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Comparative Efficacy & Safety Study of D961H Versus Placebo for the Prevention of Gastric and Duodenal Ulcers With Low-dose Aspirin

NCT01069939 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 427

Last updated 2012-11-22

Study results available
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Summary

To assess the efficacy of D961H 20 mg once daily (q.d.) versus placebo in continuous treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily Low-dose aspirin therapy by evaluating time from randomisation to occurrence of gastric and/or duodenal ulcers.

Conditions

  • Prevention

Interventions

DRUG

Esomeprazole

20mg, capsule, 72 weeks

DRUG

Placebo

Placebo, capsule, 72 weeks

Sponsors & Collaborators

Principal Investigators

  • Kentaro Sugano, MD, PhD · Jichi Medical University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2011-11-30
Completion
2011-11-30

Countries

  • Japan
  • South Korea
  • Taiwan

Study Locations

More Related Trials

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 NCT01069939 on ClinicalTrials.gov