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| ID | Type | Description | Link |
|---|---|---|---|
| CL2008-18 | |||
| P07815 | Other Identifier | Merck |
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This study will determine differences between Proton Pump Inhibitors (PPI) formulations relative to their effects on gastric acidity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zegerid | Experimental | Participants receiving Zegerid (omeprazole/sodium bicarbonate) in Periods 1, 2 or 3. All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order. All participants also took approximately 2 oz of water with their medication. |
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| Prevacid® | Active Comparator | Participants receiving Prevacid® (lansoprazole) in Periods 1, 2 or 3. All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order. All participants also took approximately 2 oz of water with their medication. |
|
| No treatment | No Intervention | Participants receiving No treatment in Periods 1, 2 or 3. All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order. All participants took approximately 2 oz of water once daily for 7 days. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zegerid | Drug | Zegerid (20 mg omeprazole/ 1100 mg sodium bicarbonate) taken with approximately 2 oz of water once daily for 7 days. |
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| Measure | Description | Time Frame |
|---|---|---|
| Achievement of Sustained Difference in Inhibition of Intragastric Acidity Based on Median pH Values Between the Two Active Study Treatments at Steady-state on Day 7 | Median intragastric pH scores were collected at 5 minute intervals after treatment dose. The achievement of sustained difference was the earliest time for which a statistically significant difference was observed in the median intragastric pH scores for 3 consecutive 5-minute intervals. The earliest 3 time points for which a statistically significant difference was observed between the median intragastric pH values for the two active treatments for three consecutive 5-minute intervals are shown here. | Treatment dose to 4-hr post-dose on Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Achievement of Sustained Difference in Inhibition of Intragastric Acidity Based on Median pH Values Between the Two Active Study Treatments at Steady-state on Day 1 | Median intragastric pH scores were collected at 5 minute intervals after treatment dose. The achievement of sustained difference was the earliest time for which a statistically significant difference was observed in the median intragastric pH scores for 3 consecutive 5-minute intervals. The earliest 3 time points for which a statistically significant difference was observed between the median intragastric pH values for the two active treatments for three consecutive 5-minute intervals are shown here. |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | Zegerid-Prevacid®-No Treatment | Participants received Zegerid in Period 1, Prevacid® in Period 2 and No treatment in Period 3. |
| FG001 | Zegerid-No Treatment-Prevacid® | Participants received Zegerid in Period 1, No treatment in Period 2 and Prevacid® in Period 3 |
| FG002 | Prevacid®-Zegerid-No Treatment | Participants received Prevacid® in Period 1, Zegerid in Period 2 and No treatment in Period 3 |
| FG003 | Prevacid®-No Treatment-Zegerid | Participants received Prevacid® in Period 1, No treatment in Period 2 and Zegerid in Period 3 |
| FG004 | No Treatment-Zegerid-Prevacid® | Participants received No treatment in Period 1, Zegerid in Period 2 and Prevacid® in Period 3 |
| FG005 | No Treatment-Prevacid®-Zegerid | Participants received No treatment in Period 1, Prevacid® in Period 2 and Zegerid in Period 3 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
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| Period 3 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study |
| 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 | Achievement of Sustained Difference in Inhibition of Intragastric Acidity Based on Median pH Values Between the Two Active Study Treatments at Steady-state on Day 7 | Median intragastric pH scores were collected at 5 minute intervals after treatment dose. The achievement of sustained difference was the earliest time for which a statistically significant difference was observed in the median intragastric pH scores for 3 consecutive 5-minute intervals. The earliest 3 time points for which a statistically significant difference was observed between the median intragastric pH values for the two active treatments for three consecutive 5-minute intervals are shown here. | Participants who received at least one dose of study treatment, and did not have missing values. | Posted | Median | Full Range | pH | Treatment dose to 4-hr post-dose on Day 7 |
|
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Adverse events were collected for all participants who received at least one dose of study treatment.
