Phase 3
Completed N=60
A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® (CL2007-17 )(P07813)(COMPLETED)
Gastric Acid · Human Experimentation
Source: ClinicalTrials.gov NCT00674115 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Apr 2010
Primary outcomePrimary: Change From Baseline in Median 24-hour Intragastric pH on the 7th Day of Drug Administration — 3.250; 4.160; 2.180; 2.900 pH scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Median 24-hour Intragastric pH on the 7th Day of Drug Administration |
3.250; 4.160; 2.180; 2.900 | — |
Eligibility Criteria
Inclusion Criteria
- Normal subjects who are 18-65 years of age.
- Non-childbearing potential females or those using birth control.
Exclusion Criteria
- History of hypersensitivity, allergy or intolerance to omeprazole or other proton pump inhibitors
- History of significant gastrointestinal disease
- Any significant medical illness
- Gastrointestinal disorder or surgery leading to impaired drug absorption
- Currently using gastrointestinal medications
Data sourced from ClinicalTrials.gov (NCT00674115). 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. Informational only — not medical advice.