drugset / Trial / NCT00164866

Administration of High-Dose Intravenous Proton Pump Inhibitor for Upper Gastrointestinal Bleeding Prior to Endoscopy

NCT00164866 ↗

Phase 4 Completed 638 enrolled Chinese University of Hong Kong
RandomizedParallel-groupDouble-blindTreatment

Summary

To evaluate if intravenous PPI infusion, when administered prior to endoscopy, hastens resolution of bleeding stigmata and thereby facilitates endoscopic examinations and reduces the need for endoscopic treatment. Clot stabilization may itself sustain control of bleeding before endoscopy. These may translate into improved patients'outcome and survival. To determine the therapeutic effect of high-dose PPI infusion in upper gastrointestinal bleeding from causes other than peptic ulcers.

Timeline

Start
2004-02
Primary completion
—
Completion
2005-09

Outcome

Met primary endpoint

paper The need for endoscopic treatment was lower in the omeprazole group than in the placebo group (60 of the 314 patients included in the analysis [19.1%] vs. 90 of 317 patients [28.4%], P=0.007). PMID 17442905 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Omeprazole Other / unclassified 8 mg Intravenous

Indications