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

NCT ID: NCT01275937

Last Updated: 2011-08-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2014-01-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Esomeprazole

Esomeprazole 40 mg IV daily is given for three days followed by40mg once daily orally for two months.

Group Type: OTHER

Esomeprazole

Intervention Type: DRUG

Esomeprazole 40 mg IV daily is given for three days. Thereafter, the patients receive 40 mg Esomeprazole orally daily for two months.

esomeprazole

esomeprazole 160 mg/day continuous infusion is given for three days followed by 40mg once daily orally for two months.

Group Type: ACTIVE_COMPARATOR

Esomeprazole

Intervention Type: DRUG

Esomeprazole 40 mg IV daily is given for three days. Thereafter, the patients receive 40 mg Esomeprazole orally daily for two months.

esomeprazole

Intervention Type: DRUG

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

Interventions

Esomeprazole

Esomeprazole 40 mg IV daily is given for three days. Thereafter, the patients receive 40 mg Esomeprazole orally daily for two months.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

nexium

Eligibility Criteria

Inclusion Criteria

• a peptic with active bleeding, a non-bleeding visible vessel or an adherent blood clot at the ulcer base is observed within24 hours of hospital admission

Exclusion Criteria

• Patients are excluded from the study if they are pregnant, do not obtain initial hemostasis with endoscopic injection epinephrine, do not give written informed consent,have bleeding tendency(platelet count <50*109/L,serum prothrombin <30% of normal, or were taking anticoagulants), uremia

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Taipei Medical University

Principal Investigators

Hwai-jeng Lin, MD

Role: STUDY_CHAIR

Taipei Medical University

Locations

Taipei Medical University Hospital

Taipei, Taiwan, Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Hwai-jeng Lin, Doctor

Role: CONTACT

buddhistlearning@gmail.com

886-2-27372181

Facility Contacts

Hwai-jeng Lin, M.D.

Role: primary

buddhistlearning@gmail.com

886-2-27372181 ext. 3040

Other Identifiers

TMUH-2011

Identifier Type: -

Identifier Source: org_study_id