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Trial Outcomes & Findings for A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® (Study CL2008-02)(P07814)(COMPLETED) (NCT NCT00765206)

NCT ID: NCT00765206

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. 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 enrolled: 30 participants were randomized to 1-Day Dosing and 30 participants were randomized to 7-Day Dosing. This was a crossover study, ie, participants in both groups received one treatment \[Zegerid or Prilosec\], followed by a 2-week washout period, followed by the other treatment \[Prilosec or Zegerid\].

Participant milestones

Participant milestones
Measure
Zegerid First, Then Prilosec (1- Day Dosing)
Participants received Zegerid Over-the-counter (OTC) Capsules (omeprazole 20 mg and sodium bicarbonate 1100 mg) in the first intervention and Prilosec OTC Tablets (omeprazole 20 mg) in the second intervention (after washout period)
Prilosec First, Then Zegerid (1-Day Dosing)
Participants received Prilosec OTC Tablets (omeprazole 20 mg) in the first intervention and Zegerid OTC Capsules (omeprazole 20 mg and sodium bicarbonate 1100 mg) in the second intervention (after washout period)
Zegerid First, Then Prilosec ( 7-Day Dosing)
Participants received Zegerid OTC Capsules (omeprazole 20 mg and sodium bicarbonate 1100 mg) in the first intervention and Prilosec OTC Tablets (omeprazole 20 mg) in the second intervention (after washout period)
Prilosec First, Then Zegerid (7-Day Dosing)
Participants received Prilosec OTC Tablets (omeprazole 20 mg) in the first intervention and Zegerid OTC Capsules (omeprazole 20 mg and sodium bicarbonate 1100 mg) in the second intervention (after washout period)
First Intervention
STARTED
15
15
15
15
First Intervention
COMPLETED
15
15
15
15
First Intervention
NOT COMPLETED
0
0
0
0
Washout Period of 14 Days
STARTED
15
15
15
15
Washout Period of 14 Days
COMPLETED
15
15
15
15
Washout Period of 14 Days
NOT COMPLETED
0
0
0
0
Second Intervention
STARTED
15
15
15
15
Second Intervention
COMPLETED
15
15
15
15
Second Intervention
NOT COMPLETED
0
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® (Study CL2008-02)(P07814)(COMPLETED)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Entire Study Population
n=60 Participants
Age, Continuous
26.6 years
STANDARD_DEVIATION 8.04 • n=5 Participants
Sex: Female, Male
Female
29 Participants
n=5 Participants
Sex: Female, Male
Male
31 Participants
n=5 Participants
Region of Enrollment
United States
60 participants
n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 7 days

The change from Baseline in median pH was calculated as: median pH on Day 7 minus median pH at Baseline. 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=30 Participants
Participants in the 7-Day Dosing group. Measurements taken on the 7th day of Zegerid administration.
Prilosec
n=30 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
4.575 pH scale
Full Range 1.349 • Interval 1.33 to 5.98
3.980 pH scale
Full Range 1.433 • Interval 1.37 to 5.94
Change From Baseline in Median 24-hour Intragastric pH on the 7th Day of Drug Administration
Change from Baseline in pH
3.165 pH scale
Full Range 1.360 • Interval 0.03 to 4.75
2.550 pH scale
Full Range 1.478 • Interval -0.89 to 4.46

Adverse Events

Zegerid

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

Prilosec

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

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

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