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High Dose Esomeprazole Na for Prevention of Rebleeding After Successful Endoscopic Therapy of a Bleeding Peptic Ulcer

NCT01757275 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 239

Last updated 2016-03-08

Study results available
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Summary

To describe the rate of clinically significant rebleeding during 72 hours continuous i.v. infusion of high dose esomeprazole Na in patients in China with primary successful endoscopic haemostatic therapy of a bleeding peptic ulcer, with cimetidine i.v. in

Conditions

  • Bleeding Peptic Ulcer

Interventions

DRUG

Esomeprazole Na

Given as 80mg bolus infusion during 30 min and then 8mg/h constant infusion during 71.5 hous

DRUG

Cimetidine

Given as 200mg bolus infusion during 30 min and then 60mg/h constant infusion during 71.5 hours

DRUG

Esomeprazole Mg

40 mg tablet once daily for 27 days

Sponsors & Collaborators

Principal Investigators

  • Tore Lind, MD · AstraZeneca Molndal, Sweden

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2014-12-31
Completion
2014-12-31

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 NCT01757275 on ClinicalTrials.gov