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| ID | Type | Description | Link |
|---|---|---|---|
| CL2007-17 | |||
| P07813 | Other Identifier | Merck |
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| Name | Class |
|---|---|
| Bausch Health Americas, Inc. | INDUSTRY |
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Open-label randomized crossover design studies. 60 participants will be evaluated on Day 1 to compare effects on stomach acid; 30 participants will continue treatment for 7 days and will have repeat evaluations at Day 7. The other 30 participants will receive a single administration of sodium bicarbonate.
Enrolled participants were divided into 2 groups, with 30 participants in each group.
Group 1: This group was randomized into a 2-way crossover design with an added third period. These participants received single administrations (day 1 dosing only) of Zegerid Powder for Oral Suspension, and Prilosec OTC (both at a 20 mg omeprazole dose), in a 2-way randomized order, with a minimum of a 2-week washout period between treatment legs. Following completion of the 2-way crossover study, and a subsequent washout period (minimum of 2 weeks), all participants then received a single administration of sodium bicarbonate (at same dose as contained in Zegerid Powder for Oral Suspension) in Period 3. This group underwent a 24-hour intragastric pH study on each of the 3 dosing occasions.
Group 2: This group was randomized into a 2-way crossover design in which they received 7 days administration of Zegerid Powder for Oral Suspension and Prilosec OTC tablets, respectively. As with the prior group, there was a minimum of a 2-week washout period between treatment legs. Participants assigned to this treatment group also underwent 24-hour intragastric pH recordings on the days on which they received their 1st and last (7th) dose of the two treatment drugs.
In addition to the above detailed procedures, all participants (both groups) underwent a 24-hour baseline intragastric pH study prior to starting their randomized treatments. This study design enabled all 60 participants to be evaluated for effects of the first dose of Prilosec OTC and Zegerid Powder for Oral Suspension on change in intragastric pH during the subsequent 24-hour period following the first dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Dose Zegerid for 1 or 7 days | Experimental | Omeprazole 20 mg/Sodium Bicarbonate 1680 mg Powder for Oral Suspension |
|
| Single Dose Prilosec 1 or 7 days | Active Comparator | Omeprazole magnesium 20 mg over-the-counter (OTC) Tablet |
|
| Sodium Bicarbonate | Active Comparator | Sodium Bicarbonate 1680 mg Oral Suspension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omeprazole/sodium bicarbonate | Drug | Omeprazole/sodium bicarbonate. Single dose per day for either 1 or 7 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Median 24-hour Intragastric pH on the 7th Day of Drug Administration | The change from Baseline in median pH was calculated as: median pH on Day 7 minus median pH at Baseline. PH measures how acidic or basic a substance is. The pH scale ranges from 0 to 14. A pH of 7 is neutral. A pH less than 7 is acidic. A pH greater than 7 is basic. | Baseline and 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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60 participants were randomized to either 1-Day or 7-Day Dosing in this crossover study (participants in both groups received 1 treatment [Zegerid or Prilosec], followed by washout period, followed by the other treatment [Prilosec or Zegerid]). Participants in the 1-day dosing group also received sodium bicarbonate after a washout period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Zegerid, Prilosec, Sodium Bicarbonate | Participants received Zegerid Oral Suspension (omeprazole 20 mg and sodium bicarbonate 1680 mg) in the first intervention, Prilosec over-the-counter (OTC) Tablets (omeprazole 20 mg) in the second intervention (after washout period), and Sodium Bicarbonate Oral Suspension (sodium bicarbonate 1680 mg) in the third intervention (after washout period) |
| FG001 | Prilosec, Zegerid, Sodium Bicarbonate | Participants received Prilosec OTC Tablets (omeprazole 20 mg) in the first intervention, Zegerid Oral Suspension (omeprazole 20 mg and sodium bicarbonate 1680 mg) in the second intervention (after washout period), and Sodium Bicarbonate Oral Suspension (sodium bicarbonate 1680 mg) in the third intervention (after washout period) |
| FG002 | Zegerid, Prilosec | Participants received Zegerid Oral Suspension (omeprazole 20 mg and sodium bicarbonate 1680 mg) in the first intervention and Prilosec OTC Tablets (omeprazole 20 mg) in the second intervention (after washout period) |
| FG003 | Prilosec, Zegerid | Participants received Prilosec OTC Tablets (omeprazole 20 mg) in the first intervention and Zegerid Oral Suspension (omeprazole 20 mg and sodium bicarbonate 1680 mg) in the second intervention (after 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 |
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| 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 | Change From Baseline in Median 24-hour Intragastric pH on the 7th Day of Drug Administration | The change from Baseline in median pH was calculated as: median pH on Day 7 minus median pH at Baseline. PH measures how acidic or basic a substance is. The pH scale ranges from 0 to 14. A pH of 7 is neutral. A pH less than 7 is acidic. A pH greater than 7 is basic. | 25 participants in each arm had good quality tracings and were included in the efficacy analysis. | Posted | Median | Full Range | pH scale | Baseline and 7 days |
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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 (7-Day Dosing) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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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 |
| D017693 | Sodium Bicarbonate |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| omeprazole magnesium | Drug | Omeprazole 20 mg tablet. Single dose per day for either 1 or 7 days. |
|
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| sodium bicarbonate | Drug | Sodium bicarbonate. Single dose. |
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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 |
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| Sex: Female, Male | Count of Participants | Participants |
|
Participants in the 7-Day Dosing group. Measurements taken on the 7th day of Prilosec administration.
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|
| 0 |
| 30 |
| 2 |
| 30 |
| EG001 | Prilosec (7-Day Dosing) | 0 | 30 | 2 | 30 |
| EG002 | Sodium Bicarbonate (1-Day Dosing) | Following completion of the 1-day dosing 2-way crossover study, and a subsequent washout period (minimum of 2 weeks), all participants then received a single administration of sodium bicarbonate 1680 mg. | 0 | 30 | 0 | 30 |
| EG003 | Zegerid (1-Day Dosing) | 0 | 30 | 0 | 30 |
| EG004 | Prilosec (1-Day Dosing) | 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 |
| D001639 | Bicarbonates |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |