Trial Outcomes & Findings for Study to Compare Gastric Inhibition of Two Proton Pump Inhibitors (CL2008-18)(P07815)(COMPLETED) (NCT NCT01005719)
NCT ID: NCT01005719
Last Updated: 2015-03-11
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
63 participants
Primary outcome timeframe
Treatment dose to 4-hr post-dose on Day 7
Results posted on
2015-03-11
Participant Flow
Participant milestones
| Measure |
Zegerid-Prevacid®-No Treatment
Participants received Zegerid in Period 1, Prevacid® in Period 2 and No treatment in Period 3.
|
Zegerid-No Treatment-Prevacid®
Participants received Zegerid in Period 1, No treatment in Period 2 and Prevacid® in Period 3
|
Prevacid®-Zegerid-No Treatment
Participants received Prevacid® in Period 1, Zegerid in Period 2 and No treatment in Period 3
|
Prevacid®-No Treatment-Zegerid
Participants received Prevacid® in Period 1, No treatment in Period 2 and Zegerid in Period 3
|
No Treatment-Zegerid-Prevacid®
Participants received No treatment in Period 1, Zegerid in Period 2 and Prevacid® in Period 3
|
No Treatment-Prevacid®-Zegerid
Participants received No treatment in Period 1, Prevacid® in Period 2 and Zegerid in Period 3
|
|---|---|---|---|---|---|---|
|
Period 1
STARTED
|
10
|
10
|
10
|
11
|
11
|
11
|
|
Period 1
COMPLETED
|
10
|
10
|
10
|
10
|
11
|
10
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
1
|
|
Period 2
STARTED
|
10
|
10
|
10
|
10
|
11
|
10
|
|
Period 2
COMPLETED
|
10
|
10
|
10
|
10
|
10
|
9
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Period 3
STARTED
|
10
|
10
|
10
|
10
|
10
|
9
|
|
Period 3
COMPLETED
|
10
|
10
|
10
|
10
|
10
|
9
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Zegerid-Prevacid®-No Treatment
Participants received Zegerid in Period 1, Prevacid® in Period 2 and No treatment in Period 3.
|
Zegerid-No Treatment-Prevacid®
Participants received Zegerid in Period 1, No treatment in Period 2 and Prevacid® in Period 3
|
Prevacid®-Zegerid-No Treatment
Participants received Prevacid® in Period 1, Zegerid in Period 2 and No treatment in Period 3
|
Prevacid®-No Treatment-Zegerid
Participants received Prevacid® in Period 1, No treatment in Period 2 and Zegerid in Period 3
|
No Treatment-Zegerid-Prevacid®
Participants received No treatment in Period 1, Zegerid in Period 2 and Prevacid® in Period 3
|
No Treatment-Prevacid®-Zegerid
Participants received No treatment in Period 1, Prevacid® in Period 2 and Zegerid in Period 3
|
|---|---|---|---|---|---|---|
|
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
Study to Compare Gastric Inhibition of Two Proton Pump Inhibitors (CL2008-18)(P07815)(COMPLETED)
Baseline characteristics by cohort
| Measure |
Overall Study
n=63 Participants
|
|---|---|
|
Age, Continuous
|
27.6 years
STANDARD_DEVIATION 7.12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Treatment dose to 4-hr post-dose on Day 7Population: Participants who received at least one dose of study treatment, and did not have missing values.
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.
Outcome measures
| Measure |
Zegerid
n=59 Participants
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.
|
Prevacid®
n=59 Participants
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.
|
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.
|
|---|---|---|---|
|
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
Interval 0.34 to 8.25
|
1.950 pH
Interval 0.45 to 7.04
|
—
|
|
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
Interval 0.52 to 7.94
|
1.820 pH
Interval 0.64 to 6.38
|
—
|
|
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
Interval 0.45 to 8.16
|
1.760 pH
Interval 0.59 to 6.78
|
—
|
SECONDARY outcome
Timeframe: Treatment dose to 4-hr post-dose on Day 1Population: Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.
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.
Outcome measures
| Measure |
Zegerid
n=59 Participants
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.
|
Prevacid®
n=57 Participants
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.
|
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.
|
|---|---|---|---|
|
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
Interval 0.28 to 8.81
|
1.070 pH
Interval 0.23 to 6.37
|
—
|
|
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
Interval 0.19 to 8.4
|
1.080 pH
Interval 0.27 to 2.9
|
—
|
|
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
Interval 0.15 to 9.0
|
0.990 pH
Interval 0.1 to 4.67
|
—
|
SECONDARY outcome
Timeframe: Treatment dose to 4-hr post-dose on Day 1 and Day 7Population: Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.
