Gastric Acid, Human Experimentation
Conditions
Brief summary
Open-label randomized crossover design studies. 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. The other 30 participants will receive a single administration of sodium bicarbonate.
Detailed description
Enrolled participants were divided into 2 groups, with 30 participants in each group. Group 1: This group was randomized into a 2-way crossover design with an added third period. These participants received single administrations (day 1 dosing only) of Zegerid Powder for Oral Suspension, and Prilosec OTC (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. Following completion of the 2-way crossover study, and a subsequent washout period (minimum of 2 weeks), all participants then received a single administration of sodium bicarbonate (at same dose as contained in Zegerid Powder for Oral Suspension) in Period 3. This group underwent a 24-hour intragastric pH study on each of the 3 dosing occasions. Group 2: This group was randomized into a 2-way crossover design in which they received 7 days administration of Zegerid Powder for Oral Suspension 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 also underwent 24-hour intragastric pH recordings on the days on 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 and Zegerid Powder for Oral Suspension on change in intragastric pH during the subsequent 24-hour period following the first dose.
Interventions
Omeprazole/sodium bicarbonate. Single dose per day for either 1 or 7 days.
Omeprazole 20 mg tablet. Single dose per day for either 1 or 7 days.
DRUGsodium bicarbonate
Sodium bicarbonate. Single dose.
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. PH measures how acidic or basic a substance is. 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 randomized to either 1-Day or 7-Day Dosing in this crossover study (participants in both groups received 1 treatment \[Zegerid or Prilosec\], followed by washout period, followed by the other treatment \[Prilosec or Zegerid\]). Participants in the 1-day dosing group also received sodium bicarbonate after a washout period.
Participants by arm
| Arm | Count |
|---|---|
| Entire Study Population | 60 |
| Total | 60 |
Baseline characteristics
| Characteristic | Entire Study Population |
|---|---|
| Age, Continuous | 25.3 years STANDARD_DEVIATION 4.37 |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 30 | 2 / 30 | 0 / 30 | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 | 0 / 30 | 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. PH measures how acidic or basic a substance is. 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
Population: 25 participants in each arm had good quality tracings and were included in the efficacy analysis.
| 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 | 3.250 pH scale | Full Range 1.3 |
| Zegerid | Change From Baseline in Median 24-hour Intragastric pH on the 7th Day of Drug Administration | Change from Baseline in PH | 2.180 pH scale | Full Range 1.32 |
| Prilosec | Change From Baseline in Median 24-hour Intragastric pH on the 7th Day of Drug Administration | Day 7 Score | 4.160 pH scale | Full Range 1.26 |
| Prilosec | Change From Baseline in Median 24-hour Intragastric pH on the 7th Day of Drug Administration | Change from Baseline in PH | 2.900 pH scale | Full Range 1.244 |