Phase 3
Completed N=30
Pharmacodynamic Study Comparing the Effects of Two Different Forms of Omeprazole (P07812) (COMPLETED)
Intragastric Acidity
Source: ClinicalTrials.gov NCT01077076 ↗
Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Apr 2010
Primary outcomePrimary: Percent Time With Intragastric pH>4 During the First 4 Hours Following Administration on Day 4 of Treatment — 53.265; 46.933; 17.215 Percentage of Time
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Time With Intragastric pH>4 During the First 4 Hours Following Administration on Day 4 of Treatment |
53.265; 46.933; 17.215 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01077076). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.