Human Experimentation
Conditions
Brief summary
This study will determine differences between Proton Pump Inhibitors (PPI) formulations relative to their effects on gastric acidity.
Interventions
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy non-Asian, male or non-lactating, non-pregnant female participants who are 18-65 years of age. * Clinical laboratory test must be within normal limits or clinically acceptable to the Investigator/Sponsor. * Participants must have normal or clinically acceptable physical exam and ECG. * Participants must be free of any clinically significant disease that requires a physician's care and/or would interfere with study evaluations, procedures, or participation. * Able to understand and comply with study procedures required and able and willing to provide written informed consent prior to any study procedures being performed.
Exclusion criteria
* History of hypersensitivity, allergy or intolerance to omeprazole, or other proton pump inhibitors * History of peptic ulcer disease or other acid related gastrointestinal symptoms or heartburn with a frequency of more than one/month. * Positive H. pylori breath test at screening. * Participation in any study of an investigational treatment in the 30 days before Screening or participation in another study at any time during the period of this study * Any significant medical illness that would contraindicate participation in the study * Gastrointestinal disorder or surgery leading to impaired drug absorption * Any significant mental illness, such as schizophrenia or bipolar disorder * History (in the past year) suggestive of alcohol or drug abuse or dependence, or excessive alcohol use (\>2 units per day on average; for example \>2 bottles of beer, \>2 glasses of wine, \>2 ounces of liquor/spirits), or excessive alcohol use during the study * Any abnormal Screening laboratory value that is clinically significant in the investigator's opinion * Currently using or use of any prescription or over the counter (OTC) medications that affect gastrointestinal function, including first generation antihistamines (e.g. diphenhydramine) and anticholinergic agents within 7 days prior to 1st treatment administration. * Currently using, or use within 14 days of first treatment administration, or having a history of frequent use of antacids, OTC or Prescription (Rx) H2 receptor antagonists, or OTC or Rx use of proton pump inhibitors. * Positive urine drug/alcohol test at Screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Treatment dose to 4-hr post-dose 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Treatment dose to 4-hr post-dose 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. |
| Median Time to Achieve Intragastric pH > = 3.5 for a 10-Minute Period | Treatment dose to 4-hr post-dose on Day 1 and Day 7 | 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. |
| 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 | Treatment dose to 24-hour post-dose on Day 7 | The median intragastric pH values were recorded over a 24-hr period. |
| 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 | Treatment dose to 24-hour post-dose on Day 7 | Number of participants maintaining intragastric pH \> 4 for at least 12 hrs at steady-state on Day 7 |
| Number of Participants With Intragastric pH >3.5 for More Than 50% of the Time on Day 7 | Treatment dose to 24-hour post-dose on Day 7 | Number of participants maintaining intragastric pH \> 3.5 for at least 12 hrs at steady-state on Day 7 |
| 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 | Treatment dose to 4-hr post-dose 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. |
| Time to Achieve Sustained Intragastric pH > 3.5 at Steady-state on Day 7 | Treatment dose to 2-hours post-dose 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. |
| Time to Onset of Inhibition of Acid Secretion on Day 1 | Treatment dose to onset of event 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. |
| 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 | Treatment dose to event on Day 1 and Day 7 | 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.) |
| Percentage of Time Intragastric pH >4 Over the Nocturnal Period on Day 7 | Treatment dose to 24-hour post-dose on Day 7 | — |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Study | 63 |
| Total | 63 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Period 1 | Adverse Event | 0 | 0 | 0 | 1 | 0 | 0 |
| Period 1 | Delay in completing study procedures | 0 | 0 | 0 | 0 | 0 | 1 |
| Period 2 | Adverse Event | 0 | 0 | 0 | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | Overall Study |
|---|---|
| Age, Continuous | 27.6 years STANDARD_DEVIATION 7.12 |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 4 / 60 | 8 / 61 | 5 / 62 |
| serious Total, serious adverse events | 1 / 60 | 0 / 61 | 0 / 62 |
Outcome results
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.
