Gastric Acid, Human Experimentation
Conditions
Brief summary
Open-label randomized crossover design study. 60 participants will be evaluated on Day 1 to compare effects on stomach acid; 30 participants will continue treatment for 7 days and will have repeat evaluations at Day 7.
Detailed description
Enrolled participants were divided into 2 groups, with 30 participants in each group. Group 1: This group was randomized into a single-dose, 2-way crossover design. These participants received single administrations (day 1 dosing only) of Zegerid OTC Capsules, and Prilosec OTC Tablets (both at a 20 mg omeprazole dose), in a 2-way randomized order, with a minimum of a 2-week washout period between treatment legs. This group underwent a 24-hour intragastric pH study on each of the 2 dosing occasions. Group 2: This group was randomized into a 2-way crossover design in which they received 7 days administration of Zegerid OTC Capsules and Prilosec OTC Tablets, respectively. As with the prior group, there was a minimum of a 2-week washout period between treatment legs. Participants assigned to this treatment group underwent 24-hour intragastric pH recordings on the days which they received their 1st and last (7th) dose of the two treatment drugs. In addition to the above detailed procedures, all participants (both groups) underwent a 24-hour baseline intragastric pH study prior to starting their randomized treatments. This study design enabled all 60 participants to be evaluated for effects of the first dose of Prilosec OTC Tablets and Zegerid OTC Capsules on change in intragastric pH during the subsequent 24-hour period following the first dose.
Interventions
Single dose of omeprazole/sodium bicarbonate per day for either 1 or 7 days.
DRUGomeprazole magnesium (20 mg equivalent)
Single dose of omeprazole magnesium per day for either 1 or 7 days.
Sponsors
Bausch Health Americas, Inc.
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Normal subjects who are 18-65 years of age. * Non-childbearing potential females or those using birth control.
Exclusion criteria
* History of hypersensitivity, allergy or intolerance to omeprazole or other proton pump inhibitors * History of significant gastrointestinal disease * Any significant medical illness * Gastrointestinal disorder or surgery leading to impaired drug absorption * Currently using gastrointestinal medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Median 24-hour Intragastric pH on the 7th Day of Drug Administration | Baseline and 7 days | The change from Baseline in median pH was calculated as: median pH on Day 7 minus median pH at Baseline. The pH scale ranges from 0 to 14. A pH of 7 is neutral. A pH less than 7 is acidic. A pH greater than 7 is basic. |
Participant flow
Pre-assignment details
60 participants were enrolled: 30 participants were randomized to 1-Day Dosing and 30 participants were randomized to 7-Day Dosing. This was a crossover study, ie, participants in both groups received one treatment \[Zegerid or Prilosec\], followed by a 2-week washout period, followed by the other treatment \[Prilosec or Zegerid\].
Participants by arm
| Arm | Count |
|---|---|
| Entire Study Population | 60 |
| Total | 60 |
Baseline characteristics
| Characteristic | Entire Study Population |
|---|---|
| Age, Continuous | 26.6 years STANDARD_DEVIATION 8.04 |
| Region of Enrollment United States | 60 participants |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Change From Baseline in Median 24-hour Intragastric pH on the 7th Day of Drug Administration
The change from Baseline in median pH was calculated as: median pH on Day 7 minus median pH at Baseline. The pH scale ranges from 0 to 14. A pH of 7 is neutral. A pH less than 7 is acidic. A pH greater than 7 is basic.
Time frame: Baseline and 7 days
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Zegerid | Change From Baseline in Median 24-hour Intragastric pH on the 7th Day of Drug Administration | Day 7 Score | 4.575 pH scale | Full Range 1.349 |
| Zegerid | Change From Baseline in Median 24-hour Intragastric pH on the 7th Day of Drug Administration | Change from Baseline in pH | 3.165 pH scale | Full Range 1.36 |
| Prilosec | Change From Baseline in Median 24-hour Intragastric pH on the 7th Day of Drug Administration | Day 7 Score | 3.980 pH scale | Full Range 1.433 |
| Prilosec | Change From Baseline in Median 24-hour Intragastric pH on the 7th Day of Drug Administration | Change from Baseline in pH | 2.550 pH scale | Full Range 1.478 |