Comparison of Low Against High Regimen of Proton Pump Inhibitors for Treatment of Acute Peptic Ulcer Bleeding

July 7, 2018 updated by: Damascus Hospital

Low Dose Against High Dose of Proton Pump Inhibitors in Treatment Acute Peptic Ulcer Bleeding

Evaluate the efficacy of Two different regimens of proton pump inhibitors High against Low in the management of acute peptic ulcer bleeding

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Evaluate the efficacy of Two different regimens of proton pump inhibitors in the management of acute peptic ulcer bleeding First: loading dose 80 mg then 8mg/h iv continuous infusion for 3 days Second Loading dose 80 mg the 40 mg every 12 h for 3 days

Study Type

Interventional

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

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • High risk ulcers defined according to the Forrest classification With respect to high-risk stigmata,
  • active bleeding was defined as a continuous blood spurting (Forrest IA)
  • oozing (Forrest IB) from the ulcer base.
  • A non-bleeding visible vessel at endoscopy was defined as a discrete protuberance at the ulcer base(Forrest IIA).
  • An adherent clot was one that was resistant to forceful irrigation or suction (Forrest IIB).

Exclusion Criteria:

  • ulcer was malignant
  • non ulcerative bleeding such as angiodysplasia , a Mallory-Weiss tear....

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Omeprazole High dose
Omeprazole 80 mg loading dose,then 8mg/h IV continuous infusion for 3 days
Drug: Omeprazole High dose
High regimen of Proton Pump Inhibitors in treatment of bleeding ulcer 80 mg loading dose then 8 mg/h iv for 3 days
Experimental: Omeprazole Low Dose
Omeprazole 80 mg loading dose IV then 40 mg two times per day IV for 3 days
Drug: Omeprazole Low dose
low regimen of Proton Pump Inhibitors in treatment bleeding ulcer 80 mg loading dose then 40 mg two times per day for 3 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: 1 month
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rebleeding
Time Frame: one month
recurrent melena (black, tarry stool) or recurrent Hematemesis or coffee-ground emesis or recurrent hematochezia after begin treatment
one month
Surgery
Time Frame: one month
need for surgery
one month
Length of hospital stay
Time Frame: one month
one month
Blood transfusions
Time Frame: one month
number of transfusion blood unites during admission
one month

Collaborators and Investigators

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

Sponsor

Damascus Hospital

Investigators

  • Principal Investigator: Marouf Alhalabi, MD, Damascus Hospital

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 (Actual)

December 1, 2017

Primary Completion (Anticipated)

February 1, 2021

Study Completion (Anticipated)

July 1, 2021

Study Registration Dates

First Submitted

March 14, 2016

First Submitted That Met QC Criteria

March 26, 2016

First Posted (Estimate)

March 31, 2016

Study Record Updates

Last Update Posted (Actual)

July 10, 2018

Last Update Submitted That Met QC Criteria

July 7, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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