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| ID | Type | Description | Link |
|---|---|---|---|
| P07812 | Other Identifier | Merck |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zegerid OTC Capsules | Experimental | 20 mg omeprazole and 1100 mg sodium bicarbonate |
|
| Prilosec OTC™ tablets containing 20 mg-equivalent omeprazole | Active Comparator | 20.6 mg omeprazole-magnesium complex. |
|
| Placebo | Placebo Comparator | Inert substance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zegerid | Drug | Zegerid taken once daily for 11 days. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4 hours after dose on Day 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | Zegerid/Prilosec/Placebo | Participants received Zegerid over-the-counter (OTC) Capsules (20 mg omeprazole and 1100 mg sodium bicarbonate) in the first intervention, Prilosec OTC Tablets (20 mg-equivalent omeprazole) in the second intervention (after the washout period), and Placebo Capsules in the third intervention (after the washout period). |
| FG001 | Zegerid/Placebo/Prilosec | Participants received Zegerid OTC Capsules (20 mg omeprazole and 1100 mg sodium bicarbonate) in the first intervention, Placebo Capsules in the second intervention (after the washout period), and Prilosec OTC Tablets (20 mg-equivalent omeprazole) in the third intervention (after the washout period). |
| FG002 | Prilosec/Zegerid/Placebo | Participants received Prilosec OTC Tablets (20 mg-equivalent omeprazole) in the first intervention, Zegerid OTC Capsules (20 mg omeprazole and 1100 mg sodium bicarbonate) in the second intervention (after the washout period), and Placebo Capsules in the third intervention (after the washout period). |
| FG003 | Prilosec/Placebo/Zegerid | Participants received Prilosec OTC Tablets (20 mg-equivalent omeprazole) in the first intervention, Placebo Capsules in the second intervention (after the washout period), and Zegerid OTC Capsules (20 mg omeprazole and 1100 mg sodium bicarbonate) in the third intervention (after the washout period). |
| FG004 | Placebo/Zegerid/Prilosec | Participants received Placebo Capsules in the first intervention, Zegerid OTC Capsules (20 mg omeprazole and 1100 mg sodium bicarbonate) in the second intervention (after the washout period), and Prilosec OTC Tablets (20 mg-equivalent omeprazole) in the third intervention (after the washout period). |
| FG005 | Placebo/Prilosec/Zegerid | Participants received Placebo Capsules in the first intervention, Prilosec OTC Tablets (20 mg-equivalent omeprazole) in the second intervention (after the washout period), and Zegerid OTC Capsules (20 mg omeprazole and 1100 mg sodium bicarbonate) in the third intervention (after the washout period). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
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| Washout Period of 2 Weeks |
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| Second Intervention |
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| Washout Period of 2 Weeks |
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| Third Intervention |
|
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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, Continuous | Mean |
| 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 | 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 | 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. | Posted | Mean | Standard Deviation | Percentage of Time | 4 hours after dose on Day 4 |
|
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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 OTC Capsules | 20 mg omeprazole and 1100 mg sodium bicarbonate |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper Respiratory Tract Infection | Infections and infestations |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.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™ Tablets |
| Drug |
Prilosec OTC™ Tablets taken once daily for 11 days. |
|
| Placebo | Other | Placebo taken once daily for 11 days. |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Prilosec OTC Tablets |
20 mg-equivalent omeprazole |
| OG002 | Placebo Capsules |
|
|
| 0 |
| 30 |
| 2 |
| 30 |
| EG001 | Prilosec OTC Tablets | 20 mg-equivalent omeprazole | 0 | 29 | 2 | 29 |
| EG002 | Placebo Capsules | 0 | 29 | 0 | 29 |
Schering-Plough HealthCare Products, Inc. reserves all publication and presentation rights.
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |