Comparison of Prilosec OTC® Versus Zegerid® for Gastric Acid Suppression

NCT00808769 | Completed Phase 4 Results

• 1 other identifier: 2008122
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare Prilosec OTC® and Zegerid® in their effects on gastric acid suppression.

Conditions

Normal Healthy Subject Population

Outcome Measures

Primary Outcomes (1)

• The Mean Percent Time Gastric pH > 4.0 on Day 1

  In this study, there was evidence of gastric pH probe failure and a high incidence of biologically improbable pH measurements (sustained pH \< 1.0) that bring the validity of the results into question. The results of this study are, therefore, inconclusive.

  continuously over a 24 hour period

Study Arms (2)

1

ACTIVE COMPARATOR

Zegerid®

Drug: Zegerid®

2

EXPERIMENTAL

Prilosec OTC®

Drug: Prilosec OTC®

Interventions

Zegerid® DRUG

capsule(20 mg omeprazole/sodium bicarbonate), single dose

1

Prilosec OTC® DRUG

Omeprazole-magnesium 20.6 mg, tablet, single dose

2

Eligibility Criteria

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

You may qualify if:

• Normal subjects who are 18-65 years of age;
• Non-childbearing potential females or those using birth control

You may not qualify if:

• History of significant GI disease
• Any significant medical illness
• History of hypersensitivity, allergy or intolerance to omeprazole or other proton pump inhibitors;
• Currently using GI medications
• GI disorder or surgery leading to impaired drug absorption

Sponsors & Collaborators

• Procter and Gamble: lead

Study Sites (1)

Research Site

Oklahoma City, Oklahoma, 73104, United States

Location

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

Limitations and Caveats

Results of this study were uninterpretable as noted in the Analysis Population Description.

Results Point of Contact

• Title: John Mcrorie, PhD, FACG, AGAF
• Organization: The Procter & Gamble Company

mcrorie.jw@pg.com

513-622-1423

Study Officials

• John McRorie, PhD, FACG, AGAF

  Procter and Gamble

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2008
• First Posted: December 16, 2008
• Study Start: November 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: June 1, 2015
• Results First Posted: April 27, 2011

Record last verified: 2015-05

Locations

US (1)