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NCT00594854 · ClinicalTrials.gov registry record · Phase 3

Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers in High Risk Subjects Compared to Arthrotec

A Phase 3 study, sponsored by POZEN.

Terminated
Registry status
Phase 3
Development phase
20
Enrollment target

NCT00594854 is a Phase 3 study that was terminated before completion, run by POZEN. The registered enrollment target is 20 participants.

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The verdict

NCT00594854, a Phase 3 study, was terminated before completion, sponsored by POZEN.

TERMINATED
Registry status
Phase 3
Development phase
20 participants
Enrollment target

Study Summary

This randomized, double-blind, parallel-group, controlled, multi-center clinical trial of 6 months duration is designed to assess the efficacy, tolerability and safety of PN400 versus diclofenac/misoprostol in subjects at high risk for developing NSAID-associated gastric ulcers. Approximately 100 sites will participate to enroll a total of 200 subjects (100 per arm). At least 20% of the subjects enrolled will be age 65 years and older.

Interventions

  • DRUG PN400 (VIMOVO)
  • DRUG Diclofenac/Misoprostol

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2007-09
Est. Completion 2008-09
Phase Phase 3

Sponsor

POZEN

24 total trials

What the Registry Record Tells You About NCT00594854

The ClinicalTrials.gov registry entry for NCT00594854 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is POZEN, which has 24 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which PN400 (VIMOVO) is the first listed.

NCT00594854 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00594854 about?

NCT00594854 is a clinical study titled "Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers in High Risk Subjects Compared to Arthrotec". This randomized, double-blind, parallel-group, controlled, multi-center clinical trial of 6 months duration is designed to assess the efficacy, tolerability and safety of PN400 versus diclofenac/misoprostol in subjects at high risk for developing NSAID-associated gastric ulcers. Approximately 100 si...

What is the current status of trial NCT00594854?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 20 participants. The study started on 2007-09. Estimated completion is 2008-09.

What interventions are being tested in trial NCT00594854?

The interventions under investigation include: PN400 (VIMOVO) (DRUG), Diclofenac/Misoprostol (DRUG).

Who is sponsoring clinical trial NCT00594854?

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

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.