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

Phase 4

Withdrawn

• Conditions: Gastroduodenal Ulcer; Marginal Ulcer; Peptic Ulcer Hemorrhage
• Interventions: Drug: Omeprazole High dose; Drug: Omeprazole Low dose

• Registration Number: NCT02724150
• Lead Sponsor: Damascus Hospital

Brief Summary

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

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 Timeline

• Study First Submitted: 2016-03-14
• Study First Submitted QC: 2016-03-26
• Study First Posted: 2016-03-31
• Study Start: 2017-12-01
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-07
• Last Update Posted: 2018-07-10
• Primary Completion: 2021-02
• Study Completion: 2021-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Omeprazole High dose	Omeprazole High dose	Omeprazole 80 mg loading dose,then 8mg/h IV continuous infusion for 3 days
Omeprazole Low Dose	Omeprazole Low dose	Omeprazole 80 mg loading dose IV then 40 mg two times per day IV for 3 days

Primary Outcome Measures

Name	Time	Method
Mortality	1 month

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Damascus Hospital; 🇸🇾 Damascus, Syrian Arab Republic