Healthy
Conditions
Keywords
Normal Healthy Subject Population
Brief summary
The objective of this study is to compare Prilosec OTC® to Prevacid® for gastric acid suppression.
Interventions
DRUGPrilosec OTC (omeprazole-magnesium)
Prilosec OTC (omeprazole-magnesium 20.6 mg) tablet to be taken with a glass of water prior to breakfast
DRUGPrevacid
Prevacid (15 mg lansoprazole) capsule to be taken with a glass of water prior to breakfast
Sponsors
Procter and Gamble
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* normal subjects who are age 18-65 * generally healthy * non-childbearing potential females or those using birth control
Exclusion criteria
* history of significant GI disease * any significant medical illness * history of hypersensitivity, allergy or intolerance to omeprazole, lansoprazole or other proton pump inhibitors * currently using GI medications * GI disorder or surgery leading to impaired drug absorption
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Percent Time That Gastric pH > 4.0 on Day 5 | 24 hours | for 24 hours starting Day 5 for each period |
Countries
United States
Participant flow
Recruitment details
This single-center, double-blind, randomized, 2-treatment, 3-period cross-over study conducted in forty healthy adult subjects living in the vicinity of the site.
Participants by arm
| Arm | Count |
|---|---|
| Entire Study Population | 40 |
| Total | 40 |
Baseline characteristics
| Characteristic | Entire Study Population |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 40 Participants |
| Age Continuous | 28 years STANDARD_DEVIATION 6.65 |
| Region of Enrollment United States | 40 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 40 | 2 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
Primary
Mean Percent Time That Gastric pH > 4.0 on Day 5
for 24 hours starting Day 5 for each period
Time frame: 24 hours
Population: This study was a three period, crossover study of 40 subjects entering either treatment sequence ABB or BAA; consequently each subject in the study participated in three periods over which each subject would eventually receive both Prilosec OTC and Prevacid
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prilosec OTC Then Prevacid Then Prevacid | Mean Percent Time That Gastric pH > 4.0 on Day 5 | 36.8 percent time gastric pH exceeds 4.0 | Standard Error 3.45 |
| Prevacid Then Prilosec OTC Then Prilosec OTC | Mean Percent Time That Gastric pH > 4.0 on Day 5 | 45.7 percent time gastric pH exceeds 4.0 | Standard Error 3.45 |
Comparison: This study enrolled 40 subjects in order to complete a target of at least 30 evaluable subjects. For the purpose of determination of sample size, it was assumed that at least 30 subjects would have complete data for all 3 treatment periods. Assuming the true mean difference in % time that gastric pH \> 4.0 between Prilosec OTC and Prevacid was at least 6.5, it was estimated that there would be at least 80% power to detect a treatment difference in 2-sided testing at the 5% significance level.p-value: <0.0001Mixed Models Analysis