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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00765206
Recruitment Status : Completed
First Posted : October 2, 2008
Results First Posted : April 30, 2010
Last Update Posted : March 11, 2015
Bausch Health Americas, Inc.
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Gastric Acid Human Experimentation Drug: Omeprazole/sodium bicarbonate Drug: omeprazole magnesium (20 mg equivalent) Phase 3

Detailed Description:

Enrolled participants were divided into 2 groups, with 30 participants in each group.

Group 1: This group was randomized into a single-dose, 2-way crossover design. These participants received single administrations (day 1 dosing only) of Zegerid OTC Capsules, and Prilosec OTC Tablets (both at a 20 mg omeprazole dose), in a 2-way randomized order, with a minimum of a 2-week washout period between treatment legs. This group underwent a 24-hour intragastric pH study on each of the 2 dosing occasions.

Group 2: This group was randomized into a 2-way crossover design in which they received 7 days administration of Zegerid OTC Capsules and Prilosec OTC Tablets, respectively. As with the prior group, there was a minimum of a 2-week washout period between treatment legs. Participants assigned to this treatment group underwent 24-hour intragastric pH recordings on the days which they received their 1st and last (7th) dose of the two treatment drugs.

In addition to the above detailed procedures, all participants (both groups) underwent a 24-hour baseline intragastric pH study prior to starting their randomized treatments. This study design enabled all 60 participants to be evaluated for effects of the first dose of Prilosec OTC Tablets and Zegerid OTC Capsules on change in intragastric pH during the subsequent 24-hour period following the first dose.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Randomized, Crossover Pharmacodynamic Study Comparing the Effects of Zegerid® (20 mg Omeprazole/Sodium Bicarbonate) and Prilosec OTC® Tablets (20 Mg-equivalent Omeprazole)
Study Start Date : May 2008
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Zegerid
Omeprazole 20 mg /sodium bicarbonate 1100 mg over-the-counter (OTC) Capsule
Drug: Omeprazole/sodium bicarbonate
Single dose of omeprazole/sodium bicarbonate per day for either 1 or 7 days.
Other Name: Zegerid

Active Comparator: Prilosec
Omeprazole magnesium 20 mg OTC tablet
Drug: omeprazole magnesium (20 mg equivalent)
Single dose of omeprazole magnesium per day for either 1 or 7 days.
Other Name: Prilosec OTC Tablet

Primary Outcome Measures :
  1. Change From Baseline in Median 24-hour Intragastric pH on the 7th Day of Drug Administration [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Normal subjects who are 18-65 years of age.
  • Non-childbearing potential females or those using birth control.

Exclusion Criteria:

  • 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
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Responsible Party: Bayer Identifier: NCT00765206    
Other Study ID Numbers: 18134
P07814 ( Other Identifier: Merck )
First Posted: October 2, 2008    Key Record Dates
Results First Posted: April 30, 2010
Last Update Posted: March 11, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
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Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action