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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2007-09 |
| Est. Completion | 2008-09 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗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.
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