Conditions: Intragastric Acidity
Keywords: Gastric Acid Human Experimentation
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 30
Healthy volunteers: yes

Brief summary:
This randomized, crossover study is to evaluate the early effectiveness, defined as effect on intragastric pH during the first 4 hours after dosing, of Zegerid, Prilosec over-the-counter (OTC) Tablets, and placebo on the 4th day of treatment to inhibit acid secretion. Additional purposes are to:

1. provide pharmacodynamic evidence comparing 24-hr inhibition of acid secretion on the 1st, 4th, and 11th days of dosing with each of the indicated treatments;
2. compare Zegerid and Prilosec OTC for achieving their steady-state effects for controlling 24-hr gastric acidity at steady-state on the 4th and 11th day of dosing.
3. evaluate early effectiveness, defined as effect on intragastric pH during the first 4 hours after administration, of Zegerid, Prilosec OTC Tablets, and placebo on acid inhibition at steady-state when administered on the 11th day of dosing.

Detailed description:
Participants were randomized in a 3-way crossover design and received, in random order, Zegerid OTC Capsules (20 mg omeprazole and 1100 mg sodium bicarbonate), Prilosec OTC Tablets (20 mg-equivalent omeprazole), and Placebo Capsules. Participants received each treatment for 11 days. There was a minimum of a 2-week washout period between treatment arms.

Arms:
arm 1: 20 mg omeprazole and 1100 mg sodium bicarbonate arm 2: 20.6 mg omeprazole-magnesium complex. arm 3: Inert substance

Interventions: intervention 1: Zegerid intervention 2: Prilosec OTC™ Tablets intervention 3: Placebo
Intervention descriptions: intervention 1: Zegerid taken once daily for 11 days. intervention 2: Prilosec OTC™ Tablets taken once daily for 11 days. intervention 3: Placebo taken once daily for 11 days.

Protocol document: