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A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® (CL2007-17 )(P07813)(COMPLETED)

NCT00674115 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2015-03-11

Study results available
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Summary

Open-label randomized crossover design studies. 60 participants will be evaluated on Day 1 to compare effects on stomach acid; 30 participants will continue treatment for 7 days and will have repeat evaluations at Day 7. The other 30 participants will receive a single administration of sodium bicarbonate.

Conditions

  • Gastric Acid
  • Human Experimentation

Interventions

DRUG

Omeprazole/sodium bicarbonate

Omeprazole/sodium bicarbonate. Single dose per day for either 1 or 7 days.

DRUG

omeprazole magnesium

Omeprazole 20 mg tablet. Single dose per day for either 1 or 7 days.

DRUG

sodium bicarbonate

Sodium bicarbonate. Single dose.

Sponsors & Collaborators

  • Bausch Health Americas, Inc.

    collaborator INDUSTRY

  • Bayer

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2008-06-30
Completion
2008-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00674115 on ClinicalTrials.gov