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The objective of this study is to compare Prilosec OTC® to Prevacid® for gastric acid suppression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Prilosec OTC |
|
| B | Active Comparator | Prevacid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prilosec OTC (omeprazole-magnesium) | Drug | Prilosec OTC (omeprazole-magnesium 20.6 mg) tablet to be taken with a glass of water prior to breakfast |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percent Time That Gastric pH > 4.0 on Day 5 | for 24 hours starting Day 5 for each period | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Simon H Magowan, MD | Procter and Gamble | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Oklahoma City | Oklahoma | 73104 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Prilosec OTC Then Prevacid Then Prevacid | This study was a 3-period crossover (ABB, BAA). Prilosec OTC (20.6 mg omeprazole magnesium tablet) and Prevacid (15 mg lansoprazole capsule) were administered daily before breakfast. |
| FG001 | Prevacid Then Prilosec OTC Then Prilosec OTC | This study was a 3-period crossover (ABB, BAA). Prilosec OTC (20.6 mg omeprazole magnesium tablet) and Prevacid (15 mg lansoprazole capsule) were administered daily before breakfast. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1: 5 Days Then 10 Day Washout |
| |||||||||||||
| Period 2: 5 Days Then 10 Day Washout |
| |||||||||||||
| Period 3: 5 Days |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population |
| 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 | Mean Percent Time That Gastric pH > 4.0 on Day 5 | for 24 hours starting Day 5 for each period | 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 | Posted | Mean | Standard Error | percent time gastric pH exceeds 4.0 | 24 hours |
|
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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 | Prilosec OTC Then Prevacid Then Prevacid | This study was a 3-period crossover (ABB, BAA). Prilosec OTC (20.6 mg omeprazole magnesium tablet) and Prevacid (15 mg lansoprazole capsule) were administered daily before breakfast. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
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| 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 |
|---|---|
| D009853 | Omeprazole |
| D064747 | Lansoprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Prevacid | Drug | Prevacid (15 mg lansoprazole) capsule to be taken with a glass of water prior to breakfast |
|
| NOT COMPLETED |
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| NOT COMPLETED |
|
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
This study was a 3-period crossover (ABB, BAA). Prilosec OTC (20.6 mg omeprazole magnesium tablet) and Prevacid (15 mg lansoprazole capsule) were administered daily before breakfast. |
|
|
|
| 0 |
| 40 |
| 1 |
| 40 |
| EG001 | Prevacid Then Prilosec OTC Then Prilosec OTC | This study was a 3-period crossover (ABB, BAA). Prilosec OTC (20.6 mg omeprazole magnesium tablet) and Prevacid (15 mg lansoprazole capsule) were administered daily before breakfast. | 0 | 40 | 2 | 40 |
| Headache | Nervous system disorders | COSTART | Non-systematic Assessment |
|
| Skin Disease | Skin and subcutaneous tissue disorders | COSTART | Non-systematic Assessment |
|
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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 |