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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 is a Phase 3 study that has completed, run by Bausch Health Americas. The registered enrollment target is 354 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00045799
The ClinicalTrials.gov registry entry for NCT00045799 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 354 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bausch Health Americas, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Omeprazole sodium bicarbonate immediate release PWD/FS is the first listed.
NCT00045799 reports 0 study locations.
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.
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