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Different Dose of Intravenous Omeprazole to Treat Bleeding Ulcer With Adherent Clot

Primary Purpose

Peptic Ulcer, Hemorrhage

Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
omeprazole
omeprazole
Sponsored by
Far Eastern Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peptic Ulcer focused on measuring peptic ulcer bleeding, blood clot, dose

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • We will include those patients with adherent clot, more than 5 mm, on gastric or duodenal ulcers after endoscopic confirmation and exclusion of other possible bleeder. Adherent clot is defined that still stays on the ulcer after 200 ml normal saline irrigation (4 times of irrigation with 50 ml syringe).

Exclusion Criteria:

  • ulcer with active bleeding, suspected malignant ulcer, patients with age less than 18 years old, or allergy to omeprazole

Sites / Locations

  • Far Eastern Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

receive high dose PPI treament with intravenous omeprazole 80 mg stat and then 8mg/hr infusion for 3 days

receive usual dose PPI treatment with ntravenous omeprazole 40 mg stat and then 40 mg q12h for 3 days

Outcomes

Primary Outcome Measures

rebleeding rate within 30 days after allocation

Secondary Outcome Measures

blood transfusion units needed within 30 days after allocation

Full Information

First Posted
February 6, 2009
Last Updated
February 5, 2016
Sponsor
Far Eastern Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02536989
Brief Title
Different Dose of Intravenous Omeprazole to Treat Bleeding Ulcer With Adherent Clot
Official Title
Comparison of High Dose Infusion and Low Dose Bolus Intravenous Omeprazole for Treatment of Bleeding Ulcer With Adherent Clot
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Far Eastern Memorial Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The investigators will include those patients with adherent clot on gastric or duodenal ulcers after endoscopic confirmation After receiving well explanation and giving written consent, they are enrolled and will be allocated to 2 groups randomly. Those in the first group will receive intravenous omeprazole 40 mg stat and then 40 mg q12h. Those in the second group will receive intravenous omeprazole 80 mg stat and then 8mg/hr infusion. The patients in both groups will receive intravenous omeprazole for 3 days and then oral esomeprazole qd for further treatment of peptic ulcer. The investigators define rebleeding during admission and within 30 days as primary end points and define surgical intervention for ulcer bleeding, transfusion amount and hospitalization days after allocation as secondary end points.
Detailed Description
The investigators will include those patients with adherent clot on gastric or duodenal ulcers after endoscopic confirmation and exclusion of other possible bleeder. Adherent clot is defined that still stays on the ulcer after 200 ml normal saline irrigation (4 times of irrigation with 50 ml syringe). After receiving well explanation and giving written consent, they are enrolled and will be allocated to 2 groups randomly. Those in the first group will receive intravenous omeprazole 40 mg stat and then 40 mg q12h. Those in the second group will receive intravenous omeprazole 80 mg stat and then 8mg/hr infusion. The patients in both groups will receive intravenous omeprazole for 3 days and then oral esomeprazole qd for further treatment of peptic ulcer. The investigators will record the basic data of these patients including age, sex, use of NSAID or anit-coagulant, concomitant major diseases; clinical data including Hb, Plt, PT, the lowest systolic pressure before allocation and heart rate at the same time, shock status, transfusion amount before allocation; endoscopic findings including the location & size of ulcer, size of clot, existence of fresh blood in stomach or duodenum. The investigators will monitor the events of rebleeding during admission and within 30 days, surgery for ulcer bleeding and mortality within 30 days and record the amount of transfusion and hospitalization days after allocation. When rebleeding is suspected , those patient will receive endoscopic examination and appropriate therapy. Further treatment with surgical or angiographic intervention is decided by the attending physicians.These patients will be monitored during admission (2 weeks in average)and then followed up in GI outpatient clinics. The investigators define rebleeding during admission and within 30 days as primary end points. Rebleeding is defined as the one of the clinical manifestations occurring 6 hours after allocation: 1.hematemesis or bloody stool 2. tarry stool and hemodynamic change (systolic pressure less than 90 mmHg, or heart more than 110 beats per minute ) 3. decrease of Hb more than 2g/dl within 24 hours after elevation of Hb to 10 g/dl with transfusion. The investigators define surgical intervention for ulcer bleeding, transfusion amount and hospitalization days after allocation as secondary end points.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peptic Ulcer, Hemorrhage
Keywords
peptic ulcer bleeding, blood clot, dose

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
receive high dose PPI treament with intravenous omeprazole 80 mg stat and then 8mg/hr infusion for 3 days
Arm Title
2
Arm Type
Active Comparator
Arm Description
receive usual dose PPI treatment with ntravenous omeprazole 40 mg stat and then 40 mg q12h for 3 days
Intervention Type
Drug
Intervention Name(s)
omeprazole
Other Intervention Name(s)
Losec, iv, high dose
Intervention Description
receive intravenous omeprazole 80 mg stat and then 8mg/hr infusion for 3 days
Intervention Type
Drug
Intervention Name(s)
omeprazole
Other Intervention Name(s)
Losec, iv, usual dose
Intervention Description
receive intravenous omeprazole 40 mg stat and then 40 mg q12h for 3 days
Primary Outcome Measure Information:
Title
rebleeding rate within 30 days after allocation
Time Frame
within 30 days after allocation
Secondary Outcome Measure Information:
Title
blood transfusion units needed within 30 days after allocation
Time Frame
within 30 days after allocation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: We will include those patients with adherent clot, more than 5 mm, on gastric or duodenal ulcers after endoscopic confirmation and exclusion of other possible bleeder. Adherent clot is defined that still stays on the ulcer after 200 ml normal saline irrigation (4 times of irrigation with 50 ml syringe). Exclusion Criteria: ulcer with active bleeding, suspected malignant ulcer, patients with age less than 18 years old, or allergy to omeprazole
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tzong-Hsi Lee, M.D.
Organizational Affiliation
Far Eastern Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Far Eastern Memorial Hospital
City
Taipei
ZIP/Postal Code
22050
Country
Taiwan

12. IPD Sharing Statement

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Different Dose of Intravenous Omeprazole to Treat Bleeding Ulcer With Adherent Clot

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