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High Dose Oral Omeprazole in High Risk UGIB

Primary Purpose

GI Bleeding

Status
Recruiting
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
High-dose oral omeprazole
Standard IV PPI
Sponsored by
King Chulalongkorn Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for GI Bleeding focused on measuring oral proton pump inhibitor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with peptic ulcer bleeding and endoscopic finding show ulcer with Forrest classification Ia (spurting haemorrhage), IIa (oozing haemorrhage), Ib (non-bleeding visible vessel)
  • Age > 18 years old

Exclusion Criteria:

  • Deny to participate
  • Pregnancy or lactation
  • Low risk peptic ulcer bleeding including clean base ulcer, flat pigmented spot
  • Non-peptic ulcer bleeding eg. erosive gastritis/duodenitis, Mallory Weiss tear, esophageal/gastric/duodenal varices, vascular lesions (eg. Dieulafoy) , malignant ulcer
  • Bleeding tendency
  • Terminal stage of cancer
  • ESRD on hemodialysis
  • Decompensated liver cirrhosis

Sites / Locations

  • Rapat PittayanonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High-dose oral PPI

Standard IV PPI

Arm Description

Omeprazole 80 mg/day (40 mg twice a day) per oral route for 72 hours

Pantoprazole 8 mg/hour IV continuous drip for 72 hours

Outcomes

Primary Outcome Measures

Percentage of 24-hour gastric pH above 6

Secondary Outcome Measures

Rate of 3-day peptic ulcer rebleeding
Rate of 30-day peptic ulcer rebleeding

Full Information

First Posted
May 14, 2020
Last Updated
August 23, 2022
Sponsor
King Chulalongkorn Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04394663
Brief Title
High Dose Oral Omeprazole in High Risk UGIB
Official Title
High Dose Oral Omeprazole Versus Standard Continuous Intravenous Pantoprazole in Patient With Peptic Ulcer Bleeding and Undergo Successful Therapeutic Endoscopy; Non-inferiority Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Chulalongkorn Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Peptic ulcer bleeding is the most common etiology in upper gastrointestinal bleeding all over the world. After endoscopic treatment, proton pump inhibitor (PPI) is recommended to prevent re-bleeding. Intravenous PPI is recommended as a standard treatment.In the past, there were many trials showing the efficacy of high-dose oral PPI after endoscopic hemostasis but most were industrial sponsor which assessing an expensive PPI. Moreover, the number of patients in those studies were insufficient to confirm a non-inferiority outcome in term of rebleeding by using oral PPI. This study will evaluate a high-dose, local-made PPI (omeprazole) in peptic ulcer treatment after successful endoscopic hemostasis compared to standard IV PPI continuous drip.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
GI Bleeding
Keywords
oral proton pump inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The patients with successful endoscopic hemostasis in peptic ulcer bleeding were equally randomized to either high-dose oral PPI or standard IV PPI for 3 days
Masking
Outcomes Assessor
Masking Description
The outcomes assessor will not know the assigned treatment.
Allocation
Randomized
Enrollment
76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High-dose oral PPI
Arm Type
Experimental
Arm Description
Omeprazole 80 mg/day (40 mg twice a day) per oral route for 72 hours
Arm Title
Standard IV PPI
Arm Type
Active Comparator
Arm Description
Pantoprazole 8 mg/hour IV continuous drip for 72 hours
Intervention Type
Drug
Intervention Name(s)
High-dose oral omeprazole
Intervention Description
Local made oral omeprazole 40 mg twice daily will be prescribed for 72 hours after randomization.
Intervention Type
Drug
Intervention Name(s)
Standard IV PPI
Intervention Description
Pantoprazole 8mg/hour IV continuous drip will be prescribed for 72 hours after randomization
Primary Outcome Measure Information:
Title
Percentage of 24-hour gastric pH above 6
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Rate of 3-day peptic ulcer rebleeding
Time Frame
3 days
Title
Rate of 30-day peptic ulcer rebleeding
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with peptic ulcer bleeding and endoscopic finding show ulcer with Forrest classification Ia (spurting haemorrhage), IIa (oozing haemorrhage), Ib (non-bleeding visible vessel) Age > 18 years old Exclusion Criteria: Deny to participate Pregnancy or lactation Low risk peptic ulcer bleeding including clean base ulcer, flat pigmented spot Non-peptic ulcer bleeding eg. erosive gastritis/duodenitis, Mallory Weiss tear, esophageal/gastric/duodenal varices, vascular lesions (eg. Dieulafoy) , malignant ulcer Bleeding tendency Terminal stage of cancer ESRD on hemodialysis Decompensated liver cirrhosis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rapat Pittayanon, MD
Phone
66804224999
Email
rapat125@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rapat Pittayanon, MD
Organizational Affiliation
King Chulalongkorn Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rapat Pittayanon
City
Pathum Wan
State/Province
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rapat Pittayanon
Email
rapat125@gmail.com

12. IPD Sharing Statement

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High Dose Oral Omeprazole in High Risk UGIB

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