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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 | Participants receiving Zegerid in Periods 1, 2 or 3. All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDRA (10.1) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (10.1) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| C494109 | omeprazole, sodium bicarbonate drug combination |
| D009853 | Omeprazole |
| D017693 | Sodium Bicarbonate |
| 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) taken with approximately 2 oz of water once daily for 7 days. |
|
|
| Treatment dose to 4-hr post-dose on Day 1 |
| The Difference in the Onset of Action Based on Median pH Values Between the Two Active Treatments Compared to No Treatment on Day 1 and Day 7 | Median intragastric pH scores were collected at 5 minute intervals after treatment dose. The difference in the onset of action was the earliest 5 minute interval (from start of interval to end of interval) for which each active treatment presented a statistically significantly advantage over No treatment based on median pH values. The earliest 5 minute interval showing the difference in onset of action is reported here. | Treatment dose to 4-hr post-dose on Day 1 and Day 7 |
| Median Time to Achieve Intragastric pH > = 3.5 for a 10-Minute Period | The time required to achieve an intragastric pH ≥3.5 that is reached for 10 consecutive minutes after drug administration on the 1st and 7th days of dosing. | Treatment dose to 4-hr post-dose on Day 1 and Day 7 |
| Percentage Time Intragastric pH >4 During the First 4 Hours After Dosing on Day 7 | Treatment dose to 4 hours Post-dose on Day 7 |
| Median 24-hr Intragastric pH on Day 7 | The median intragastric pH values were recorded over a 24-hr period. | Treatment dose to 24-hour post-dose on Day 7 |
| Percentage of Time Intragastric is pH >4 Over 24-hour Period on Day 7 | Treatment dose to 24-hour post-dose on Day 7 |
| Percentage of Time Intragastric pH >3.5 Over 24-hour Period on Day 7 | Treatment dose to 24-hours post-dose on Day 7 |
| Number of Participants With Intragastric pH >4 for More Than 50% of the Time on Day 7 | Number of participants maintaining intragastric pH > 4 for at least 12 hrs at steady-state on Day 7 | Treatment dose to 24-hour post-dose on Day 7 |
| Number of Participants With Intragastric pH >3.5 for More Than 50% of the Time on Day 7 | Number of participants maintaining intragastric pH > 3.5 for at least 12 hrs at steady-state on Day 7 | Treatment dose to 24-hour post-dose on Day 7 |
| Percentage of Time Intragastric pH >4 Over the Nocturnal Period on Day 7 | Treatment dose to 24-hour post-dose on Day 7 |
| Time to Achieve Sustained Intragastric pH > 3.5 at Steady-state on Day 7 | The first time to sustain median pH > 3.5 for at least 3 successive 5-minute periods within the first 2 hours after dosing with Zegerid Capsules, and Prevacid Capsules, or No treatment on the 7th day of respective treatments. If this condition was not met for any time point within the first 2 hours following dosing, a score of 120 minutes was imputed. | Treatment dose to 2-hours post-dose on Day 7 |
| Time to Onset of Inhibition of Acid Secretion on Day 1 | The onset of inhibition of acid secretion was the first time to sustain median pH >3.5 for each of the twenty-four successive 5-minute periods. If this condition was not met for any time point within the first 4 hours following dosing, a score of 240 minutes was imputed. | Treatment dose to onset of event on Day 1 |
| Number of Participants Maintaining Intragastric pH > 4 for at Least 12 Hours on Day 1 | Treatment dose to 24-hr post-dose on Day 1 |
| Number of Participants Maintaining Intragastric pH > 3.5 for at Least 12 Hours on Day 1 | Treatment dose to 24-hr post-dose on Day 1 |
| Percentage of Time Intragastric pH >4 Over the Nocturnal Period on Day 1 | Treatment dose to 24-hour post-dose on Day 1 |
| Percentage of Time Intragastric pH >4 During the First 4 Hours on Day 1 | Treatment dose to 4-hours post-dose on Day 1 |
| Time to Achieve Sustained Advantage Over No Treatment During the First 4 Hours After Dosing | The earliest time during the first 4 hours after dosing that the median pH for the treatment is over 1 unit higher than that for the No treatment during the next three 5 minute intervals. (When this condition does not occur, the time to sustained advantage will be imputed as 4 hours.) | Treatment dose to event on Day 1 and Day 7 |
| Delay in completing study procedures |
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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 |
|
| OG001 | Prevacid® | Participants receiving Prevacid® in Periods 1, 2 or 3. All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order. |
|
|
|
