Normal Healthy Subject Population
Conditions
Brief summary
The purpose of this study is to compare Prilosec OTC® and Zegerid® in their effects on gastric acid suppression.
Interventions
DRUGZegerid®
capsule(20 mg omeprazole/sodium bicarbonate), single dose
DRUGPrilosec OTC®
Omeprazole-magnesium 20.6 mg, tablet, single dose
Sponsors
Procter and Gamble
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
SINGLE (Investigator)
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 significant GI disease * Any significant medical illness * History of hypersensitivity, allergy or intolerance to omeprazole 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 |
|---|---|---|
| The Mean Percent Time Gastric pH > 4.0 on Day 1 | continuously over a 24 hour period | In this study, there was evidence of gastric pH probe failure and a high incidence of biologically improbable pH measurements (sustained pH \< 1.0) that bring the validity of the results into question. The results of this study are, therefore, inconclusive. |
Countries
United States
Participant flow
Recruitment details
The study period of this study was November 25 to December 21, 2008
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants |
| Age, Continuous | 26.4 years STANDARD_DEVIATION 4.47 |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 22 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
The Mean Percent Time Gastric pH > 4.0 on Day 1
In this study, there was evidence of gastric pH probe failure and a high incidence of biologically improbable pH measurements (sustained pH \< 1.0) that bring the validity of the results into question. The results of this study are, therefore, inconclusive.
Time frame: continuously over a 24 hour period
Population: Zeros are entered because the data are corrupted for 2 reasons: probe calibration failure rate was \~10x higher than historically documented, and the probes that calibrated had a high incidence of prolonged pH \< 1.0 (highly physiologically improbable). This calls into question the credibility and interpretability of all the pH data.