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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: Clinical Trial Phase 3 study, sponsored by POZEN.
NCT00594854 is a Phase 3 study that was terminated before completion, run by POZEN. The registered enrollment target is 20 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Number of participants with gastric ulcers confirmed by endoscopy following administration of PN 400 (VIMOVO) or Arthrotec in a high risk population over six months.
Interventions
- DRUG PN400 (VIMOVO)
- DRUG Diclofenac/Misoprostol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2007-09 |
| Est. Completion | 2008-09 |
| Phase | Phase 3 |
Why NCT00594854 stopped before completion
NCT00594854 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which PN400 (VIMOVO) is the first listed.
NCT00594854 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00594854's enrollment target sits among peer trials
20 1956th of 2000 higher than 32 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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