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NCT00449787 · ClinicalTrials.gov registry record · Phase 4

Comparing Naproxen to Sumatriptan for Emergency Headache Patients

A Phase 4 study, sponsored by Montefiore Medical Center.

Completed
Registry status
Phase 4
Development phase
401
Enrollment target

NCT00449787: Completed Phase 4 study, sponsored by Montefiore Medical Center.

NCT00449787 is a Phase 4 study that has completed, run by Montefiore Medical Center. The registered enrollment target is 401 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00449787, a Phase 4 study, has completed, sponsored by Montefiore Medical Center.

COMPLETED
Registry status
Phase 4
Development phase
401 participants
Enrollment target

Study Summary

2/3 of patients discharged from an emergency department after treatment for an acute headache will still be bothered by headache within 24 hours of emergency department (ED) treatment. The goal of this study is to compare two medications, naproxen and sumatriptan, to determine which is better for the treatment of recurrent headache within 24 hours of emergency department discharge.

Primary Outcome

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.

Interventions

  • DRUG Naproxen
  • DRUG Sumatriptan 100 mg

Trial Details

FieldValue
Enrollment Target 401 participants
Start Date 2007-03
Est. Completion 2009-07
Phase Phase 4
Montefiore Medical Center

345 total trials

What the finished NCT00449787 record still lists

NCT00449787 is an interventional study that assigns participants to a tested intervention. The registered 401 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (23% lower).

The record links to 0 conditions, and to 2 interventions - of which Naproxen is the first listed.

NCT00449787 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00449787 about?

NCT00449787 is a clinical study titled "Comparing Naproxen to Sumatriptan for Emergency Headache Patients". 2/3 of patients discharged from an emergency department after treatment for an acute headache will still be bothered by headache within 24 hours of emergency department (ED) treatment. The goal of this study is to compare two medications, naproxen and sumatriptan, to determine which is better for th...

What is the current status of trial NCT00449787?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 401 participants. The study started on 2007-03. Estimated completion is 2009-07.

What interventions are being tested in trial NCT00449787?

The interventions under investigation include: Naproxen (DRUG), Sumatriptan 100 mg (DRUG).

Who is sponsoring clinical trial NCT00449787?

This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00449787's enrollment target sits among peer trials

401 210th of 2000 higher than 1,790 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00449787, the US trial registry maintained by the National Library of Medicine. NCT00449787 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.