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

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.

Study Overview

• Status: Unknown
• Conditions: Upper Gastrointestinal Bleeding
• Intervention / Treatment: Drug: Esomeprazole; Drug: esomeprazole

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.

• Study Type: Interventional
• Enrollment (Anticipated): 65
• Phase: Phase 4

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 110
    • Recruiting
    • Taipei Medical University Hospital
    • Contact: Hwai-jeng Lin, M.D.; Phone Number: 3040 886-2-27372181; Email: buddhistlearning@gmail.com
    • Principal Investigator: Hwai-jeng Lin, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Esomeprazole; Esomeprazole 40 mg IV daily is given for three days followed by40mg once daily orally for two months.	Drug: Esomeprazole; Esomeprazole 40 mg IV daily is given for three days. Thereafter, the patients receive 40 mg Esomeprazole orally daily for two months.
ACTIVE_COMPARATOR: esomeprazole; esomeprazole 160 mg/day continuous infusion is given for three days followed by 40mg once daily orally for two months.	Drug: Esomeprazole; Esomeprazole 40 mg IV daily is given for three days. Thereafter, the patients receive 40 mg Esomeprazole orally daily for two months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Two different doses intravenous proton pump inhibitors in patients with peptic ulcer bleeding after successful endoscopic therapy- a prospective randomized comparative trial.	recurrent bleeding before discharge and within 14 days	two years

Secondary Outcome Measures

Outcome Measure	Time Frame
Two different doses intravenous proton pump inhibitors in patients with peptic ulcer bleeding after successful endoscopic therapy- a prospective randomized comparative trial.	two years

Collaborators and Investigators

• Sponsor: Taipei Medical University
• Investigators: Study Chair: Hwai-jeng Lin, MD, Taipei Medical University

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (ANTICIPATED): December 1, 2013
• Study Completion (ANTICIPATED): January 1, 2014

Study Registration Dates

• First Submitted: January 12, 2011
• First Submitted That Met QC Criteria: January 12, 2011
• First Posted (ESTIMATE): January 13, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): August 12, 2011
• Last Update Submitted That Met QC Criteria: August 11, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Hemorrhage; Gastrointestinal Hemorrhage; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Esomeprazole
• Other Study ID Numbers: TMUH-2011