A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® (CL2007-17 )(P07813)(COMPLETED)
Randomized, Crossover Pharmacodynamic Study Comparing the Effects of Zegerid® (20 mg Omeprazole/Sodium Bicarbonate) and Prilosec OTC® (20 Mg-equivalent Omeprazole)
3 other identifiers
interventional
60
0 countries
N/A
Brief Summary
Open-label randomized crossover design studies. 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. The other 30 participants will receive a single administration of sodium bicarbonate.
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 Apr 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
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 2, 2008
CompletedFirst Posted
Study publicly available on registry
May 7, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedResults Posted
Study results publicly available
April 30, 2010
CompletedMarch 11, 2015
February 1, 2015
2 months
May 2, 2008
September 17, 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. 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.
Baseline and 7 days
Study Arms (3)
Single Dose Zegerid for 1 or 7 days
EXPERIMENTALOmeprazole 20 mg/Sodium Bicarbonate 1680 mg Powder for Oral Suspension
Single Dose Prilosec 1 or 7 days
ACTIVE COMPARATOROmeprazole magnesium 20 mg over-the-counter (OTC) Tablet
Sodium Bicarbonate
ACTIVE COMPARATORSodium Bicarbonate 1680 mg Oral Suspension
Interventions
Omeprazole/sodium bicarbonate. Single dose per day for either 1 or 7 days.
Omeprazole 20 mg tablet. Single dose 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
May 2, 2008
First Posted
May 7, 2008
Study Start
April 1, 2008
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
March 11, 2015
Results First Posted
April 30, 2010
Record last verified: 2015-02