Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CL2008-02 | |||
| P07814 | Other Identifier | Merck |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Bausch Health Americas, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Open-label randomized crossover design study. 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.
Enrolled participants were divided into 2 groups, with 30 participants in each group.
Group 1: This group was randomized into a single-dose, 2-way crossover design. These participants received single administrations (day 1 dosing only) of Zegerid OTC Capsules, and Prilosec OTC Tablets (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. This group underwent a 24-hour intragastric pH study on each of the 2 dosing occasions.
Group 2: This group was randomized into a 2-way crossover design in which they received 7 days administration of Zegerid OTC Capsules 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 underwent 24-hour intragastric pH recordings on the days 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 Tablets and Zegerid OTC Capsules on change in intragastric pH during the subsequent 24-hour period following the first dose.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zegerid | Experimental | Omeprazole 20 mg /sodium bicarbonate 1100 mg over-the-counter (OTC) Capsule |
|
| Prilosec | Active Comparator | Omeprazole magnesium 20 mg OTC tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omeprazole/sodium bicarbonate | Drug | Single dose of omeprazole/sodium bicarbonate 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. 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
60 participants were enrolled: 30 participants were randomized to 1-Day Dosing and 30 participants were randomized to 7-Day Dosing. This was a crossover study, ie, participants in both groups received one treatment [Zegerid or Prilosec], followed by a 2-week washout period, followed by the other treatment [Prilosec or Zegerid].
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Zegerid First, Then Prilosec (1- Day Dosing) | Participants received Zegerid Over-the-counter (OTC) Capsules (omeprazole 20 mg and sodium bicarbonate 1100 mg) in the first intervention and Prilosec OTC Tablets (omeprazole 20 mg) in the second intervention (after washout period) |
| FG001 | Prilosec First, Then Zegerid (1-Day Dosing) | Participants received Prilosec OTC Tablets (omeprazole 20 mg) in the first intervention and Zegerid OTC Capsules (omeprazole 20 mg and sodium bicarbonate 1100 mg) in the second intervention (after washout period) |
| FG002 | Zegerid First, Then Prilosec ( 7-Day Dosing) | Participants received Zegerid OTC Capsules (omeprazole 20 mg and sodium bicarbonate 1100 mg) in the first intervention and Prilosec OTC Tablets (omeprazole 20 mg) in the second intervention (after washout period) |
| FG003 | Prilosec First, Then Zegerid (7-Day Dosing) | Participants received Prilosec OTC Tablets (omeprazole 20 mg) in the first intervention and Zegerid OTC Capsules (omeprazole 20 mg and sodium bicarbonate 1100 mg) in the second intervention (after washout period) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
| |||||||||||||
| Washout Period of 14 Days |
| |||||||||||||
| Second Intervention |
|
Not provided
Not provided
| 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 | 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. 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. | Posted | Median | Full Range | pH scale | Baseline and 7 days |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Zegerid | Subjects who received a single dose of Zegerid per day for either 1 or 7 days. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
Not provided
| ID | Term |
|---|---|
| C494109 | omeprazole, sodium bicarbonate drug combination |
| D009853 | Omeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| omeprazole magnesium (20 mg equivalent) | Drug | Single dose of omeprazole magnesium per day for either 1 or 7 days. |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Prilosec | Subjects who received a single dose of Prilosec per day for either 1 or 7 days. | 0 | 30 | 0 | 30 |
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 |