NCT01275937

A Double Blind Study Comparing Two Doses of IV Esomeprazole After Successful Endoscopic Therapy

A Double Blind Study Comparing Low Dose and High Dose IV Esomeprazole After Successful Endoscopic Therapy in Patients With Peptic Ulcer Bleeding

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 65 (estimated)
• Sponsor: Taipei Medical University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

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. We 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.

Conditions

• Upper Gastrointestinal Bleeding

Interventions

Type	Name	Description
DRUG	Esomeprazole	Esomeprazole 40 mg IV daily is given for three days. Thereafter, the patients receive 40 mg Esomeprazole orally daily for two months.
DRUG	esomeprazole	esomeprazole 160 mg/day continuous infusion is given for three days. Thereafter, the patients receive 40 mg nexium orally daily for two months.

Timeline

• Start date: 2011-08-01
• Primary completion: 2013-12-01
• Completion: 2014-01-01
• First posted: 2011-01-13
• Last updated: 2011-08-12

Locations

1 site across 1 country: Taiwan