Pharmacodynamic Study Comparing the Effects of Two Different Forms of Omeprazole (P07812) (COMPLETED)

Study Overview
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Brief Summary
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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: 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; 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. 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
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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.

Official Title
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Randomized, Placebo-Controlled, Crossover Pharmacodynamic Study Comparing the Effects of Two Different Forms of Omeprazole

Conditions
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Intragastric Acidity

Intervention / Treatment
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* Drug: Zegerid
* Drug: Prilosec OTC™ Tablets
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or non-lactating, non-pregnant female subjects who are 18-65 years of age. Physical examination findings within normal limits for age. Exclusion Criteria: History of hypersensitivity, allergy or intolerance to omeprazole, or other proton pump inhibitors History of peptic ulcer disease or other acid related gastrointestinal symptoms or heartburn with a frequency of more than one/month. Participation in any study of an investigational treatment in the 30 Days before Screening or participation in another study at any time during the period of this study Any significant medical illness that would contraindicate participation in the study Gastrointestinal disorder or surgery leading to impaired drug absorption Any abnormal Screening laboratory value that is clinically significant in the investigator's opinion Current use of any prescription or OTC medications that affect gastrointestinal function. Currently using or having a history of frequent use of antacids, OTC or prescription (Rx) histamine-2 (H2) receptor antagonists, or OTC or Rx use of proton pump inhibitors.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zegerid OTC Capsules<br>20 mg omeprazole and 1100 mg sodium bicarbonate | Drug: Zegerid<br>* Zegerid taken once daily for 11 days.<br>|
| Active Comparator: Prilosec OTC™ tablets containing 20 mg-equivalent omeprazole<br>20.6 mg omeprazole-magnesium complex. | Drug: Prilosec OTC™ Tablets<br>* Prilosec OTC™ Tablets taken once daily for 11 days.<br>|
| Placebo Comparator: Placebo<br>Inert substance | Other: Placebo<br>* Placebo taken once daily for 11 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Time With Intragastric pH>4 During the First 4 Hours Following Administration on Day 4 of Treatment | Early effectiveness of treatment is evaluated as the percent time with intragastric pH>4 during the first 4 hours following administration of respective treatments | 4 hours after dose on Day 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastric Acid, Human Experimentation