CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 60 enrolled
Drug / intervention
Omeprazole/sodium bicarbonate +2 moredrug
Likely dose
omeprazole magnesium 20 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00674115
NCT00674115Phase 3Completed
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Randomized, Crossover Pharmacodynamic Study Comparing the Effects of Zegerid® (20 mg Omeprazole/Sodium Bicarbonate) and Prilosec OTC® (20 Mg-equivalent Omeprazole)

Bayer·interventional·Posted May 7, 2008·Updated Mar 11, 2015

In Brief

A Phase 3 clinical trial evaluating Omeprazole/sodium bicarbonate, omeprazole magnesium, and 1 other intervention for Gastric Acid and Human Experimentation. Completed, enrolled 60 participants.

Detailed Summary

Open-label randomized crossover design studies. 60 participants will be evaluated on Day 1 to compare effects on stomach acid; 30 participants will continue treatment for 7 days and will have repeat evaluations at Day 7. The other 30 participants will receive a single administration of sodium bicarbonate.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastric Acid, Human Experimentation
Countries--
CollaboratorsBausch Health Americas, Inc.

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 7, 2008
Enrollment StartApr 1, 2008
Primary CompletionJun 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 18.2 years ago

Interventions

Omeprazole/sodium bicarbonatedrug

Omeprazole/sodium bicarbonate. Single dose per day for either 1 or 7 days.

omeprazole magnesiumdrug

Omeprazole 20 mg tablet. Single dose per day for either 1 or 7 days.

sodium bicarbonatedrug

Sodium bicarbonate. Single dose.