Time frame: Treatment dose to 4-hr post-dose on Day 7
Population: Participants who received at least one dose of study treatment, and did not have missing values.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Zegerid | 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 | 10-15 Minutes Post-dose on Day 7 | 2.600 pH |
| Zegerid | 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 | 15-20 Minutes Post-dose on Day 7 | 3.230 pH |
| Zegerid | 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 | 20-25 Minutes Post-dose on Day 7 | 4.920 pH |
| Prevacid® | 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 | 10-15 Minutes Post-dose on Day 7 | 1.820 pH |
| Prevacid® | 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 | 15-20 Minutes Post-dose on Day 7 | 1.760 pH |
| Prevacid® | 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 | 20-25 Minutes Post-dose on Day 7 | 1.950 pH |
p-value: 0.0242Wilcoxon (Mann-Whitney)
p-value: 0.027Wilcoxon (Mann-Whitney)
p-value: 0.0067Wilcoxon (Mann-Whitney)
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.
Time frame: Treatment dose to 4-hr post-dose on Day 1
Population: Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Zegerid | 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 | 10-15 Minutes Post-dose on Day 1 | 1.330 pH |
| Zegerid | 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 | 15-20 Minutes Post-dose on Day 1 | 1.420 pH |
| Zegerid | 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 | 20-25 Minutes Post-dose on Day 1 | 1.590 pH |
| Prevacid® | 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 | 10-15 Minutes Post-dose on Day 1 | 1.070 pH |
| Prevacid® | 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 | 15-20 Minutes Post-dose on Day 1 | 1.080 pH |
| Prevacid® | 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 | 20-25 Minutes Post-dose on Day 1 | 0.990 pH |
p-value: 0.0465Wilcoxon (Mann-Whitney)
p-value: 0.0012Wilcoxon (Mann-Whitney)
p-value: <0.0001Wilcoxon (Mann-Whitney)
Secondary
Median 24-hr Intragastric pH on Day 7
The median intragastric pH values were recorded over a 24-hr period.
Time frame: Treatment dose to 24-hour post-dose on Day 7
Population: Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Zegerid | Median 24-hr Intragastric pH on Day 7 | 3.600 pH |
| Prevacid® | Median 24-hr Intragastric pH on Day 7 | 3.100 pH |
| No Treatment | Median 24-hr Intragastric pH on Day 7 | 0.800 pH |
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.
Time frame: Treatment dose to 4-hr post-dose on Day 1 and Day 7
Population: Participants who received at least one dose of study treatment, and did not have missing values.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Zegerid | Median Time to Achieve Intragastric pH > = 3.5 for a 10-Minute Period | Day 1 (N=59, N=57, N=59) | 64.867 Minutes |
| Zegerid | Median Time to Achieve Intragastric pH > = 3.5 for a 10-Minute Period | Day 7 (N=59, N=59, N=59) | 22.667 Minutes |
| Prevacid® | Median Time to Achieve Intragastric pH > = 3.5 for a 10-Minute Period | Day 1 (N=59, N=57, N=59) | 108.867 Minutes |
| Prevacid® | Median Time to Achieve Intragastric pH > = 3.5 for a 10-Minute Period | Day 7 (N=59, N=59, N=59) | 66.667 Minutes |
| No Treatment | Median Time to Achieve Intragastric pH > = 3.5 for a 10-Minute Period | Day 1 (N=59, N=57, N=59) | 240.00 Minutes |
| No Treatment | Median Time to Achieve Intragastric pH > = 3.5 for a 10-Minute Period | Day 7 (N=59, N=59, N=59) | 240.00 Minutes |
Secondary
Number of Participants Maintaining Intragastric pH > 3.5 for at Least 12 Hours on Day 1
Time frame: Treatment dose to 24-hr post-dose on Day 1
Population: Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zegerid | Number of Participants Maintaining Intragastric pH > 3.5 for at Least 12 Hours on Day 1 | 11 Participants |
| Prevacid® | Number of Participants Maintaining Intragastric pH > 3.5 for at Least 12 Hours on Day 1 | 11 Participants |
| No Treatment | Number of Participants Maintaining Intragastric pH > 3.5 for at Least 12 Hours on Day 1 | 0 Participants |
Secondary
Number of Participants Maintaining Intragastric pH > 4 for at Least 12 Hours on Day 1
Time frame: Treatment dose to 24-hr post-dose on Day 1
Population: Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zegerid | Number of Participants Maintaining Intragastric pH > 4 for at Least 12 Hours on Day 1 | 8 Participants |
| Prevacid® | Number of Participants Maintaining Intragastric pH > 4 for at Least 12 Hours on Day 1 | 5 Participants |
