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The purpose of this study is to compare Prilosec OTC® and Zegerid® in their effects on gastric acid suppression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Zegerid® |
|
| 2 | Experimental | Prilosec OTC® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zegerid® | Drug | capsule(20 mg omeprazole/sodium bicarbonate), single dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | continuously over a 24 hour period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John McRorie, PhD, FACG, AGAF | Procter and Gamble | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Oklahoma City | Oklahoma | 73104 | United States |
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The study period of this study was November 25 to December 21, 2008
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| ID | Title | Description |
|---|---|---|
| FG000 | Zegerid® Then Prilosec OTC® | Zegerid® (20 mg omeprazole/sodium bicarbonate) then Prilosec OTC® (20.6 mg omeprazole magnesium) |
| FG001 | Prilosec OTC® Then Zegerid® | Prilosec OTC® (omeprazole magnesium 20.6 mg) then Zegerid® (20 mg omeprazole/sodium bicarbonate) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
| |||||||||||||
| Second Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Feb 2010 | continuously over a 24 hour period |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Zegerid® Then Prilosec OTC® | Zegerid® (20 mg omeprazole/sodium bicarbonate) then Prilosec OTC® (20.6 mg omeprazole magnesium) |
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Results of this study were uninterpretable as noted in the Analysis Population Description.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Mcrorie, PhD, FACG, AGAF | The Procter & Gamble Company | 513-622-1423 | mcrorie.jw@pg.com |
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| ID | Term |
|---|---|
| C494109 | omeprazole, sodium bicarbonate drug combination |
| D009853 | Omeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Prilosec OTC® |
| Drug |
Omeprazole-magnesium 20.6 mg, tablet, single dose |
|
| NOT COMPLETED |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | The study was a cross-over study with 30 subjects receiving each treatment; therefore, baseline characteristics are identical for each treatment. | Number | participants |
|
| OG001 |
| Prilosec OTC® Then Zegerid® |
Prilosec OTC® (omeprazole magnesium 20.6 mg) then Zegerid® (20 mg omeprazole/sodium bicarbonate) |
|
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Prilosec OTC® Then Zegerid® | Prilosec OTC® (omeprazole magnesium 20.6 mg) then Zegerid® (20 mg omeprazole/sodium bicarbonate) | 0 | 30 | 0 | 30 |
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| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |