- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04394663
High Dose Oral Omeprazole in High Risk UGIB
August 23, 2022 updated by: Rapat Pittayanon, King Chulalongkorn Memorial Hospital
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
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
76
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Rapat Pittayanon, MD
- Phone Number: 66804224999
- Email: rapat125@gmail.com
Study Locations
-
-
Bangkok
-
Pathum Wan, Bangkok, Thailand, 10330
- Recruiting
- Rapat Pittayanon
-
Contact:
- Rapat Pittayanon
- Email: rapat125@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: High-dose oral PPI
Omeprazole 80 mg/day (40 mg twice a day) per oral route for 72 hours
|
Local made oral omeprazole 40 mg twice daily will be prescribed for 72 hours after randomization.
|
Active Comparator: Standard IV PPI
Pantoprazole 8 mg/hour IV continuous drip for 72 hours
|
Pantoprazole 8mg/hour IV continuous drip will be prescribed for 72 hours after randomization
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of 24-hour gastric pH above 6
Time Frame: 3 days
|
3 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of 3-day peptic ulcer rebleeding
Time Frame: 3 days
|
3 days
|
Rate of 30-day peptic ulcer rebleeding
Time Frame: 30 days
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Rapat Pittayanon, MD, King Chulalongkorn Memorial Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2020
Primary Completion (Anticipated)
June 30, 2025
Study Completion (Anticipated)
December 31, 2025
Study Registration Dates
First Submitted
May 14, 2020
First Submitted That Met QC Criteria
May 14, 2020
First Posted (Actual)
May 19, 2020
Study Record Updates
Last Update Posted (Actual)
August 26, 2022
Last Update Submitted That Met QC Criteria
August 23, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RP019
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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