| No Treatment | Number of Participants Maintaining Intragastric pH > 4 for at Least 12 Hours on Day 1 | 0 Participants |
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
Time frame: Treatment dose to 24-hour post-dose on Day 7
Population: Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zegerid | Number of Participants With Intragastric pH >3.5 for More Than 50% of the Time on Day 7 | 30 Participants |
| Prevacid® | Number of Participants With Intragastric pH >3.5 for More Than 50% of the Time on Day 7 | 23 Participants |
| No Treatment | Number of Participants With Intragastric pH >3.5 for More Than 50% of the Time on Day 7 | 0 Participants |
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
Time frame: Treatment dose to 24-hour post-dose on Day 7
Population: Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zegerid | Number of Participants With Intragastric pH >4 for More Than 50% of the Time on Day 7 | 26 Participants |
| Prevacid® | Number of Participants With Intragastric pH >4 for More Than 50% of the Time on Day 7 | 18 Participants |
| No Treatment | Number of Participants With Intragastric pH >4 for More Than 50% of the Time on Day 7 | 0 Participants |
Secondary
Percentage of Time Intragastric is pH >4 Over 24-hour Period on Day 7
Time frame: Treatment dose to 24-hour post-dose on Day 7
Population: Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Zegerid | Percentage of Time Intragastric is pH >4 Over 24-hour Period on Day 7 | 40.538 Percentage of time |
| Prevacid® | Percentage of Time Intragastric is pH >4 Over 24-hour Period on Day 7 | 36.917 Percentage of time |
| No Treatment | Percentage of Time Intragastric is pH >4 Over 24-hour Period on Day 7 | 4.852 Percentage of time |
Secondary
Percentage of Time Intragastric pH >3.5 Over 24-hour Period on Day 7
Time frame: Treatment dose to 24-hours post-dose on Day 7
Population: Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Zegerid | Percentage of Time Intragastric pH >3.5 Over 24-hour Period on Day 7 | 51.321 Percentage of Time |
| Prevacid® | Percentage of Time Intragastric pH >3.5 Over 24-hour Period on Day 7 | 43.990 Percentage of Time |
| No Treatment | Percentage of Time Intragastric pH >3.5 Over 24-hour Period on Day 7 | 7.927 Percentage of Time |
Secondary
Percentage of Time Intragastric pH >4 During the First 4 Hours on Day 1
Time frame: Treatment dose to 4-hours post-dose on Day 1
Population: Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Zegerid | Percentage of Time Intragastric pH >4 During the First 4 Hours on Day 1 | 21.500 Percentage of Time |
| Prevacid® | Percentage of Time Intragastric pH >4 During the First 4 Hours on Day 1 | 9.525 Percentage of Time |
| No Treatment | Percentage of Time Intragastric pH >4 During the First 4 Hours on Day 1 | 3.667 Percentage of Time |
Secondary
Percentage of Time Intragastric pH >4 Over the Nocturnal Period on Day 1
Time frame: Treatment dose to 24-hour post-dose on Day 1
Population: Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Zegerid | Percentage of Time Intragastric pH >4 Over the Nocturnal Period on Day 1 | 0.681 Percentage of Time |
| Prevacid® | Percentage of Time Intragastric pH >4 Over the Nocturnal Period on Day 1 | 1.987 Percentage of Time |
| No Treatment | Percentage of Time Intragastric pH >4 Over the Nocturnal Period on Day 1 | 0.111 Percentage of Time |
Secondary
Percentage of Time Intragastric pH >4 Over the Nocturnal Period on Day 7
Time frame: Treatment dose to 24-hour post-dose on Day 7
Population: Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Zegerid | Percentage of Time Intragastric pH >4 Over the Nocturnal Period on Day 7 | 9.236 Percentage of Time | Full Range 17.426 |
| Prevacid® | Percentage of Time Intragastric pH >4 Over the Nocturnal Period on Day 7 | 9.685 Percentage of Time | Full Range 17.008 |
| No Treatment | Percentage of Time Intragastric pH >4 Over the Nocturnal Period on Day 7 | 0.028 Percentage of Time | — |
Secondary
Percentage Time Intragastric pH >4 During the First 4 Hours After Dosing on Day 7
Time frame: Treatment dose to 4 hours Post-dose on Day 7
Population: Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Zegerid | Percentage Time Intragastric pH >4 During the First 4 Hours After Dosing on Day 7 | 64.639 Percentage of time |
| Prevacid® | Percentage Time Intragastric pH >4 During the First 4 Hours After Dosing on Day 7 | 44.194 Percentage of time |
| No Treatment | Percentage Time Intragastric pH >4 During the First 4 Hours After Dosing on Day 7 | 6.056 Percentage of time |
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.
