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Comparing Two Doses of IV Esomeprazole After Successful Endoscopic Therapy (lowdosePPI)

Primary Purpose

Peptic Ulcer Bleeding

Status
Withdrawn
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
heat probe or hemoclip
heat probe or hemoclip
Sponsored by
Changhua Christian Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peptic Ulcer Bleeding focused on measuring hemostasis, heat probe, hemoclip, rebleeding

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients with peptic ulcer bleeding with active bleeding or nonbleeding visible (initial Hb<10, shock, or coffee grounds or blood in stomach)

Exclusion Criteria:

  • age >90y/o
  • pregnant woman
  • allergic to esomeprazole
  • unwilling to enter this study
  • bleeding tendency
  • severe co-morbid illness, including cancer, hepatic failure, renal failure,

Sites / Locations

  • Division of Gastroenterology, TMUH

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

low dose PPI

high dose PPI

Arm Description

40 mg esomeprazole IV for three days followed by esomeprazole 40 mg po daily for two months

40 mg esomeprazole IV every 6 hr for 3 days followed by 40 mg po daily for two months

Outcomes

Primary Outcome Measures

further bleeding
Number of participants with rebleeding within 14 days

Secondary Outcome Measures

hospital stay
hospital stay in day
need of blood transfusion
number of participants need of blood transufion
surgical intervention
number of participants need surgical intervention to manage bleeding
mortality
number of participants death

Full Information

First Posted
August 4, 2011
Last Updated
May 27, 2020
Sponsor
Changhua Christian Hospital
Collaborators
Taipei Medical University Hospital, Dalin Tzu Chi General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04407832
Brief Title
Comparing Two Doses of IV Esomeprazole After Successful Endoscopic Therapy
Acronym
lowdosePPI
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
May 2020
Overall Recruitment Status
Withdrawn
Study Start Date
August 2011 (undefined)
Primary Completion Date
July 2013 (Anticipated)
Study Completion Date
September 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Changhua Christian Hospital
Collaborators
Taipei Medical University Hospital, Dalin Tzu Chi General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The investigators used two different doses of esomeprazole (40 mg IV q.d. and 40 mg IV q6h for three days followed by esomeprazole 40 mg q.d. orally in two groups) after successful endoscopic therapy with heat probe therapy or hemoclip placement. The goal of this study is to assess the outcomes of two different regimens of low vs. high dose of intravenous esomeprazole after endoscopic therapy in patients with peptic ulcer bleeding.
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 receiving intravenous Proton Pump Inhibitor (PPI）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, including two consensus statements and two meta-analysis. To sustain a high intragastric pH, a high dose of omeprazole has been used in previous studies concerning high-risk peptic ulcer bleeding. However, in one recent published metaanalysis found that low dose PPI may be as effective as high dose PPI in preventing further bleeding in high-risk patients. Therefore, one double blind study is needed clarify this puzzle. We used two different doses of esomeprazole (40 mg IV q.d. and 40 mg IV q6h for three days followed by esomeprazole 40 mg q.d. orally in two groups) after successful endoscopic therapy with heat probe therapy or hemoclip placement. The goal of this study is to assess the outcomes of two different regimens of low vs. high dose of intravenous esomeprazole after endoscopic therapy in patients with peptic ulcer bleeding.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peptic Ulcer Bleeding
Keywords
hemostasis, heat probe, hemoclip, rebleeding

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
low dose PPI
Arm Type
Active Comparator
Arm Description
40 mg esomeprazole IV for three days followed by esomeprazole 40 mg po daily for two months
Arm Title
high dose PPI
Arm Type
Active Comparator
Arm Description
40 mg esomeprazole IV every 6 hr for 3 days followed by 40 mg po daily for two months
Intervention Type
Device
Intervention Name(s)
heat probe or hemoclip
Other Intervention Name(s)
Olympus co.
Intervention Description
for hemostasis
Intervention Type
Device
Intervention Name(s)
heat probe or hemoclip
Other Intervention Name(s)
Olympus co.
Intervention Description
for hemostasis
Primary Outcome Measure Information:
Title
further bleeding
Description
Number of participants with rebleeding within 14 days
Time Frame
14 days
Secondary Outcome Measure Information:
Title
hospital stay
Description
hospital stay in day
Time Frame
30 days
Title
need of blood transfusion
Description
number of participants need of blood transufion
Time Frame
30 days
Title
surgical intervention
Description
number of participants need surgical intervention to manage bleeding
Time Frame
30 days
Title
mortality
Description
number of participants death
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients with peptic ulcer bleeding with active bleeding or nonbleeding visible (initial Hb<10, shock, or coffee grounds or blood in stomach) Exclusion Criteria: age >90y/o pregnant woman allergic to esomeprazole unwilling to enter this study bleeding tendency severe co-morbid illness, including cancer, hepatic failure, renal failure,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hwai-jeng Lin, M.D.
Organizational Affiliation
Taipei Medical University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Gastroenterology, TMUH
City
Taipei
ZIP/Postal Code
110
Country
Taiwan

12. IPD Sharing Statement

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Comparing Two Doses of IV Esomeprazole After Successful Endoscopic Therapy

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