Trial Outcomes & Findings for Pharmacodynamic Study Comparing the Effects of Two Different Forms of Omeprazole (P07812) (COMPLETED) (NCT NCT01077076)
NCT ID: NCT01077076
Last Updated: 2015-03-11
Results Overview
Early effectiveness of treatment is evaluated as the percent time with intragastric pH\>4 during the first 4 hours following administration of respective treatments
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
30 participants
Primary outcome timeframe
4 hours after dose on Day 4
Results posted on
2015-03-11
Participant Flow
Participant milestones
| Measure |
Zegerid/Prilosec/Placebo
Participants received Zegerid over-the-counter (OTC) Capsules (20 mg omeprazole and 1100 mg sodium bicarbonate) in the first intervention, Prilosec OTC Tablets (20 mg-equivalent omeprazole) in the second intervention (after the washout period), and Placebo Capsules in the third intervention (after the washout period).
|
Zegerid/Placebo/Prilosec
Participants received Zegerid OTC Capsules (20 mg omeprazole and 1100 mg sodium bicarbonate) in the first intervention, Placebo Capsules in the second intervention (after the washout period), and Prilosec OTC Tablets (20 mg-equivalent omeprazole) in the third intervention (after the washout period).
|
Prilosec/Zegerid/Placebo
Participants received Prilosec OTC Tablets (20 mg-equivalent omeprazole) in the first intervention, Zegerid OTC Capsules (20 mg omeprazole and 1100 mg sodium bicarbonate) in the second intervention (after the washout period), and Placebo Capsules in the third intervention (after the washout period).
|
Prilosec/Placebo/Zegerid
Participants received Prilosec OTC Tablets (20 mg-equivalent omeprazole) in the first intervention, Placebo Capsules in the second intervention (after the washout period), and Zegerid OTC Capsules (20 mg omeprazole and 1100 mg sodium bicarbonate) in the third intervention (after the washout period).
|
Placebo/Zegerid/Prilosec
Participants received Placebo Capsules in the first intervention, Zegerid OTC Capsules (20 mg omeprazole and 1100 mg sodium bicarbonate) in the second intervention (after the washout period), and Prilosec OTC Tablets (20 mg-equivalent omeprazole) in the third intervention (after the washout period).
|
Placebo/Prilosec/Zegerid
Participants received Placebo Capsules in the first intervention, Prilosec OTC Tablets (20 mg-equivalent omeprazole) in the second intervention (after the washout period), and Zegerid OTC Capsules (20 mg omeprazole and 1100 mg sodium bicarbonate) in the third intervention (after the washout period).
|
|---|---|---|---|---|---|---|
|
First Intervention
STARTED
|
5
|
5
|
5
|
5
|
5
|
5
|
|
First Intervention
COMPLETED
|
4
|
5
|
5
|
5
|
5
|
5
|
|
First Intervention
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period of 2 Weeks
STARTED
|
4
|
5
|
5
|
5
|
5
|
5
|
|
Washout Period of 2 Weeks
COMPLETED
|
4
|
5
|
5
|
5
|
5
|
5
|
|
Washout Period of 2 Weeks
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Second Intervention
STARTED
|
4
|
5
|
5
|
5
|
5
|
5
|
|
Second Intervention
COMPLETED
|
4
|
5
|
5
|
5
|
5
|
5
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Third Intervention
STARTED
|
4
|
5
|
5
|
5
|
5
|
5
|
|
Third Intervention
COMPLETED
|
4
|
5
|
5
|
5
|
5
|
4
|
|
Third Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Zegerid/Prilosec/Placebo
Participants received Zegerid over-the-counter (OTC) Capsules (20 mg omeprazole and 1100 mg sodium bicarbonate) in the first intervention, Prilosec OTC Tablets (20 mg-equivalent omeprazole) in the second intervention (after the washout period), and Placebo Capsules in the third intervention (after the washout period).
