NCT01757275

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

A Multi-center, Randomised, Double-blind, Parallel-group Phase III Study to Assess High Dose Esomeprazole Na i.v. Treatment (Bolus Infusion of 80 mg Followed by a Continuous Infusion of 8 mg Per Hour Administered for 72 Hours) for Prevention of Rebleeding

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 239 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Detailed description

A multi-center, randomised, double-blind, parallel-group phase III study to assess high dose esomeprazole Na i.v. treatment (bolus infusion of 80 mg followed by a continuous infusion of 8 mg per hour administered for 72 hours) for prevention of rebleeding

Conditions

• Bleeding Peptic Ulcer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2013-02-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2012-12-28
• Last updated: 2016-03-08
• Results posted: 2016-03-08

Locations

12 sites across 1 country: China