Randomized, Placebo-Controlled, Crossover Pharmacodynamic Study Comparing the Effects of Two Different Forms of Omeprazole
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Bayer
- Enrollment
- 30
- Primary Endpoint
- Percent Time With Intragastric pH>4 During the First 4 Hours Following Administration on Day 4 of Treatment
Study Overview
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:
- 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
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Placebo
Inert substance
Intervention: Placebo (Other)
Prilosec OTC™ tablets containing 20 mg-equivalent omeprazole
20.6 mg omeprazole-magnesium complex.
Intervention: Prilosec OTC™ Tablets (Drug)
Zegerid OTC Capsules
20 mg omeprazole and 1100 mg sodium bicarbonate
Intervention: Zegerid (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported