Trial Outcomes & Findings for Comparing Naproxen to Sumatriptan for Emergency Headache Patients (NCT NCT00449787)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

401 participants

Primary outcome timeframe

Baseline, two hours

Results posted on

2018-05-31

Participant Flow

Participant milestones

Participant milestones
Measure	Sumatriptan Sumatriptan 100 mg tablet	Naproxen Naproxen 500 mg tablet
Overall Study STARTED	203	198
Overall Study COMPLETED	98	98
Overall Study NOT COMPLETED	105	100

Reasons for withdrawal

Reasons for withdrawal
Measure	Sumatriptan Sumatriptan 100 mg tablet	Naproxen Naproxen 500 mg tablet
Overall Study Lost to Follow-up	10	8
Overall Study Did not require medication	95	92

Baseline Characteristics

Comparing Naproxen to Sumatriptan for Emergency Headache Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sumatriptan n=203 Participants Sumatriptan 100 mg tablet	Naproxen n=198 Participants Naproxen 500 mg tablet	Total n=401 Participants Total of all reporting groups
Age, Continuous	36 years STANDARD_DEVIATION 10 • n=5 Participants	35 years STANDARD_DEVIATION 10 • n=7 Participants	36 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	173 Participants n=5 Participants	168 Participants n=7 Participants	341 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, two hours

Population: 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

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

Outcome measures

Outcome measures
Measure	Sumatriptan n=98 Participants Sumatriptan 100mg tablet	Naproxen n=98 Participants Naproxen 500mg tablet
Numerical Rating Scale	4.1 units on a scale Standard Deviation 3.1	4.3 units on a scale Standard Deviation 3.0

SECONDARY outcome

Timeframe: Baseline, two hours

Population: Patients who reported any level of functional impairment (mild, moderate, or severe) are tabulated here.

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.

Outcome measures

Outcome measures
Measure	Sumatriptan n=98 Participants Sumatriptan 100mg tablet	Naproxen n=97 Participants Naproxen 500mg tablet
Headache-related Functional Disability	41 participants	36 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Sumatriptan n=92 Participants Sumatriptan 100mg tablet	Naproxen n=96 Participants Naproxen 500mg tablet
Patient Satisfaction	69 participants	68 participants

Adverse Events

Sumatriptan

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

Naproxen

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Sumatriptan n=97 participants at risk；n=98 participants at risk Sumatriptan 100 mg tablet	Naproxen n=97 participants at risk；n=98 participants at risk Naproxen 500 mg tablet
Musculoskeletal and connective tissue disorders Other	12.4% 12/97 • Number of events 12	0.00% 0/97
Gastrointestinal disorders Gastrointestinal complaint	9.3% 9/97 • Number of events 9	7.2% 7/97 • Number of events 7
Nervous system disorders Neurological	4.1% 4/97 • Number of events 4	11.3% 11/97 • Number of events 11

Additional Information

Benjamin Friedman

Montefiore Medical Center

Phone: 718-920-6626

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place