Text Size

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
ClinicalTrials.gov Identifier:
NCT01077076
First received: February 25, 2010
Last updated: June 7, 2013
Last verified: June 2013
History of Changes
  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:

MedlinePlus related topics: Heartburn
U.S. FDA Resources

Further study details as provided by Merck:

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
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT01077076     History of Changes
Other Study ID Numbers: CL2008-16
Study First Received: February 25, 2010
Results First Received: March 11, 2010
Last Updated: June 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck:
Gastric Acid
Human Experimentation

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

ClinicalTrials.gov processed this record on June 18, 2013