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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Migraine
Tension-type Headache
Primary Headache Disorder
Interventions Drug: Sumatriptan 100 mg
Drug: Naproxen
Enrollment 401
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sumatriptan Naproxen
Hide Arm/Group Description Sumatriptan 100 mg tablet Naproxen 500 mg tablet
Period Title: Overall Study
Started 203 198
Completed 98 98
Not Completed 105 100
Reason Not Completed
Lost to Follow-up             10             8
Did not require medication             95             92
Arm/Group Title Sumatriptan Naproxen Total
Hide Arm/Group Description Sumatriptan 100 mg tablet Naproxen 500 mg tablet Total of all reporting groups
Overall Number of Baseline Participants 203 198 401
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 203 participants 198 participants 401 participants
36  (10) 35  (10) 36  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 203 participants 198 participants 401 participants
Female
173
  85.2%
168
  84.8%
341
  85.0%
Male
30
  14.8%
30
  15.2%
60
  15.0%
1.Primary Outcome
Title Numerical Rating Scale
Hide Description

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

Time Frame Baseline, two hours
Hide Outcome Measure Data
Hide Analysis Population Description
After discharge from the emergency room, some patients had headache requiring use of medication and some did not. Only those patients who took the investigational medication were included in the analysis
Arm/Group Title Sumatriptan Naproxen
Hide Arm/Group Description:
Sumatriptan 100mg tablet
Naproxen 500mg tablet
Overall Number of Participants Analyzed 98 98
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.1  (3.1) 4.3  (3.0)
2.Secondary Outcome
Title Headache-related Functional Disability
Hide Description 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.
Time Frame Baseline, two hours
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who reported any level of functional impairment (mild, moderate, or severe) are tabulated here.
Arm/Group Title Sumatriptan Naproxen
Hide Arm/Group Description:
Sumatriptan 100mg tablet
Naproxen 500mg tablet
Overall Number of Participants Analyzed 98 97
Measure Type: Number
Unit of Measure: participants
41 36
3.Secondary Outcome
Title Patient Satisfaction
Hide Description 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.
Time Frame 48 hours after ER discharge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sumatriptan Naproxen
Hide Arm/Group Description:
Sumatriptan 100 mg tablet
Naproxen 500 mg tablet
Overall Number of Participants Analyzed 92 96
Measure Type: Number
Unit of Measure: participants
69 68
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sumatriptan Naproxen
Hide Arm/Group Description Sumatriptan 100 mg tablet Naproxen 500 mg tablet
All-Cause Mortality
Sumatriptan Naproxen
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Sumatriptan Naproxen
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/98 (0.00%)      0/98 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Sumatriptan Naproxen
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   25/97 (25.77%)      18/97 (18.56%)    
Gastrointestinal disorders     
Gastrointestinal complaint * [1]  9/97 (9.28%)  9 7/97 (7.22%)  7
Musculoskeletal and connective tissue disorders     
Other * [2]  12/97 (12.37%)  12 0/97 (0.00%)  0
Nervous system disorders     
Neurological * [3]  4/97 (4.12%)  4 11/97 (11.34%)  11
*
Indicates events were collected by non-systematic assessment
[1]
nausea, vomiting, epigastric pain, or diarrhea
[2]
Various non-serious adverse events including myalgia, facial pains, and non-specific complaints
[3]
Dizzy, lightheaded, non-specific weakness, drowsy, headache
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Benjamin Friedman
Organization: Montefiore Medical Center
Phone: 718-920-6626
EMail: bwfriedmanmd@gmail.com
Layout table for additonal information
Responsible Party: Benjamin W. Friedman, MD, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT00449787     History of Changes
Other Study ID Numbers: 06-11-472
First Submitted: March 19, 2007
First Posted: March 21, 2007
Results First Submitted: July 13, 2011
Results First Posted: November 29, 2012
Last Update Posted: May 31, 2018