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NCT00492622 · ClinicalTrials.gov registry record · Phase 4
Pharmacokinetics of Immediate-Release vs. Delayed-Release Omeprazole in Gastroparesis
A Phase 4 study, sponsored by University of Louisville.
- Completed
- Registry status
- Phase 4
- Development phase
- 12
- Enrollment target
NCT00492622: Completed Phase 4 study, sponsored by University of Louisville.
NCT00492622 is a Phase 4 study that has completed, run by University of Louisville. The registered enrollment target is 12 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00492622, a Phase 4 study, has completed, sponsored by University of Louisville.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 12 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the blood drug levels of two prescribed medications, immediate-release omeprazole 40 mg powder and delayed-release omeprazole 40 mg capsule to determine which drug is better absorbed in patients with a slow stomach emptying (gastroparesis). Delayed-release omeprazole has a protective coating to prevent the drug omeprazole from being neutralized by stomach acid. Immediate-release omeprazole has sodium bicarbonate (antacid) which neutralizes the stomach acid, eliminating the need for a protective coating. Immediate-release omeprazole suspension may have a more rapid pharmacokinetic profile and greater overall drug absorption in gastroparesis.
Primary Outcome
Time to max concentration for Immediate release vs. Delayed release omeprazole
Interventions
- DRUG Immediate-release omeprazole
- DRUG Delayed-release omeprazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2007-06 |
| Est. Completion | 2008-12 |
| Phase | Phase 4 |
What the finished NCT00492622 record still lists
NCT00492622 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Immediate-release omeprazole is the first listed.
NCT00492622 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00492622 about?
NCT00492622 is a clinical study titled "Pharmacokinetics of Immediate-Release vs. Delayed-Release Omeprazole in Gastroparesis". The purpose of this study is to compare the blood drug levels of two prescribed medications, immediate-release omeprazole 40 mg powder and delayed-release omeprazole 40 mg capsule to determine which drug is better absorbed in patients with a slow stomach emptying (gastroparesis). Delayed-release ome...
What is the current status of trial NCT00492622?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 12 participants. The study started on 2007-06. Estimated completion is 2008-12.
What interventions are being tested in trial NCT00492622?
The interventions under investigation include: Immediate-release omeprazole (DRUG), Delayed-release omeprazole (DRUG).
Who is sponsoring clinical trial NCT00492622?
This trial is sponsored by University of Louisville, which has 217 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00492622's enrollment target sits among peer trials
12 1913th of 2000 higher than 70 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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