for Emergency Headache Patients (HEDNet2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Benjamin Friedman, Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT00449787
First received: March 19, 2007
Last updated: October 29, 2012
Last verified: October 2012
Results First Received: July 13, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Migraine
Tension-type Headache
Primary Headache Disorder
Interventions: Drug: Sumatriptan 100 mg
Drug: Naproxen

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Sumatriptan Sumatriptan 100 mg tablet
Naproxen Naproxen 500 mg tablet

Participant Flow:   Overall Study
    Sumatriptan     Naproxen  
STARTED     203     198  
COMPLETED     98     98  
NOT COMPLETED     105     100  
Lost to Follow-up                 10                 8  
Did not require medication                 95                 92  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Sumatriptan Sumatriptan 100 mg tablet
Naproxen Naproxen 500 mg tablet
Total Total of all reporting groups

Baseline Measures
    Sumatriptan     Naproxen     Total  
Number of Participants  
[units: participants]
  203     198     401  
Age  
[units: years]
Mean ± Standard Deviation
  36  ± 10     35  ± 10     36  ± 10  
Gender  
[units: participants]
     
Female     173     168     341  
Male     30     30     60  



  Outcome Measures
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1.  Primary:   Numerical Rating Scale   [ Time Frame: Baseline, two hours ]

2.  Secondary:   Headache-related Functional Disability   [ Time Frame: Baseline, two hours ]

3.  Secondary:   Patient Satisfaction   [ Time Frame: 48 hours after ER discharge ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Benjamin Friedman
Organization: Montefiore Medical Center
phone: 718-920-6626
e-mail: bwfriedmanmd@gmail.com


No publications provided


Responsible Party: Benjamin Friedman, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT00449787     History of Changes
Other Study ID Numbers: HEDNet2
Study First Received: March 19, 2007
Results First Received: July 13, 2011
Last Updated: October 29, 2012
Health Authority: United States: Institutional Review Board