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

February 5, 2016 updated by: Tzong-Hsi Lee, Far Eastern Memorial Hospital

Comparison of High Dose Infusion and Low Dose Bolus Intravenous Omeprazole for Treatment of Bleeding Ulcer With Adherent Clot

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 22050
        • Far Eastern Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
receive high dose PPI treament with intravenous omeprazole 80 mg stat and then 8mg/hr infusion for 3 days
Drug: omeprazole
receive intravenous omeprazole 80 mg stat and then 8mg/hr infusion for 3 days
Other Names:
  • Losec, iv, high dose
Drug: omeprazole
receive intravenous omeprazole 40 mg stat and then 40 mg q12h for 3 days
Other Names:
  • Losec, iv, usual dose
Active Comparator: 2
receive usual dose PPI treatment with ntravenous omeprazole 40 mg stat and then 40 mg q12h for 3 days
Drug: omeprazole
receive intravenous omeprazole 80 mg stat and then 8mg/hr infusion for 3 days
Other Names:
  • Losec, iv, high dose
Drug: omeprazole
receive intravenous omeprazole 40 mg stat and then 40 mg q12h for 3 days
Other Names:
  • Losec, iv, usual dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
rebleeding rate within 30 days after allocation
Time Frame: within 30 days after allocation
within 30 days after allocation

Secondary Outcome Measures

Outcome Measure
Time Frame
blood transfusion units needed within 30 days after allocation
Time Frame: within 30 days after allocation
within 30 days after allocation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Far Eastern Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

February 6, 2009

First Submitted That Met QC Criteria

August 28, 2015

First Posted (Estimate)

September 1, 2015

Study Record Updates

Last Update Posted (Estimate)

February 8, 2016

Last Update Submitted That Met QC Criteria

February 5, 2016

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FEMH-96-C009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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