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.
Outcome measures
| Measure |
Zegerid
n=59 Participants
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.
|
Prevacid®
n=59 Participants
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.
|
No Treatment
n=59 Participants
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.
|
|---|---|---|---|
|
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
Interval 0.1 to 6.78
|
1.950 pH
Interval 0.5 to 7.88
|
0.82 pH
Interval 0.25 to 7.0
|
|
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
Interval 0.37 to 6.83
|
1.180 pH
Interval 0.27 to 7.03
|
0.92 pH
Interval 0.1 to 4.01
|
SECONDARY outcome
Timeframe: Treatment dose to 4-hr post-dose on Day 1 and Day 7Population: Participants who received at least one dose of study treatment, and did not have missing values.
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.
Outcome measures
| Measure |
Zegerid
n=59 Participants
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.
|
Prevacid®
n=59 Participants
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.
|
No Treatment
n=59 Participants
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.
|
|---|---|---|---|
|
Median Time to Achieve Intragastric pH > = 3.5 for a 10-Minute Period
Day 1 (N=59, N=57, N=59)
|
64.867 Minutes
Interval 0.0 to 240.0
|
108.867 Minutes
Interval 0.0 to 240.0
|
240.00 Minutes
Interval 2.27 to 240.0
|
|
Median Time to Achieve Intragastric pH > = 3.5 for a 10-Minute Period
Day 7 (N=59, N=59, N=59)
|
22.667 Minutes
Interval 0.0 to 240.0
|
66.667 Minutes
Interval 0.0 to 240.0
|
240.00 Minutes
Interval 0.0 to 240.0
|
SECONDARY outcome
Timeframe: Treatment dose to 4 hours Post-dose on Day 7Population: Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.
Outcome measures
| Measure |
Zegerid
n=59 Participants
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.
|
Prevacid®
n=59 Participants
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.
|
No Treatment
n=59 Participants
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.
|
|---|---|---|---|
|
Percentage Time Intragastric pH >4 During the First 4 Hours After Dosing on Day 7
|
64.639 Percentage of time
Interval 1.36 to 100.0
|
44.194 Percentage of time
Interval 0.0 to 100.0
|
6.056 Percentage of time
Interval 0.0 to 70.28
|
SECONDARY outcome
Timeframe: Treatment dose to 24-hour post-dose on Day 7Population: Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.
The median intragastric pH values were recorded over a 24-hr period.
Outcome measures
| Measure |
Zegerid
n=59 Participants
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.
|
Prevacid®
n=59 Participants
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.
|
No Treatment
n=59 Participants
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.
|
|---|---|---|---|
|
Median 24-hr Intragastric pH on Day 7
|
3.600 pH
Interval 0.69 to 6.64
|
3.100 pH
Interval 0.22 to 6.58
|
0.800 pH
Interval 0.1 to 3.19
|
SECONDARY outcome
Timeframe: Treatment dose to 24-hour post-dose on Day 7Population: Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.
Outcome measures
| Measure |
Zegerid
n=59 Participants
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.
|
Prevacid®
n=59 Participants
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.
|
No Treatment
n=59 Participants
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.
|
|---|---|---|---|
|
Percentage of Time Intragastric is pH >4 Over 24-hour Period on Day 7
|
40.538 Percentage of time
Interval 1.39 to 81.26
|
36.917 Percentage of time
Interval 1.18 to 92.75
|
4.852 Percentage of time
Interval 0.26 to 35.28
|
SECONDARY outcome
Timeframe: Treatment dose to 24-hours post-dose on Day 7Population: Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.
Outcome measures
| Measure |
Zegerid
n=59 Participants
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.
|
Prevacid®
n=59 Participants
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.
|
No Treatment
n=59 Participants
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.
|
|---|---|---|---|
|
Percentage of Time Intragastric pH >3.5 Over 24-hour Period on Day 7
|
51.321 Percentage of Time
Interval 1.81 to 89.27
|
43.990 Percentage of Time
Interval 3.4 to 93.44
|
7.927 Percentage of Time
Interval 0.34 to 41.15
|
SECONDARY outcome
Timeframe: Treatment dose to 24-hour post-dose on Day 7Population: Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.
