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NCT00442221 · ClinicalTrials.gov registry record · Phase 3

The Safety Of Combo Formulation In The Treatment Of Multiple Episodes Of Acute Migraine Over 12 Months

A Phase 3 study, sponsored by POZEN.

Completed
Registry status
Phase 3
Development phase
500
Enrollment target

NCT00442221: Completed Phase 3 study, sponsored by POZEN.

NCT00442221 is a Phase 3 study that has completed, run by POZEN. The registered enrollment target is 500 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00442221, a Phase 3 study, has completed, sponsored by POZEN.

COMPLETED
Registry status
Phase 3
Development phase
500 participants
Enrollment target

Study Summary

The objective of this study is to assess the safety of a single-tablet dose of Combo Formulation for the treatment of moderate to severe migraines

Interventions

  • DRUG Sumatriptan and Naproxen sodium

Trial Details

FieldValue
Enrollment Target 500 participants
Start Date 2004-05
Est. Completion 2004-08
Phase Phase 3
POZEN

24 total trials

What the finished NCT00442221 record still lists

NCT00442221 is an interventional study that assigns participants to a tested intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% lower).

The record links to 0 conditions, and to 1 intervention - of which Sumatriptan and Naproxen sodium is the first listed.

NCT00442221 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00442221 about?

NCT00442221 is a clinical study titled "The Safety Of Combo Formulation In The Treatment Of Multiple Episodes Of Acute Migraine Over 12 Months". The objective of this study is to assess the safety of a single-tablet dose of Combo Formulation for the treatment of moderate to severe migraines

What is the current status of trial NCT00442221?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 500 participants. The study started on 2004-05. Estimated completion is 2004-08.

What interventions are being tested in trial NCT00442221?

The interventions under investigation include: Sumatriptan and Naproxen sodium (DRUG).

Who is sponsoring clinical trial NCT00442221?

This trial is sponsored by POZEN, which has 24 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00442221's enrollment target sits among peer trials

500 744th of 2000 higher than 1,226 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT00442221, the US trial registry maintained by the National Library of Medicine. NCT00442221 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.