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

• ClinicalTrials.gov Identifier: NCT01077076
• Recruitment Status: Completed
• First Posted: February 26, 2010
• Results First Posted: April 2, 2010
• Last Update Posted: March 11, 2015
• Sponsor: Bayer
• Information provided by (Responsible Party): Bayer

Study Description

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT01077076
• Other Study ID Numbers: 18132; P07812 ( Other Identifier: Merck )
• First Posted: February 26, 2010
• 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:

Omeprazole; Omeprazole, sodium bicarbonate drug combination; Anti-Ulcer Agents; Gastrointestinal Agents; Proton Pump Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action