Conditions: Bleeding Peptic Ulcer
Keywords: peptic ulcer bleeding prevention of rebleeding successful endoscopic haemostatic therapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 239
Healthy volunteers: no

Brief 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

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Esomeprazole Na intervention 2: Cimetidine intervention 3: Esomeprazole Mg
Intervention descriptions: intervention 1: Given as 80mg bolus infusion during 30 min and then 8mg/h constant infusion during 71.5 hous intervention 2: Given as 200mg bolus infusion during 30 min and then 60mg/h constant infusion during 71.5 hours intervention 3: 40 mg tablet once daily for 27 days

Protocol document: