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

NCT ID: NCT01077076

Last Updated: 2015-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2009-03-31

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.

Conditions

Intragastric Acidity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

Zegerid OTC Capsules

20 mg omeprazole and 1100 mg sodium bicarbonate

Group Type: EXPERIMENTAL

Zegerid

Intervention Type: DRUG

Zegerid taken once daily for 11 days.

Prilosec OTC™ tablets containing 20 mg-equivalent omeprazole

20.6 mg omeprazole-magnesium complex.

Group Type: ACTIVE_COMPARATOR

Prilosec OTC™ Tablets

Intervention Type: DRUG

Prilosec OTC™ Tablets taken once daily for 11 days.

Placebo

Inert substance

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo taken once daily for 11 days.

Interventions

Zegerid

Zegerid taken once daily for 11 days.

Intervention Type: DRUG

Prilosec OTC™ Tablets

Prilosec OTC™ Tablets taken once daily for 11 days.

Intervention Type: DRUG

Placebo

Placebo taken once daily for 11 days.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

P07812

Identifier Type: OTHER

Identifier Source: secondary_id

18132

Identifier Type: -

Identifier Source: org_study_id