NCT00230516

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for phase_4 healthy

Timeline
Completed

Started Sep 2005

Shorter than P25 for phase_4 healthy

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

September 28, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 3, 2005

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

January 4, 2013

Status Verified

January 1, 2013

First QC Date

September 28, 2005

Last Update Submit

January 3, 2013

Conditions

Healthy

Keywords

N/A this study is being conducted with healthy volunteers

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Secondary Outcomes will compare additional efficacy and safety parameters.

Interventions

NexiumDRUG
PrevacidDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Research Site

Los Angeles, California, United States

Location

Research Site

Oklahoma City, Oklahoma, United States

Location

MeSH Terms

Interventions

EsomeprazoleLansoprazole

Intervention Hierarchy (Ancestors)

Omeprazole2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Nexium Medical Science Director, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 28, 2005

First Posted

October 3, 2005

Study Start

September 1, 2005

Study Completion

February 1, 2006

Last Updated

January 4, 2013

Record last verified: 2013-01

Locations

US(2)