Back to resultsComparison of Low Against High Regimen of Proton Pump Inhibitors for Treatment of Acute Peptic Ulcer Bleeding
Primary Purpose
Gastroduodenal Ulcer, Marginal Ulcer, Peptic Ulcer Hemorrhage
Status
Withdrawn
Phase
Phase 4
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
Omeprazole High dose
Omeprazole Low dose
Sponsored by
About this trial
This is an interventional treatment trial for Gastroduodenal Ulcer focused on measuring Gastroduodenal Ulcer, Marginal Ulcer, Peptic Ulcer Hemorrhage, Peptic Ulcer
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....
Sites / Locations
- Damascus Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Omeprazole High dose
Omeprazole Low Dose
Arm Description
Omeprazole 80 mg loading dose,then 8mg/h IV continuous infusion for 3 days
Omeprazole 80 mg loading dose IV then 40 mg two times per day IV for 3 days
Outcomes
Primary Outcome Measures
Mortality
Secondary Outcome Measures
Rebleeding
recurrent melena (black, tarry stool) or recurrent Hematemesis or coffee-ground emesis or recurrent hematochezia after begin treatment
Surgery
need for surgery
Length of hospital stay
Blood transfusions
number of transfusion blood unites during admission
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02724150
Brief Title
Comparison of Low Against High Regimen of Proton Pump Inhibitors for Treatment of Acute Peptic Ulcer Bleeding
Official Title
Low Dose Against High Dose of Proton Pump Inhibitors in Treatment Acute Peptic Ulcer Bleeding
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Withdrawn
Why Stopped
No participants enrolled
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
February 2021 (Anticipated)
Study Completion Date
July 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damascus Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroduodenal Ulcer, Marginal Ulcer, Peptic Ulcer Hemorrhage
Keywords
Gastroduodenal Ulcer, Marginal Ulcer, Peptic Ulcer Hemorrhage, Peptic Ulcer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Omeprazole High dose
Arm Type
Active Comparator
Arm Description
Omeprazole 80 mg loading dose,then 8mg/h IV continuous infusion for 3 days
Arm Title
Omeprazole Low Dose
Arm Type
Experimental
Arm Description
Omeprazole 80 mg loading dose IV then 40 mg two times per day IV for 3 days
Intervention Type
Drug
Intervention Name(s)
Omeprazole High dose
Intervention Description
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
Intervention Name(s)
Omeprazole Low dose
Intervention Description
low regimen of Proton Pump Inhibitors in treatment bleeding ulcer 80 mg loading dose then 40 mg two times per day for 3 days
Primary Outcome Measure Information:
Title
Mortality
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Rebleeding
Description
recurrent melena (black, tarry stool) or recurrent Hematemesis or coffee-ground emesis or recurrent hematochezia after begin treatment
Time Frame
one month
Title
Surgery
Description
need for surgery
Time Frame
one month
Title
Length of hospital stay
Time Frame
one month
Title
Blood transfusions
Description
number of transfusion blood unites during admission
Time Frame
one month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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....
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marouf Alhalabi, MD
Organizational Affiliation
Damascus Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Damascus Hospital
City
Damascus
ZIP/Postal Code
+963
Country
Syrian Arab Republic
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Comparison of Low Against High Regimen of Proton Pump Inhibitors for Treatment of Acute Peptic Ulcer Bleeding
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