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

Peptic Ulcer Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02724150
• Other study ID #: G2
• Status: Withdrawn
• Phase: Phase 4
• Start date: December 1, 2017
• Est. completion date: July 2021

Study information

• Verified date: July 2018
• Source: Damascus Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2021
• Est. primary completion date: February 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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....

Related Conditions & MeSH terms

• Gastroduodenal Ulcer
• Hemorrhage
• Marginal Ulcer
• Peptic Ulcer
• Peptic Ulcer Hemorrhage
• Ulcer

Intervention

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
• 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

Locations

Country	Name	City	State
Syrian Arab Republic	Damascus Hospital	Damascus

Sponsors (1)

Lead Sponsor	Collaborator
Damascus Hospital

Country where clinical trial is conducted

Syrian Arab Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality		1 month
Secondary	Rebleeding	recurrent melena (black, tarry stool) or recurrent Hematemesis or coffee-ground emesis or recurrent hematochezia after begin treatment	one month
Secondary	Surgery	need for surgery	one month
Secondary	Length of hospital stay		one month
Secondary	Blood transfusions	number of transfusion blood unites during admission	one month