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

NCT01077076 | Completed Phase 3 Results

• 2 other identifiers: 18132P07812
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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. 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. 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. 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.

Conditions

Intragastric Acidity

Keywords

Gastric Acid; Human Experimentation

Outcome Measures

Primary Outcomes (1)

• Percent Time With Intragastric pH>4 During the First 4 Hours Following Administration on Day 4 of Treatment

  Early effectiveness of treatment is evaluated as the percent time with intragastric pH\>4 during the first 4 hours following administration of respective treatments

  4 hours after dose on Day 4

Study Arms (3)

Zegerid OTC Capsules

EXPERIMENTAL

20 mg omeprazole and 1100 mg sodium bicarbonate

Drug: Zegerid

Prilosec OTC™ tablets containing 20 mg-equivalent omeprazole

ACTIVE COMPARATOR

20.6 mg omeprazole-magnesium complex.

Drug: Prilosec OTC™ Tablets

Placebo

PLACEBO COMPARATOR

Inert substance

Other: Placebo

Interventions

Zegerid DRUG

Zegerid taken once daily for 11 days.

Zegerid OTC Capsules

Prilosec OTC™ Tablets DRUG

Prilosec OTC™ Tablets taken once daily for 11 days.

Prilosec OTC™ tablets containing 20 mg-equivalent omeprazole

Placebo OTHER

Placebo taken once daily for 11 days.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

MeSH Terms

Interventions

omeprazole, sodium bicarbonate drug combination; Omeprazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2010
• First Posted: February 26, 2010
• Study Start: December 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: March 11, 2015
• Results First Posted: April 2, 2010

Record last verified: 2015-02