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NCT00367211 · ClinicalTrials.gov registry record · Phase 3

Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PN 200 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated Ulcers.

A Phase 3 study, sponsored by POZEN.

Completed
Registry status
Phase 3
Development phase
400
Enrollment target

NCT00367211: Completed Phase 3 study, sponsored by POZEN.

NCT00367211 is a Phase 3 study that has completed, run by POZEN. The registered enrollment target is 400 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00367211, a Phase 3 study, has completed, sponsored by POZEN.

COMPLETED
Registry status
Phase 3
Development phase
400 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the incidence of gastric ulcers following administration of either PN 200 or Naproxen in subjects who are at risk for developing NSAID-associated ulcers.

Interventions

  • DRUG PN 200 tablets (500 mg naproxen and 20 mg omeprazole)
  • DRUG Naproxen 500 mg tablets (PN 200 minus omeprazole)

Trial Details

FieldValue
Enrollment Target 400 participants
Start Date 2006-09
Est. Completion 2007-09
Phase Phase 3
POZEN

24 total trials

What the finished NCT00367211 record still lists

NCT00367211 is an interventional study that assigns participants to a tested intervention. The registered 400 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 (48% lower).

The record links to 0 conditions, and to 2 interventions - of which PN 200 tablets (500 mg naproxen and 20 mg omeprazole) is the first listed.

NCT00367211 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00367211 about?

NCT00367211 is a clinical study titled "Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PN 200 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated Ulcers.". The purpose of this study is to evaluate the incidence of gastric ulcers following administration of either PN 200 or Naproxen in subjects who are at risk for developing NSAID-associated ulcers.

What is the current status of trial NCT00367211?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 400 participants. The study started on 2006-09. Estimated completion is 2007-09.

What interventions are being tested in trial NCT00367211?

The interventions under investigation include: PN 200 tablets (500 mg naproxen and 20 mg omeprazole) (DRUG), Naproxen 500 mg tablets (PN 200 minus omeprazole) (DRUG).

Who is sponsoring clinical trial NCT00367211?

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

How this trial's enrollment target compares

Where NCT00367211's enrollment target sits among peer trials

400 922nd of 2000 higher than 1,039 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 NCT00367211, the US trial registry maintained by the National Library of Medicine. NCT00367211 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.