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Pharmacodynamic Study Comparing the Effects of Two Different Forms of Omeprazole (P07812) (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: NCT01077076
Recruitment Status : Completed
First Posted : February 26, 2010
Results First Posted : April 2, 2010
Last Update Posted : March 11, 2015
Information provided by (Responsible Party):

Brief Summary:

This randomized, crossover study is to evaluate the early effectiveness, defined as effect on intragastric pH during the first 4 hours after dosing, of Zegerid, Prilosec over-the-counter (OTC) Tablets, and placebo on the 4th day of treatment to inhibit acid secretion. Additional purposes are to:

  1. provide pharmacodynamic evidence comparing 24-hr inhibition of acid secretion on the 1st, 4th, and 11th days of dosing with each of the indicated treatments;
  2. compare Zegerid and Prilosec OTC for achieving their steady-state effects for controlling 24-hr gastric acidity at steady-state on the 4th and 11th day of dosing.
  3. evaluate early effectiveness, defined as effect on intragastric pH during the first 4 hours after administration, of Zegerid, Prilosec OTC Tablets, and placebo on acid inhibition at steady-state when administered on the 11th day of dosing.

Condition or disease Intervention/treatment Phase
Intragastric Acidity Drug: Zegerid Drug: Prilosec OTC™ Tablets Other: Placebo Phase 3

Detailed Description:
Participants were randomized in a 3-way crossover design and received, in random order, Zegerid OTC Capsules (20 mg omeprazole and 1100 mg sodium bicarbonate), Prilosec OTC Tablets (20 mg-equivalent omeprazole), and Placebo Capsules. Participants received each treatment for 11 days. There was a minimum of a 2-week washout period between treatment arms.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Randomized, Placebo-Controlled, Crossover Pharmacodynamic Study Comparing the Effects of Two Different Forms of Omeprazole
Study Start Date : December 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Zegerid OTC Capsules
20 mg omeprazole and 1100 mg sodium bicarbonate
Drug: Zegerid
Zegerid taken once daily for 11 days.

Active Comparator: Prilosec OTC™ tablets containing 20 mg-equivalent omeprazole
20.6 mg omeprazole-magnesium complex.
Drug: Prilosec OTC™ Tablets
Prilosec OTC™ Tablets taken once daily for 11 days.

Placebo Comparator: Placebo
Inert substance
Other: Placebo
Placebo taken once daily for 11 days.

Primary Outcome Measures :
  1. Percent Time With Intragastric pH>4 During the First 4 Hours Following Administration on Day 4 of Treatment [ Time Frame: 4 hours after dose on Day 4 ]
    Early effectiveness of treatment is evaluated as the percent time with intragastric pH>4 during the first 4 hours following administration of respective treatments

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:

  • Male or non-lactating, non-pregnant female subjects who are 18-65 years of age.
  • Physical examination findings within normal limits for age.

Exclusion Criteria:

  • History of hypersensitivity, allergy or intolerance to omeprazole, or other proton pump inhibitors
  • History of peptic ulcer disease or other acid related gastrointestinal symptoms or heartburn with a frequency of more than one/month.
  • Participation in any study of an investigational treatment in the 30 Days before Screening or participation in another study at any time during the period of this study
  • Any significant medical illness that would contraindicate participation in the study
  • Gastrointestinal disorder or surgery leading to impaired drug absorption
  • Any abnormal Screening laboratory value that is clinically significant in the investigator's opinion
  • Current use of any prescription or OTC medications that affect gastrointestinal function.
  • Currently using or having a history of frequent use of antacids, OTC or prescription (Rx) histamine-2 (H2) receptor antagonists, or OTC or Rx use of proton pump inhibitors.
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Responsible Party: Bayer Identifier: NCT01077076    
Other Study ID Numbers: 18132
P07812 ( Other Identifier: Merck )
First Posted: February 26, 2010    Key Record Dates
Results First Posted: April 2, 2010
Last Update Posted: March 11, 2015
Last Verified: February 2015
Keywords provided by Bayer:
Gastric Acid
Human Experimentation
Additional relevant MeSH terms:
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Omeprazole, sodium bicarbonate drug combination
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action