Time frame: Treatment dose to 4-hr post-dose on Day 1 and Day 7
Population: Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Zegerid | 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 | Day 1 (0-5 mins), (N=59, N=57, N=59) | 1.050 pH |
| Zegerid | 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 | Day 7 (0-5 mins), (N=59, N=59, N=59) | 1.840 pH |
| Prevacid® | 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 | Day 1 (0-5 mins), (N=59, N=57, N=59) | 1.180 pH |
| Prevacid® | 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 | Day 7 (0-5 mins), (N=59, N=59, N=59) | 1.950 pH |
| No Treatment | 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 | Day 1 (0-5 mins), (N=59, N=57, N=59) | 0.92 pH |
| No Treatment | 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 | Day 7 (0-5 mins), (N=59, N=59, N=59) | 0.82 pH |
p-value: <0.05Wilcoxon (Mann-Whitney)
p-value: <0.05Wilcoxon (Mann-Whitney)
p-value: <0.05Wilcoxon (Mann-Whitney)
p-value: <0.05Wilcoxon (Mann-Whitney)
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.)
Time frame: Treatment dose to event on Day 1 and Day 7
Population: Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Zegerid | Time to Achieve Sustained Advantage Over No Treatment During the First 4 Hours After Dosing | Day 1 (N=59, N=57) | 35.000 Minutes |
| Zegerid | Time to Achieve Sustained Advantage Over No Treatment During the First 4 Hours After Dosing | Day 7 (N=59, N=59) | 10.000 Minutes |
| Prevacid® | Time to Achieve Sustained Advantage Over No Treatment During the First 4 Hours After Dosing | Day 1 (N=59, N=57) | 85.000 Minutes |
| Prevacid® | Time to Achieve Sustained Advantage Over No Treatment During the First 4 Hours After Dosing | Day 7 (N=59, N=59) | 5.000 Minutes |
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.
Time frame: Treatment dose to 2-hours post-dose on Day 7
Population: Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Zegerid | Time to Achieve Sustained Intragastric pH > 3.5 at Steady-state on Day 7 | 25.000 Minutes |
| Prevacid® | Time to Achieve Sustained Intragastric pH > 3.5 at Steady-state on Day 7 | 65.000 Minutes |
| No Treatment | Time to Achieve Sustained Intragastric pH > 3.5 at Steady-state on Day 7 | 100.000 Minutes |
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.
Time frame: Treatment dose to onset of event on Day 1
Population: Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Zegerid | Time to Onset of Inhibition of Acid Secretion on Day 1 | 240.00 Minutes | Full Range 71.663 |
| Prevacid® | Time to Onset of Inhibition of Acid Secretion on Day 1 | 240.00 Minutes | Full Range 48.209 |
| No Treatment | Time to Onset of Inhibition of Acid Secretion on Day 1 | 240.00 Minutes | Full Range 18.226 |