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

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ClinicalTrials.gov Identifier: NCT00674115
Recruitment Status : Completed
First Posted : May 7, 2008
Results First Posted : April 30, 2010
Last Update Posted : March 11, 2015
Sponsor:
Collaborator:
Bausch Health Americas, Inc.
Information provided by (Responsible Party):
Bayer

Study Description
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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.

Condition or disease Intervention/treatment Phase
Gastric Acid Human Experimentation Drug: Omeprazole/sodium bicarbonate Drug: omeprazole magnesium Drug: sodium bicarbonate 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 2-way crossover design with an added third period. These participants received single administrations (day 1 dosing only) of Zegerid Powder for Oral Suspension, and Prilosec OTC (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. Following completion of the 2-way crossover study, and a subsequent washout period (minimum of 2 weeks), all participants then received a single administration of sodium bicarbonate (at same dose as contained in Zegerid Powder for Oral Suspension) in Period 3. This group underwent a 24-hour intragastric pH study on each of the 3 dosing occasions.

Group 2: This group was randomized into a 2-way crossover design in which they received 7 days administration of Zegerid Powder for Oral Suspension 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 also underwent 24-hour intragastric pH recordings on the days on 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 and Zegerid Powder for Oral Suspension on change in intragastric pH during the subsequent 24-hour period following the first dose.

Study Design
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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® (20 Mg-equivalent Omeprazole)
Study Start Date : April 2008
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Single Dose Zegerid for 1 or 7 days
Omeprazole 20 mg/Sodium Bicarbonate 1680 mg Powder for Oral Suspension
 Drug: Omeprazole/sodium bicarbonate
Omeprazole/sodium bicarbonate. Single dose per day for either 1 or 7 days.
Other Name: Zegerid
Active Comparator: Single Dose Prilosec 1 or 7 days
Omeprazole magnesium 20 mg over-the-counter (OTC) Tablet
 Drug: omeprazole magnesium
Omeprazole 20 mg tablet. Single dose per day for either 1 or 7 days.
Other Name: Prilosec OTC Tablet
Active Comparator: Sodium Bicarbonate
Sodium Bicarbonate 1680 mg Oral Suspension
 Drug: sodium bicarbonate
Sodium bicarbonate. Single dose.


Outcome Measures
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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. 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.


Eligibility Criteria
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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
Criteria

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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00674115    
Other Study ID Numbers: 18133
CL2007-17
P07813 ( Other Identifier: Merck )
First Posted: May 7, 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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Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
 Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action