Number of participants maintaining intragastric pH \> 4 for at least 12 hrs at steady-state on Day 7
Outcome measures
| Measure |
Zegerid
n=59 Participants
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.
|
Prevacid®
n=59 Participants
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.
|
No Treatment
n=59 Participants
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.
|
|---|---|---|---|
|
Number of Participants With Intragastric pH >4 for More Than 50% of the Time on Day 7
|
26 Participants
|
18 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Treatment dose to 24-hour post-dose on Day 7Population: Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.
Number of participants maintaining intragastric pH \> 3.5 for at least 12 hrs at steady-state on Day 7
Outcome measures
| Measure |
Zegerid
n=59 Participants
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.
|
Prevacid®
n=59 Participants
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.
|
No Treatment
n=59 Participants
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.
|
|---|---|---|---|
|
Number of Participants With Intragastric pH >3.5 for More Than 50% of the Time on Day 7
|
30 Participants
|
23 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Treatment dose to 24-hour post-dose on Day 7Population: Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.
Outcome measures
| Measure |
Zegerid
n=59 Participants
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.
|
Prevacid®
n=58 Participants
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.
|
No Treatment
n=58 Participants
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.
|
|---|---|---|---|
|
Percentage of Time Intragastric pH >4 Over the Nocturnal Period on Day 7
|
9.236 Percentage of Time
Full Range 17.426 • Interval 0.0 to 65.28
|
9.685 Percentage of Time
Full Range 17.008 • Interval 0.0 to 90.24
|
0.028 Percentage of Time
Interval 0.0 to 61.01
|
SECONDARY outcome
Timeframe: Treatment dose to 2-hours post-dose on Day 7Population: Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.
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.
Outcome measures
| Measure |
Zegerid
n=59 Participants
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.
|
Prevacid®
n=59 Participants
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.
|
No Treatment
n=59 Participants
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.
|
|---|---|---|---|
|
Time to Achieve Sustained Intragastric pH > 3.5 at Steady-state on Day 7
|
25.000 Minutes
Interval 5.0 to 120.0
|
65.000 Minutes
Interval 5.0 to 120.0
|
100.000 Minutes
Interval 5.0 to 120.0
|
SECONDARY outcome
Timeframe: Treatment dose to onset of event on Day 1Population: Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.
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.
Outcome measures
| Measure |
Zegerid
n=59 Participants
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.
|
Prevacid®
n=57 Participants
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.
|
No Treatment
n=59 Participants
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.
|
|---|---|---|---|
|
Time to Onset of Inhibition of Acid Secretion on Day 1
|
240.00 Minutes
Full Range 71.663 • Interval 5.0 to 240.0
|
240.00 Minutes
Full Range 48.209 • Interval 80.0 to 240.0
|
240.00 Minutes
Full Range 18.226 • Interval 100.0 to 240.0
|
SECONDARY outcome
Timeframe: Treatment dose to 24-hr post-dose on Day 1Population: Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.
Outcome measures
| Measure |
Zegerid
n=59 Participants
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.
|
Prevacid®
n=57 Participants
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.
|
No Treatment
n=59 Participants
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.
|
|---|---|---|---|
|
Number of Participants Maintaining Intragastric pH > 4 for at Least 12 Hours on Day 1
|
8 Participants
|
5 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Treatment dose to 24-hr post-dose on Day 1Population: Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.
Outcome measures
| Measure |
Zegerid
n=59 Participants
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.
|
Prevacid®
n=57 Participants
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.
|
No Treatment
n=59 Participants
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.
|
|---|---|---|---|
|
Number of Participants Maintaining Intragastric pH > 3.5 for at Least 12 Hours on Day 1
|
11 Participants
|
11 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Treatment dose to 24-hour post-dose on Day 1Population: Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.
Outcome measures
| Measure |
Zegerid
n=59 Participants
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.
|
Prevacid®
n=57 Participants
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.
|
No Treatment
n=59 Participants
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.
|
|---|---|---|---|
|
Percentage of Time Intragastric pH >4 Over the Nocturnal Period on Day 1
|
0.681 Percentage of Time
Interval 0.0 to 65.15
|
1.987 Percentage of Time
Interval 0.0 to 98.68
|
0.111 Percentage of Time
Interval 0.0 to 36.49
|
SECONDARY outcome
Timeframe: Treatment dose to 4-hours post-dose on Day 1Population: Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.
