drugset / Trial / NCT00251979

A Study to Prevent Rebleeding After Initial Successful Primary Endoscopic Haemostasis of a Bleeding Peptic Ulcer

NCT00251979 ↗

Phase 3 Completed 1312 enrolled AstraZeneca
RandomizedParallel-groupDouble-blindPrevention

Summary

This study is being carried out to see if constant 3 days infusion of Nexium is effective in preventing rebleeding after an endoscopic treatment.

Timeline

Start
2005-10
Primary completion
2007-12
Completion
2007-12

Outcome

Met primary endpoint

paper Fewer patients receiving intravenous esomeprazole (22 of 375) had recurrent bleeding within 72 hours than those receiving placebo (40 of 389) PMID 19221370 ↗

paper (5.9% vs. 10.3%; difference, 4.4 percentage points [95% CI, 0.6% to 8.3%]; P = 0.026). PMID 19221370 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Esomeprazole Small molecule 8 mg Intravenous
Subject Esomeprazole Small molecule 40 mg Intravenous

Indications

No indication recorded.