| Secondary | Achievement of Sustained Difference in Inhibition of Intragastric Acidity Based on Median pH Values Between the Two Active Study Treatments at Steady-state on Day 1 | Median intragastric pH scores were collected at 5 minute intervals after treatment dose. The achievement of sustained difference was the earliest time for which a statistically significant difference was observed in the median intragastric pH scores for 3 consecutive 5-minute intervals. The earliest 3 time points for which a statistically significant difference was observed between the median intragastric pH values for the two active treatments for three consecutive 5-minute intervals are shown here. | Participants who received at least one dose of a study treatment, and presented valid data from all three study periods. | Posted | Median | Full Range | pH | Treatment dose to 4-hr post-dose on Day 1 |
|
|
|
|
| Secondary | The Difference in the Onset of Action Based on Median pH Values Between the Two Active Treatments Compared to No Treatment on Day 1 and Day 7 | Median intragastric pH scores were collected at 5 minute intervals after treatment dose. The difference in the onset of action was the earliest 5 minute interval (from start of interval to end of interval) for which each active treatment presented a statistically significantly advantage over No treatment based on median pH values. The earliest 5 minute interval showing the difference in onset of action is reported here. | Participants who received at least one dose of a study treatment, and presented valid data from all three study periods. | Posted | Median | Full Range | pH | Treatment dose to 4-hr post-dose on Day 1 and Day 7 |
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| Secondary | Median Time to Achieve Intragastric pH > = 3.5 for a 10-Minute Period | The time required to achieve an intragastric pH ≥3.5 that is reached for 10 consecutive minutes after drug administration on the 1st and 7th days of dosing. | Participants who received at least one dose of study treatment, and did not have missing values. | Posted | Median | Full Range | Minutes | Treatment dose to 4-hr post-dose on Day 1 and Day 7 |
|
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| Secondary | Percentage Time Intragastric pH >4 During the First 4 Hours After Dosing on Day 7 | Participants who received at least one dose of a study treatment, and presented valid data from all three study periods. | Posted | Median | Full Range | Percentage of time | Treatment dose to 4 hours Post-dose on Day 7 |
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| Secondary | Median 24-hr Intragastric pH on Day 7 | The median intragastric pH values were recorded over a 24-hr period. | Participants who received at least one dose of a study treatment, and presented valid data from all three study periods. | Posted | Median | Full Range | pH | Treatment dose to 24-hour post-dose on Day 7 |
|
|
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| Secondary | Percentage of Time Intragastric is pH >4 Over 24-hour Period on Day 7 | Participants who received at least one dose of a study treatment, and presented valid data from all three study periods. | Posted | Median | Full Range | Percentage of time | Treatment dose to 24-hour post-dose on Day 7 |
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|
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| Secondary | Percentage of Time Intragastric pH >3.5 Over 24-hour Period on Day 7 | Participants who received at least one dose of a study treatment, and presented valid data from all three study periods. | Posted | Median | Full Range | Percentage of Time | Treatment dose to 24-hours post-dose on Day 7 |
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|
|
| Secondary | Number of Participants With Intragastric pH >4 for More Than 50% of the Time on Day 7 | Number of participants maintaining intragastric pH > 4 for at least 12 hrs at steady-state on Day 7 | Participants who received at least one dose of a study treatment, and presented valid data from all three study periods. | Posted | Number | Participants | Treatment dose to 24-hour post-dose on Day 7 |
|
|
|
| Secondary | Number of Participants With Intragastric pH >3.5 for More Than 50% of the Time on Day 7 | Number of participants maintaining intragastric pH > 3.5 for at least 12 hrs at steady-state on Day 7 | Participants who received at least one dose of a study treatment, and presented valid data from all three study periods. | Posted | Number | Participants | Treatment dose to 24-hour post-dose on Day 7 |
|
|
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| Secondary | Percentage of Time Intragastric pH >4 Over the Nocturnal Period on Day 7 | Participants who received at least one dose of a study treatment, and presented valid data from all three study periods. | Posted | Median | Full Range | Percentage of Time | Treatment dose to 24-hour post-dose on Day 7 |
|
|
