Trial · NCT00449787
Comparing Naproxen to Sumatriptan for Emergency Headache Patients
NCT00449787, Phase 4, Completed, Montefiore Medical Center; results first posted 2012-11-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Comparing Naproxen to Sumatriptan for Emergency Headache Patients. Trials, record NCT00449787. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00449787
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparing Naproxen to Sumatriptan for Emergency Headache Patients
- NCT number
- NCT00449787
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 401 participants, actual
- Lead sponsor
- Montefiore Medical Center
- Conditions
- Migraine, Tension-type Headache, Primary Headache Disorder
- Interventions
- Sumatriptan 100 mg, Naproxen
- First posted
- 2007-03-21
- Last updated
- 2018-05-31
- Results first posted
- 2012-11-29
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Numerical Rating Scale | Baseline, two hours | 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 |
| Secondary | Headache-related Functional Disability | Baseline, two hours | 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. |
| Secondary | Patient Satisfaction | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Numerical Rating Scale | Baseline, two hours | 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 | units on a scale | MEAN |
| SECONDARY | Headache-related Functional Disability | Baseline, two hours | Patients who reported any level of functional impairment (mild, moderate, or severe) are tabulated here. | participants | NUMBER |
| SECONDARY | Patient Satisfaction | 48 hours after ER discharge | participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Numerical Rating Scale | Sumatriptan | 4.1 | Standard Deviation 3.1 | units on a scale | |
| Numerical Rating Scale | Naproxen | 4.3 | Standard Deviation 3.0 | units on a scale | |
| Headache-related Functional Disability | Sumatriptan | 41 | participants | ||
| Headache-related Functional Disability | Naproxen | 36 | participants | ||
| Patient Satisfaction | Sumatriptan | 69 | participants | ||
| Patient Satisfaction | Naproxen | 68 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sumatriptan | 203 | |
| Overall Study | STARTED | Naproxen | 198 | |
| Overall Study | COMPLETED | Sumatriptan | 98 | |
| Overall Study | COMPLETED | Naproxen | 98 | |
| Overall Study | NOT COMPLETED | Sumatriptan | 105 | |
| Overall Study | NOT COMPLETED | Naproxen | 100 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Other | Musculoskeletal and connective tissue disorders | Sumatriptan | 12 | 97 | 12 |
| other | Other | Musculoskeletal and connective tissue disorders | Naproxen | 0 | 97 | 0 |
| other | Gastrointestinal complaint | Gastrointestinal disorders | Sumatriptan | 9 | 97 | 9 |
| other | Gastrointestinal complaint | Gastrointestinal disorders | Naproxen | 7 | 97 | 7 |
| other | Neurological | Nervous system disorders | Sumatriptan | 4 | 97 | 4 |
| other | Neurological | Nervous system disorders | Naproxen | 11 | 97 | 11 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sumatriptan | ||
| Total, all-cause mortality | Naproxen | ||
| Total, other adverse events | Sumatriptan | 25 | 97 |
| Total, other adverse events | Naproxen | 18 | 97 |
| Total, serious adverse events | Sumatriptan | 0 | 98 |
| Total, serious adverse events | Naproxen | 0 | 98 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Sumatriptan vs Naproxen: Headache-related Functional Disability | Trial comparisons |
| Sumatriptan vs Naproxen: Patient Satisfaction | Trial comparisons |
| Sumatriptan vs Naproxen: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00449787
GET https://conductscience.org/api/trials/v1/NCT00449787/registered