Intragastric Acidity
Conditions
Keywords
Gastric Acid, Human Experimentation
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.
Interventions
DRUGZegerid
Zegerid taken once daily for 11 days.
DRUGPrilosec OTC™ Tablets
Prilosec OTC™ Tablets taken once daily for 11 days.
OTHERPlacebo
Placebo taken once daily for 11 days.
Sponsors
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Entire Study Population | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| First Intervention | Withdrawal by Subject | 1 | 0 | 0 | 0 | 0 | 0 |
| Third Intervention | Death in the participant's family | 0 | 0 | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Entire Study Population |
|---|---|
| Age, Continuous | 27.8 years STANDARD_DEVIATION 7.25 |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 30 | 2 / 29 | 0 / 29 |
| serious Total, serious adverse events | 0 / 30 | 0 / 29 | 0 / 29 |
Outcome results
Primary
Percent Time With Intragastric pH>4 During the First 4 Hours Following Administration on Day 4 of Treatment
Early effectiveness of treatment is evaluated as the percent time with intragastric pH\>4 during the first 4 hours following administration of respective treatments
Time frame: 4 hours after dose on Day 4
Population: Pharmacodynamic-Evaluable Population: All participants who presented valid data from all three study periods.~One participant was dropped from the Pharmacodynamic-Evaluable Population in the Prilosec OTC Tablets group because of invalid pH tracings at Day 4. Therefore, the number of participants included at Day 4 in this group was 26.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Zegerid OTC Capsules | Percent Time With Intragastric pH>4 During the First 4 Hours Following Administration on Day 4 of Treatment | 53.265 Percentage of Time | Standard Deviation 27.588 |
| Prilosec OTC Tablets | Percent Time With Intragastric pH>4 During the First 4 Hours Following Administration on Day 4 of Treatment | 46.933 Percentage of Time | Standard Deviation 21.885 |
| Placebo Capsules | Percent Time With Intragastric pH>4 During the First 4 Hours Following Administration on Day 4 of Treatment | 17.215 Percentage of Time | Standard Deviation 15.432 |