Study of 24-hour Intragastric pH Profiles of Esomeprazole 40 mg and Lansoprazole 30 mg in Healthy Volunteer Subjects

A Randomized, Open-Label, Comparative, Two-Treatment, Crossover Study of 24-hour Intragastric pH Profiles of Esomeprazole 40 mg and Lansoprazole 30 mg in Healthy Volunteer Subjects on Days 1 and 5 of Intravenous Treatment

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00230516

Enrollment

100

Registered

2005-10-03

Start date

2005-09-30

Completion date

2006-02-28

Last updated

2013-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

N/A this study is being conducted with healthy volunteers

Brief summary

This study is intended to evaluate whether intravenous (iv) esomeprazole (Nexium® ) offers better intragastric acid suppression than iv lansoprazole (Prevacid ®

Interventions

DRUGNexium

DRUGPrevacid

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

* Participants must be 18-70 years of age * Participants can be male or female * Women that are able to have children must have a negative pregnancy test.

Exclusion criteria

* Involvement in or planning of this study * Participation in another clinical study within 28 days of this one * For women, pregnancy or attempting to become pregnant.

Design outcomes

Primary

Measure	Time frame
The primary objective is to compare the pharmacodynamic efficacy in controlling intragastric pH of esomeprazole 40mg and lansoprazole 30mg on Day 5 of once daily IV administration to healthy volunteers.	—

Secondary

Measure	Time frame
Secondary Outcomes will compare additional efficacy and safety parameters.	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026