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Stress Ulcer Prophylaxis of Intravenous Esomeprazole in Chinese Seriously Ill Patients

NCT02157376 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 343

Last updated 2017-03-10

Study results available
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Summary

The efficacy of esomeprazole will be compared versus cimetidine (a drug that previously demonstrated prevention of bleeding events) during treatment period in proportion of patients for the prevention of upper GI bleeding.

Conditions

  • Stress Ulcer Prophylaxis

Interventions

DRUG

Esomeprazole

iv esomeprazole 30 min intermittent infusions given for maximum 14 days

DRUG

Cimetidine

iv cimetidine 30 min bolus infusion followed by iv cimetidine continuous infusion given for maximum 14 days

Sponsors & Collaborators

Principal Investigators

  • Xinyu Qin · Professor and Chairman, Department of General Surgery,Zhongshan,Hospital, Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • China

Study Locations

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Entities

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 NCT02157376 on ClinicalTrials.gov