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Completed

NCT Number: NCT01077076

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Zegerid

Drug

Zegerid taken once daily for 11 days.

Prilosec OTC™ Tablets

Drug

Prilosec OTC™ Tablets taken once daily for 11 days.

Placebo

Other

Placebo taken once daily for 11 days.

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Randomized, Placebo-Controlled, Crossover Pharmacodynamic Study Comparing the Effects of Two Different Forms of Omeprazole

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Feb 26, 2010
Registry last updated
Mar 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.