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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 
Overall Participants Analyzed 
[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


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


Results Point of Contact:  
Name/Title: Benjamin Friedman
Organization: Montefiore Medical Center
phone: 718-920-6626
e-mail: bwfriedmanmd@gmail.com



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