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NCT00527787 · ClinicalTrials.gov registry record · Phase 3
Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers Compared to Non-steroidal Antiinflammatory Drug (NSAID) Naproxen
A Phase 3 study of Gastric Ulcer, sponsored by POZEN.
- Completed
- Registry status
- Phase 3
- Development phase
- 434
- Enrollment target
- 1
- Study location
NCT00527787: Completed Phase 3 study of Gastric Ulcer, sponsored by POZEN.
NCT00527787 is a Phase 3 study of Gastric Ulcer that has completed, run by POZEN. The registered enrollment target is 434 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (44% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00527787, a Phase 3 study of Gastric Ulcer, has completed, sponsored by POZEN.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 434 participants
- Enrollment target
- 1
- Study location
Study Summary
This study uses a randomized, double-blind, controlled design to demonstrate that PN400 (esomeprazole and naproxen) is more effective in reducing the occurrence of gastroduodenal ulcers, dyspepsia, and heartburn in subjects at risk for developing NSAID-associated gastric ulcers compared to naproxen alone.
Primary Outcome
The primary efficacy endpoint was the number of subjects with gastric ulcers at any time throughout 6 months of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter (measured by close application of open endoscopic biopsy forceps) with unequivocal crater depth. A subject is considered to have completed the study if all scheduled assessments up through the 6 month visit have been performed or if the endpoint of gastric ulcer confirmed by endoscopy has been reached.
Conditions Studied
Interventions
- DRUG Naproxen
- DRUG PN400 (VIMOVO)
Study Locations (1)
North Carolina
- POZEN - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 434 participants |
| Start Date | 2007-09 |
| Est. Completion | 2008-10 |
| Phase | Phase 3 |
What the finished NCT00527787 record still lists
NCT00527787 is an interventional study that assigns participants to a tested intervention. The registered 434 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 (44% lower).
The record links to 1 condition, with Gastric Ulcer appearing as the primary indexed condition, and to 2 interventions - of which Naproxen is the first listed.
NCT00527787 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT00527787 about?
NCT00527787 is a clinical study titled "Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers Compared to Non-steroidal Antiinflammatory Drug (NSAID) Naproxen". This study uses a randomized, double-blind, controlled design to demonstrate that PN400 (esomeprazole and naproxen) is more effective in reducing the occurrence of gastroduodenal ulcers, dyspepsia, and heartburn in subjects at risk for developing NSAID-associated gastric ulcers compared to naproxen ...
What is the current status of trial NCT00527787?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 434 participants. The study started on 2007-09. Estimated completion is 2008-10.
What conditions does trial NCT00527787 study?
This clinical trial studies the following conditions: Gastric Ulcer.
What interventions are being tested in trial NCT00527787?
The interventions under investigation include: Naproxen (DRUG), PN400 (VIMOVO) (DRUG).
Who is sponsoring clinical trial NCT00527787?
This trial is sponsored by POZEN, which has 24 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00527787 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Gastric Ulcer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00527787's enrollment target sits among peer trials
434 876th of 2000 higher than 1,125 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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