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

Overview

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.

Full Title of Study: “Randomized, Placebo-Controlled, Crossover Pharmacodynamic Study Comparing the Effects of Two Different Forms of Omeprazole”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2009

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.

Interventions

  • Drug: Zegerid
    • Zegerid taken once daily for 11 days.
  • Drug: Prilosec OTC™ Tablets
    • Prilosec OTC™ Tablets taken once daily for 11 days.
  • Other: Placebo
    • Placebo taken once daily for 11 days.

Arms, Groups and Cohorts

  • Experimental: Zegerid OTC Capsules
    • 20 mg omeprazole and 1100 mg sodium bicarbonate
  • Active Comparator: Prilosec OTC™ tablets containing 20 mg-equivalent omeprazole
    • 20.6 mg omeprazole-magnesium complex.
  • Placebo Comparator: Placebo
    • Inert substance

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Bayer
  • Provider of Information About this Clinical Study
    • Sponsor

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.