Phase 4
N=40
Comparison of Prilosec Over-the-counter (OTC)® Versus Prevacid® for Gastric Acid Suppression
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT00903448 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Nov 2010
Primary outcome: Primary: Mean Percent Time That Gastric pH > 4.0 on Day 5 — 36.8; 45.7 percent time gastric pH exceeds 4.0 — p=< 0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Prilosec OTC (omeprazole-magnesium) (Drug); Prevacid (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Procter and Gamble
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Percent Time That Gastric pH > 4.0 on Day 5 |
36.8; 45.7 | < 0.0001 sig |
Summary
The objective of this study is to compare Prilosec OTC® to Prevacid® for gastric acid suppression.
Eligibility Criteria
Inclusion Criteria
- normal subjects who are age 18-65
- generally healthy
- non-childbearing potential females or those using birth control
Exclusion Criteria
- history of significant GI disease
- any significant medical illness
- history of hypersensitivity, allergy or intolerance to omeprazole, lansoprazole or other proton pump inhibitors
- currently using GI medications
- GI disorder or surgery leading to impaired drug absorption
Data sourced from ClinicalTrials.gov (NCT00903448). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.