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NCT00045799 · ClinicalTrials.gov registry record · Phase 3
Safety & Efficacy of Omeprazole Sodium Bicarbonate for the Prevention of Upper GI Bleeding in the Critically Ill
A Phase 3 study, sponsored by Bausch Health Americas.
- Completed
- Registry status
- Phase 3
- Development phase
- 354
- Enrollment target
NCT00045799: Completed Phase 3 study, sponsored by Bausch Health Americas.
NCT00045799 is a Phase 3 study that has completed, run by Bausch Health Americas. The registered enrollment target is 354 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (54% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00045799, a Phase 3 study, has completed, sponsored by Bausch Health Americas.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 354 participants
- Enrollment target
Study Summary
Critically ill patients are at an increased risk of having upper gastrointestinal (GI) bleeding due to stress related mucosal damage. Cimetidine, delivered continuously through intravenous infusion, is the only drug that the FDA has approved for the prevention of upper GI bleeding in critically ill patients. The present trial is intended to assess the safety and efficacy of an omeprazole sodium bicarbonate immediate-release suspension in this indication.
Interventions
- DRUG Omeprazole sodium bicarbonate immediate release PWD/FS
- DRUG Cimetidine IV
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 354 participants |
| Start Date | 2002-05 |
| Est. Completion | 2003-05 |
| Phase | Phase 3 |
What the finished NCT00045799 record still lists
NCT00045799 is an interventional study that assigns participants to a tested intervention. The registered 354 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 (54% lower).
The record links to 0 conditions, and to 2 interventions - of which Omeprazole sodium bicarbonate immediate release PWD/FS is the first listed.
NCT00045799 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00045799 about?
NCT00045799 is a clinical study titled "Safety & Efficacy of Omeprazole Sodium Bicarbonate for the Prevention of Upper GI Bleeding in the Critically Ill". Critically ill patients are at an increased risk of having upper gastrointestinal (GI) bleeding due to stress related mucosal damage. Cimetidine, delivered continuously through intravenous infusion, is the only drug that the FDA has approved for the prevention of upper GI bleeding in critically ill ...
What is the current status of trial NCT00045799?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 354 participants. The study started on 2002-05. Estimated completion is 2003-05.
What interventions are being tested in trial NCT00045799?
The interventions under investigation include: Omeprazole sodium bicarbonate immediate release PWD/FS (DRUG), Cimetidine IV (DRUG).
Who is sponsoring clinical trial NCT00045799?
This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00045799's enrollment target sits among peer trials
354 1026th of 2000 higher than 973 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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