Outcome measures
| Measure |
Zegerid
n=59 Participants
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.
|
Prevacid®
n=57 Participants
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.
|
No Treatment
n=59 Participants
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.
|
|---|---|---|---|
|
Percentage of Time Intragastric pH >4 During the First 4 Hours on Day 1
|
21.500 Percentage of Time
Interval 0.0 to 91.22
|
9.525 Percentage of Time
Interval 0.0 to 73.26
|
3.667 Percentage of Time
Interval 0.0 to 58.64
|
SECONDARY outcome
Timeframe: Treatment dose to event on Day 1 and Day 7Population: Participants who received at least one dose of a study treatment, and presented valid data from all three study periods.
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.)
Outcome measures
| Measure |
Zegerid
n=59 Participants
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.
|
Prevacid®
n=59 Participants
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.
|
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.
|
|---|---|---|---|
|
Time to Achieve Sustained Advantage Over No Treatment During the First 4 Hours After Dosing
Day 1 (N=59, N=57)
|
35.000 Minutes
Interval 0.0 to 240.0
|
85.000 Minutes
Interval 0.0 to 240.0
|
—
|
|
Time to Achieve Sustained Advantage Over No Treatment During the First 4 Hours After Dosing
Day 7 (N=59, N=59)
|
10.000 Minutes
Interval 0.0 to 240.0
|
5.000 Minutes
Interval 0.0 to 240.0
|
—
|
Adverse Events
Zegerid
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Prevacid®
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
No Treatment
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Zegerid
n=60 participants at risk
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.
|
Prevacid®
n=61 participants at risk
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.
|
No Treatment
n=62 participants at risk
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.
|
|---|---|---|---|
|
Infections and infestations
Appendicitis
|
1.7%
1/60
Adverse events were collected for all participants who received at least one dose of study treatment.
|
0.00%
0/61
Adverse events were collected for all participants who received at least one dose of study treatment.
|
0.00%
0/62
Adverse events were collected for all participants who received at least one dose of study treatment.
|
Other adverse events
| Measure |
Zegerid
n=60 participants at risk
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.
|
Prevacid®
n=61 participants at risk
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.
|
No Treatment
n=62 participants at risk
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.
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
3.3%
2/60
Adverse events were collected for all participants who received at least one dose of study treatment.
|
6.6%
4/61
Adverse events were collected for all participants who received at least one dose of study treatment.
|
6.5%
4/62
Adverse events were collected for all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/60
Adverse events were collected for all participants who received at least one dose of study treatment.
|
1.6%
1/61
Adverse events were collected for all participants who received at least one dose of study treatment.
|
0.00%
0/62
Adverse events were collected for all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
1.7%
1/60
Adverse events were collected for all participants who received at least one dose of study treatment.
|
1.6%
1/61
Adverse events were collected for all participants who received at least one dose of study treatment.
|
0.00%
0/62
Adverse events were collected for all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Flatulence
|
1.7%
1/60
Adverse events were collected for all participants who received at least one dose of study treatment.
|
1.6%
1/61
Adverse events were collected for all participants who received at least one dose of study treatment.
|
0.00%
0/62
Adverse events were collected for all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/60
Adverse events were collected for all participants who received at least one dose of study treatment.
|
1.6%
1/61
Adverse events were collected for all participants who received at least one dose of study treatment.
|
0.00%
0/62
Adverse events were collected for all participants who received at least one dose of study treatment.
|
|
General disorders
Influenza like illness
|
0.00%
0/60
Adverse events were collected for all participants who received at least one dose of study treatment.
|
1.6%
1/61
Adverse events were collected for all participants who received at least one dose of study treatment.
|
0.00%
0/62
Adverse events were collected for all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/60
Adverse events were collected for all participants who received at least one dose of study treatment.
|
1.6%
1/61
Adverse events were collected for all participants who received at least one dose of study treatment.
|
0.00%
0/62
Adverse events were collected for all participants who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/60
Adverse events were collected for all participants who received at least one dose of study treatment.
|
0.00%
0/61
Adverse events were collected for all participants who received at least one dose of study treatment.
|
1.6%
1/62
Adverse events were collected for all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/60
Adverse events were collected for all participants who received at least one dose of study treatment.
|
1.6%
1/61
Adverse events were collected for all participants who received at least one dose of study treatment.
|
0.00%
0/62
Adverse events were collected for all participants who received at least one dose of study treatment.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER