Pharmacodynamic Study Comparing the Effects of Two Different Forms of Omeprazole (P07812) (COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01077076
First received: February 25, 2010
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Intragastric Acidity
Drug: Zegerid
Drug: Prilosec OTC™ Tablets
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Randomized, Placebo-Controlled, Crossover Pharmacodynamic Study Comparing the Effects of Two Different Forms of Omeprazole

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Early effectiveness of treatment is evaluated as the percent time with intragastric pH>4 during the first 4 hours following administration of respective treatments


Enrollment: 30
Study Start Date: December 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01077076     History of Changes
Other Study ID Numbers: P07812
Study First Received: February 25, 2010
Results First Received: March 11, 2010
Last Updated: July 15, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Gastric Acid
Human Experimentation

Additional relevant MeSH terms:
Omeprazole
Anti-Ulcer Agents
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Proton Pump Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014