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

Primary Purpose

Upper Gastrointestinal Bleeding

Status
Unknown status
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Esomeprazole
esomeprazole
Sponsored by
Taipei Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Upper Gastrointestinal Bleeding

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Taipei Medical University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

Esomeprazole

esomeprazole

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 12, 2011
Last Updated
August 11, 2011
Sponsor
Taipei Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01275937
Brief Title
A Double Blind Study Comparing Two Doses of IV Esomeprazole After Successful Endoscopic Therapy
Official Title
A Double Blind Study Comparing Low Dose and High Dose IV Esomeprazole After Successful Endoscopic Therapy in Patients With Peptic Ulcer Bleeding
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
January 2014 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Taipei Medical University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Gastrointestinal Bleeding

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
65 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Esomeprazole
Arm Type
Other
Arm Description
Esomeprazole 40 mg IV daily is given for three days followed by40mg once daily orally for two months.
Arm Title
esomeprazole
Arm Type
Active Comparator
Arm Description
esomeprazole 160 mg/day continuous infusion is given for three days followed by 40mg once daily orally for two months.
Intervention Type
Drug
Intervention Name(s)
Esomeprazole
Intervention Description
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
Intervention Name(s)
esomeprazole
Other Intervention Name(s)
nexium
Intervention Description
esomeprazole 160 mg/day continuous infusion is given for three days. Thereafter, the patients receive 40 mg nexium orally daily for two months.
Primary Outcome Measure Information:
Title
Two different doses intravenous proton pump inhibitors in patients with peptic ulcer bleeding after successful endoscopic therapy- a prospective randomized comparative trial.
Description
recurrent bleeding before discharge and within 14 days
Time Frame
two years
Secondary Outcome Measure Information:
Title
Two different doses intravenous proton pump inhibitors in patients with peptic ulcer bleeding after successful endoscopic therapy- a prospective randomized comparative trial.
Time Frame
two years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hwai-jeng Lin, Doctor
Phone
886-2-27372181
Email
buddhistlearning@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hwai-jeng Lin, MD
Organizational Affiliation
Taipei Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Taipei Medical University Hospital
City
Taipei
ZIP/Postal Code
110
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hwai-jeng Lin, M.D.
Phone
886-2-27372181
Ext
3040
Email
buddhistlearning@gmail.com
First Name & Middle Initial & Last Name & Degree
Hwai-jeng Lin, M.D.

12. IPD Sharing Statement

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

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