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| Secondary | Time to Achieve Sustained Intragastric pH > 3.5 at Steady-state on Day 7 | The first time to sustain median pH > 3.5 for at least 3 successive 5-minute periods within the first 2 hours after dosing with Zegerid Capsules, and Prevacid Capsules, or No treatment on the 7th day of respective treatments. If this condition was not met for any time point within the first 2 hours following dosing, a score of 120 minutes was imputed. | Participants who received at least one dose of a study treatment, and presented valid data from all three study periods. | Posted | Median | Full Range | Minutes | Treatment dose to 2-hours post-dose on Day 7 |
|
|
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| Secondary | Time to Onset of Inhibition of Acid Secretion on Day 1 | The onset of inhibition of acid secretion was the first time to sustain median pH >3.5 for each of the twenty-four successive 5-minute periods. If this condition was not met for any time point within the first 4 hours following dosing, a score of 240 minutes was imputed. | Participants who received at least one dose of a study treatment, and presented valid data from all three study periods. | Posted | Median | Full Range | Minutes | Treatment dose to onset of event on Day 1 |
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| Secondary | Number of Participants Maintaining Intragastric pH > 4 for at Least 12 Hours on Day 1 | Participants who received at least one dose of a study treatment, and presented valid data from all three study periods. | Posted | Number | Participants | Treatment dose to 24-hr post-dose on Day 1 |
|
|
|
| Secondary | Number of Participants Maintaining Intragastric pH > 3.5 for at Least 12 Hours on Day 1 | Participants who received at least one dose of a study treatment, and presented valid data from all three study periods. | Posted | Number | Participants | Treatment dose to 24-hr post-dose on Day 1 |
|
|
|
| Secondary | Percentage of Time Intragastric pH >4 Over the Nocturnal Period on Day 1 | Participants who received at least one dose of a study treatment, and presented valid data from all three study periods. | Posted | Median | Full Range | Percentage of Time | Treatment dose to 24-hour post-dose on Day 1 |
|
|
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| Secondary | Percentage of Time Intragastric pH >4 During the First 4 Hours on Day 1 | Participants who received at least one dose of a study treatment, and presented valid data from all three study periods. | Posted | Median | Full Range | Percentage of Time | Treatment dose to 4-hours post-dose on Day 1 |
|
|
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| Secondary | Time to Achieve Sustained Advantage Over No Treatment During the First 4 Hours After Dosing | The earliest time during the first 4 hours after dosing that the median pH for the treatment is over 1 unit higher than that for the No treatment during the next three 5 minute intervals. (When this condition does not occur, the time to sustained advantage will be imputed as 4 hours.) | Participants who received at least one dose of a study treatment, and presented valid data from all three study periods. | Posted | Median | Full Range | Minutes | Treatment dose to event on Day 1 and Day 7 |
|
|
|
| 1 |
| 60 |
| 4 |
| 60 |
| EG001 | Prevacid® | Participants receiving Prevacid® in Periods 1, 2 or 3. All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order. | 0 | 61 | 8 | 61 |
| EG002 | No Treatment | Participants receiving No treatment in Periods 1, 2 or 3. All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order. | 0 | 62 | 5 | 62 |
| Dizziness | Nervous system disorders | MedDRA (10.1) |
|
| Constipation | Gastrointestinal disorders | MedDRA (10.1) |
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| Flatulence | Gastrointestinal disorders | MedDRA (10.1) |
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| Vomiting | Gastrointestinal disorders | MedDRA (10.1) |
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| Influenza like illness | General disorders | MedDRA (10.1) |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (10.1) |
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| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA (10.1) |
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| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) |
|
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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 |
| 20-25 Minutes Post-dose on Day 1 |
|
p-value for 15-20 mins Post-dose on Day 1 |
| 95 |
| No |
| Superiority or Other |
| Wilcoxon (Mann-Whitney) | <0.0001 | p-value for 20-25 mins Post-dose on Day 1 | 95 | No | Superiority or Other |
| Day 7 (0-5 mins), (N=59, N=59, N=59) |
|
| <0.05 |
The statistical analysis is for Day 1 (0-5 mins). |
| 95 |
| No |
| Superiority or Other |
| Wilcoxon (Mann-Whitney) | <0.05 | The statistical analysis is for Day 7 (0-5 mins). | 95 | No | Superiority or Other |
| Wilcoxon (Mann-Whitney) | <0.05 | The statistical analysis is for Day 7 (0-5 mins). | 95 | No | Superiority or Other |
| Day 7 (N=59, N=59, N=59) |
|