Pharmacodynamic Study Comparing the Effects of Two Different Forms of Omeprazole (P07812) (COMPLETED)
- Conditions
- Intragastric Acidity
- Interventions
- Registration Number
- NCT01077076
- Lead Sponsor
- Bayer
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- Male or non-lactating, non-pregnant female subjects who are 18-65 years of age.
- Physical examination findings within normal limits for age.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Zegerid OTC Capsules Zegerid 20 mg omeprazole and 1100 mg sodium bicarbonate Prilosec OTC™ tablets containing 20 mg-equivalent omeprazole Prilosec OTC™ Tablets 20.6 mg omeprazole-magnesium complex. Placebo Placebo Inert substance
- Primary Outcome Measures
Name Time Method Percent Time With Intragastric pH>4 During the First 4 Hours Following Administration on Day 4 of Treatment 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 Outcome Measures
Name Time Method