|
Zegerid/Placebo/Prilosec
Participants received Zegerid OTC Capsules (20 mg omeprazole and 1100 mg sodium bicarbonate) in the first intervention, Placebo Capsules in the second intervention (after the washout period), and Prilosec OTC Tablets (20 mg-equivalent omeprazole) in the third intervention (after the washout period).
|
Prilosec/Zegerid/Placebo
Participants received Prilosec OTC Tablets (20 mg-equivalent omeprazole) in the first intervention, Zegerid OTC Capsules (20 mg omeprazole and 1100 mg sodium bicarbonate) in the second intervention (after the washout period), and Placebo Capsules in the third intervention (after the washout period).
|
Prilosec/Placebo/Zegerid
Participants received Prilosec OTC Tablets (20 mg-equivalent omeprazole) in the first intervention, Placebo Capsules in the second intervention (after the washout period), and Zegerid OTC Capsules (20 mg omeprazole and 1100 mg sodium bicarbonate) in the third intervention (after the washout period).
|
Placebo/Zegerid/Prilosec
Participants received Placebo Capsules in the first intervention, Zegerid OTC Capsules (20 mg omeprazole and 1100 mg sodium bicarbonate) in the second intervention (after the washout period), and Prilosec OTC Tablets (20 mg-equivalent omeprazole) in the third intervention (after the washout period).
|
Placebo/Prilosec/Zegerid
Participants received Placebo Capsules in the first intervention, Prilosec OTC Tablets (20 mg-equivalent omeprazole) in the second intervention (after the washout period), and Zegerid OTC Capsules (20 mg omeprazole and 1100 mg sodium bicarbonate) in the third intervention (after the washout period).
|
|---|---|---|---|---|---|---|
|
First Intervention
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Third Intervention
Death in the participant's family
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Pharmacodynamic Study Comparing the Effects of Two Different Forms of Omeprazole (P07812) (COMPLETED)
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=30 Participants
|
|---|---|
|
Age, Continuous
|
27.8 years
STANDARD_DEVIATION 7.25 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 hours after dose on Day 4Population: Pharmacodynamic-Evaluable Population: All participants who presented valid data from all three study periods. One participant was dropped from the Pharmacodynamic-Evaluable Population in the Prilosec OTC Tablets group because of invalid pH tracings at Day 4. Therefore, the number of participants included at Day 4 in this group was 26.
Early effectiveness of treatment is evaluated as the percent time with intragastric pH\>4 during the first 4 hours following administration of respective treatments
Outcome measures
| Measure |
Zegerid OTC Capsules
n=27 Participants
20 mg omeprazole and 1100 mg sodium bicarbonate
|
Prilosec OTC Tablets
n=27 Participants
20 mg-equivalent omeprazole
|
Placebo Capsules
n=27 Participants
|
|---|---|---|---|
|
Percent Time With Intragastric pH>4 During the First 4 Hours Following Administration on Day 4 of Treatment
|
53.265 Percentage of Time
Standard Deviation 27.588
|
46.933 Percentage of Time
Standard Deviation 21.885
|
17.215 Percentage of Time
Standard Deviation 15.432
|
Adverse Events
Zegerid OTC Capsules
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Prilosec OTC Tablets
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo Capsules
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Zegerid OTC Capsules
n=30 participants at risk
20 mg omeprazole and 1100 mg sodium bicarbonate
|
Prilosec OTC Tablets
n=29 participants at risk
20 mg-equivalent omeprazole
|
Placebo Capsules
n=29 participants at risk
|
|---|---|---|---|
|
Infections and infestations
Upper Respiratory Tract Infection
|
6.7%
2/30 • Number of events 2
|
6.9%
2/29 • Number of events 2
|
0.00%
0/29
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Schering-Plough HealthCare Products, Inc. reserves all publication and presentation rights.
- Publication restrictions are in place
Restriction type: OTHER