At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 60 enrolled
Drug / intervention
Omeprazole/sodium bicarbonate +1 moredrug
Likely dose
omeprazole magnesium (20 mg equivalent)from 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.
Randomized, Crossover Pharmacodynamic Study Comparing the Effects of Zegerid® (20 mg Omeprazole/Sodium Bicarbonate) and Prilosec OTC® Tablets (20 Mg-equivalent Omeprazole)
In Brief
A Phase 3 clinical trial evaluating Omeprazole/sodium bicarbonate and omeprazole magnesium (20 mg equivalent) for Gastric Acid and Human Experimentation. Completed, enrolled 60 participants.
Detailed Summary
Open-label randomized crossover design study. 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastric Acid, Human Experimentation
Countries--
CollaboratorsBausch Health Americas, Inc.
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2008
Primary CompletionAug 2008
First PostedOct 2008
TodayJul 2026
First PostedOct 2, 2008
Enrollment StartMay 1, 2008
Primary CompletionAug 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 17.8 years ago
Interventions
Omeprazole/sodium bicarbonatedrug
Single dose of omeprazole/sodium bicarbonate per day for either 1 or 7 days.
omeprazole magnesium (20 mg equivalent)drug
Single dose of omeprazole magnesium per day for either 1 or 7 days.