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Trial Outcomes & Findings for A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® (CL2007-17 )(P07813)(COMPLETED) (NCT NCT00674115)

NCT ID: NCT00674115

Last Updated: 2015-03-11

Results Overview

The change from Baseline in median pH was calculated as: median pH on Day 7 minus median pH at Baseline. PH measures how acidic or basic a substance is. The pH scale ranges from 0 to 14. A pH of 7 is neutral. A pH less than 7 is acidic. A pH greater than 7 is basic.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

60 participants

Primary outcome timeframe

Baseline and 7 days

Results posted on

2015-03-11

Participant Flow

60 participants were randomized to either 1-Day or 7-Day Dosing in this crossover study (participants in both groups received 1 treatment \[Zegerid or Prilosec\], followed by washout period, followed by the other treatment \[Prilosec or Zegerid\]). Participants in the 1-day dosing group also received sodium bicarbonate after a washout period.

Participant milestones

Participant milestones
Measure
Zegerid, Prilosec, Sodium Bicarbonate
Participants received Zegerid Oral Suspension (omeprazole 20 mg and sodium bicarbonate 1680 mg) in the first intervention, Prilosec over-the-counter (OTC) Tablets (omeprazole 20 mg) in the second intervention (after washout period), and Sodium Bicarbonate Oral Suspension (sodium bicarbonate 1680 mg) in the third intervention (after washout period)
Prilosec, Zegerid, Sodium Bicarbonate
Participants received Prilosec OTC Tablets (omeprazole 20 mg) in the first intervention, Zegerid Oral Suspension (omeprazole 20 mg and sodium bicarbonate 1680 mg) in the second intervention (after washout period), and Sodium Bicarbonate Oral Suspension (sodium bicarbonate 1680 mg) in the third intervention (after washout period)
Zegerid, Prilosec
Participants received Zegerid Oral Suspension (omeprazole 20 mg and sodium bicarbonate 1680 mg) in the first intervention and Prilosec OTC Tablets (omeprazole 20 mg) in the second intervention (after washout period)
Prilosec, Zegerid
Participants received Prilosec OTC Tablets (omeprazole 20 mg) in the first intervention and Zegerid Oral Suspension (omeprazole 20 mg and sodium bicarbonate 1680 mg) in the second intervention (after washout period)
First Intervention
STARTED
14
16
14
16
First Intervention
COMPLETED
14
16
14
16
First Intervention
NOT COMPLETED
0
0
0
0
Washout Period of 2 Weeks
STARTED
14
16
0
0
Washout Period of 2 Weeks
COMPLETED
14
16
0
0
Washout Period of 2 Weeks
NOT COMPLETED
0
0
0
0
Second Intervention
STARTED
14
16
14
16
Second Intervention
COMPLETED
14
16
14
16
Second Intervention
NOT COMPLETED
0
0
0
0
Third Intervention
STARTED
14
16
0
0
Third Intervention
COMPLETED
14
16
0
0
Third Intervention
NOT COMPLETED
0
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® (CL2007-17 )(P07813)(COMPLETED)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Entire Study Population
n=60 Participants
Age, Continuous
25.3 years
STANDARD_DEVIATION 4.37 • n=5 Participants
Sex: Female, Male
Female
22 Participants
n=5 Participants
Sex: Female, Male
Male
38 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 7 days

Population: 25 participants in each arm had good quality tracings and were included in the efficacy analysis.

The change from Baseline in median pH was calculated as: median pH on Day 7 minus median pH at Baseline. PH measures how acidic or basic a substance is. The pH scale ranges from 0 to 14. A pH of 7 is neutral. A pH less than 7 is acidic. A pH greater than 7 is basic.

Outcome measures

Outcome measures
Measure
Zegerid
n=25 Participants
Participants in the 7-Day Dosing group. Measurements taken on the 7th day of Zegerid administration.
Prilosec
n=25 Participants
Participants in the 7-Day Dosing group. Measurements taken on the 7th day of Prilosec administration.
Change From Baseline in Median 24-hour Intragastric pH on the 7th Day of Drug Administration
Day 7 Score
3.250 pH scale
Full Range 1.300 • Interval 1.23 to 5.3
4.160 pH scale
Full Range 1.260 • Interval 1.46 to 5.78
Change From Baseline in Median 24-hour Intragastric pH on the 7th Day of Drug Administration
Change from Baseline in PH
2.180 pH scale
Full Range 1.320 • Interval -0.13 to 4.3
2.900 pH scale
Full Range 1.244 • Interval 0.1 to 4.21

Adverse Events

Zegerid (7-Day Dosing)

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Prilosec (7-Day Dosing)

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Sodium Bicarbonate (1-Day Dosing)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Zegerid (1-Day Dosing)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Prilosec (1-Day Dosing)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Zegerid (7-Day Dosing)
n=30 participants at risk
Prilosec (7-Day Dosing)
n=30 participants at risk
Sodium Bicarbonate (1-Day Dosing)
n=30 participants at risk
Following completion of the 1-day dosing 2-way crossover study, and a subsequent washout period (minimum of 2 weeks), all participants then received a single administration of sodium bicarbonate 1680 mg.
Zegerid (1-Day Dosing)
n=30 participants at risk
Prilosec (1-Day Dosing)
n=30 participants at risk
Gastrointestinal disorders
Diarrhea
6.7%
2/30 • Number of events 2
6.7%
2/30 • Number of events 2
0.00%
0/30
0.00%
0/30
0.00%
0/30

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: OTHER