A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® (Study CL2008-02)(P07814)(COMPLETED)
Randomized, Crossover Pharmacodynamic Study Comparing the Effects of Zegerid® (20 mg Omeprazole/Sodium Bicarbonate) and Prilosec OTC® Tablets (20 Mg-equivalent Omeprazole)
3 other identifiers
interventional
60
0 countries
N/A
Brief Summary
Open-label randomized crossover design study. 60 participants will be evaluated on Day 1 to compare effects on stomach acid; 30 participants will continue treatment for 7 days and will have repeat evaluations at Day 7.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started May 2008
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 30, 2008
CompletedFirst Posted
Study publicly available on registry
October 2, 2008
CompletedResults Posted
Study results publicly available
April 30, 2010
CompletedMarch 11, 2015
February 1, 2015
3 months
September 30, 2008
August 28, 2009
February 20, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Median 24-hour Intragastric pH on the 7th Day of Drug Administration
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.
Baseline and 7 days
Study Arms (2)
Zegerid
EXPERIMENTALOmeprazole 20 mg /sodium bicarbonate 1100 mg over-the-counter (OTC) Capsule
Prilosec
ACTIVE COMPARATOROmeprazole magnesium 20 mg OTC tablet
Interventions
Single dose of omeprazole/sodium bicarbonate per day for either 1 or 7 days.
Single dose of omeprazole magnesium per day for either 1 or 7 days.
Eligibility Criteria
You may qualify if:
- Normal subjects who are 18-65 years of age.
- Non-childbearing potential females or those using birth control.
You may not qualify if:
- History of hypersensitivity, allergy or intolerance to omeprazole or other proton pump inhibitors
- History of significant gastrointestinal disease
- Any significant medical illness
- Gastrointestinal disorder or surgery leading to impaired drug absorption
- Currently using gastrointestinal medications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
- Bausch Health Americas, Inc.collaborator
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme Corp.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2008
First Posted
October 2, 2008
Study Start
May 1, 2008
Primary Completion
August 1, 2008
Study Completion
August 1, 2008
Last Updated
March 11, 2015
Results First Posted
April 30, 2010
Record last verified: 2015-02