Efficacy of Low Dose of Proton Pump Inhibitor in Treatment Bleeding Ulcers

Peptic Ulcer Hemorrhage Clinical Trial

Official title:

Efficacy of Low Dose of Proton Pumb Inhabitor in Treatment Upper Gastrointestinal Bleeding

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03163680
• Other study ID #: G6-17
• Status: Completed
• Start date: January 2012
• Est. completion date: June 4, 2018

Study information

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

Clinical Trial Summary

Determining the efficacy of low dose of PPI in management acute peptic ulcer bleeding

Description:

Determining the efficacy of low dose meaning 40 mg of omeprazole twice in management acute peptic ulcer bleeding

Recruitment information / eligibility

• Status: Completed
• Enrollment: 295
• Est. completion date: June 4, 2018
• Est. primary completion date: May 1, 2018
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Criteria:

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 40 MG
Omperazole 40 mg twice daily

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	Morality	Determination of mortality rate from ulcer bleeding	within 1 week
Secondary	Rebleeding	Determination of the percentage of the return of bleeding represented by recurrent melena (black, tarry stool) or recurrent Hematemesis or coffee-ground emesis or recurrent hematochezia after begin treatment	within 1 week
Secondary	need for surgery	Determine the Surgery rate for treatment Bleeding ulcers within a week	within 1 week
Secondary	Length of hospital stay	Determining the length of stay in the hospital	within 1 month
Secondary	Blood transfusions	number of transfusion blood unites during admission	within 1 week