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

NCT ID: NCT02724150

Last Updated: 2018-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2021-07-31

Brief Summary

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

Detailed Description

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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

Conditions

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Gastroduodenal Ulcer Marginal Ulcer Peptic Ulcer Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Omeprazole High dose

Omeprazole 80 mg loading dose,then 8mg/h IV continuous infusion for 3 days

Group Type ACTIVE_COMPARATOR

Omeprazole High dose

Intervention Type DRUG

High regimen of Proton Pump Inhibitors in treatment of bleeding ulcer 80 mg loading dose then 8 mg/h iv for 3 days

Omeprazole Low Dose

Omeprazole 80 mg loading dose IV then 40 mg two times per day IV for 3 days

Group Type EXPERIMENTAL

Omeprazole Low dose

Intervention Type DRUG

low regimen of Proton Pump Inhibitors in treatment bleeding ulcer 80 mg loading dose then 40 mg two times per day for 3 days

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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....
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Damascus Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marouf Alhalabi, MD

Role: PRINCIPAL_INVESTIGATOR

Damascus Hospital

Locations

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Damascus Hospital

Damascus, , Syria

Site Status

Countries

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Syria

Other Identifiers

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G2

Identifier Type: -

Identifier Source: org_study_id

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