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

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

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.

Study Overview

• Status: Completed
• Conditions: Intragastric Acidity
• Intervention / Treatment: Drug: Zegerid; Drug: Prilosec OTC™ Tablets; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: February 25, 2010
• First Submitted That Met QC Criteria: February 25, 2010
• First Posted (Estimate): February 26, 2010

Study Record Updates

• Last Update Posted (Estimate): March 11, 2015
• Last Update Submitted That Met QC Criteria: February 20, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: Human Experimentation; Gastric Acid
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Omeprazole; Omeprazole, sodium bicarbonate drug combination
• Other Study ID Numbers: 18132; P07812 (Other Identifier: Merck)