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Study of Esomeprazole 20 mg or 40 mg vs Placebo Effectiveness on the Occurrence of Peptic Ulcers in Subjects on Low Dose Acetylsalicylic Acid (LDA)

NCT00441727 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2426

Last updated 2012-07-16

Study results available
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Summary

The purpose of this study is to compare the effect of esomeprazole 20 or 40 mg once daily versus placebo on the occurrence of peptic ulcers during 26 weeks in subjects on continuous low-dose acetylsalicylic acid.

Conditions

  • Gastric Ulcer
  • Duodenal Ulcer

Interventions

DRUG

Esomeprazole 40 mg

Esomeprazole 40 mg once daily

DRUG

Esomeprazole 20 mg

Esomeprazole 20 mg once daily

DRUG

Placebo

Placebo once daily

Sponsors & Collaborators

Principal Investigators

  • Tore Lind, MD, PhD · AstraZeneca

  • James Scheiman, MD · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2008-08-31
Completion
2008-08-31

Countries

  • United States
  • Argentina
  • Australia
  • Bulgaria
  • Canada
  • Czechia
  • Finland
  • Germany
  • Indonesia
  • Mexico
  • Norway
  • Philippines
  • Poland
  • Portugal
  • Romania
  • Russia
  • Slovakia
  • South Africa
  • South Korea
  • Thailand

Study Locations

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Entities

Drugs
Companies

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 NCT00441727 on ClinicalTrials.gov