A Double Blind Study Comparing Two Doses of IV Esomeprazole After Successful Endoscopic Therapy
Status:
Unknown status
Trial end date:
2014-01-01
Target enrollment:
Participant gender:
Summary
A bleeding peptic ulcer remains a serious medical problem with significant morbidity and
mortality. Endoscopic therapy significantly reduces further bleeding, surgery, and mortality
in patients with bleeding peptic ulcers and is now recommended as the first hemostatic
modality for these patients.
In the past few years, adjuvant use of a high-dose proton pump inhibitor (PPI) after
endoscopic therapy has been endorsed in some studies. However, low dose of PPI has also been
supported in the management of these patients.
The investigators enroll 130 patients with active bleeding or nonbleeding visible vessels in
this study. They are randomly assigned as 40 mg/day or 160mg/day IV nexium group. All
patients receive successful endoscopic therapy with heater probe or hemoclip placement.
In the low dose group (N=65), 40 mg IV Nexium daily is given for three days. Thereafter, the
patients receive 40 mg nexium orally daily for two months. In the large dose group (N=65),
160 mg/day continuous infusion is given for three days. Thereafter, the patients receive 40
mg nexium orally daily for two months.
The primary end point is recurrent bleeding before discharge and within 14 days. At day 14,
volume of blood transfused, number of surgeries performed, and the mortality rates of the two
groups are compared as well.