A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC®

Condition(s) targeted: Gastric Acid; Human Experimentation

Intervention: Omeprazole/sodium bicarbonate (Drug); omeprazole magnesium (Drug); sodium bicarbonate (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Schering-Plough

Open-label randomized crossover design studies. 60 subjects will be evaluated on Day 1 to compare effects on stomach acid; 30 subjects will continue treatment for 7 days and will have repeat evaluations at Day 7.

Official title: Randomized, Crossover Pharmacodynamic Study Comparing the Effects of Zegerid® (20 mg Omeprazole/Sodium Bicarbonate) and Prilosec OTC® (20 mg-Equivalent Omeprazole)

Study design: Other, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacodynamics Study

Primary outcome: The primary outcome measure is the change from baseline in median 24-hr intragastric pH for Zegerid and Prilosec OTC on the 7th day of drug administration.

Secondary outcome:

Changes from baseline in median 24-hr intragastric pH on the 1st day of drug administration.

Changes from baseline of mean gastric acid concentration over 24-hrs on the 1st and 7th days of treatment.

Time to onset of inhibition of acid secretion on the first day of treatment.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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 GI disease

- Any significant medical illness

- Gastrointestinal disorder or surgery leading to impaired drug absorption

- Currently using GI medications

Starting date: April 2008
Ending date: June 2008
Last updated: May 2, 2008