High Dose Oral Omeprazole in High Risk UGIB

Sponsor

King Chulalongkorn Memorial Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04394663

Collaborator

(none)

322

Enrollment

Location

Arms

Anticipated Duration (Months)

5.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
GI Bleeding	Drug: High-dose oral omeprazole Drug: Standard IV PPI	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

322 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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 daysThe 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:

Single (Outcomes Assessor)

Masking Description:

The outcomes assessor will not know the assigned treatment.

Primary Purpose:

Treatment

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

Actual Study Start Date :

Oct 1, 2020

Anticipated Primary Completion Date :

Jun 30, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: High-dose oral PPI Omeprazole 80 mg/day (40 mg twice a day) per oral route for 72 hours	Drug: High-dose oral omeprazole 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	Drug: Standard IV PPI Pantoprazole 8mg/hour IV continuous drip will be prescribed for 72 hours after randomization

Arm

Intervention/Treatment

Experimental: High-dose oral PPI

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

Drug: High-dose oral omeprazole

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

Drug: Standard IV PPI

Pantoprazole 8mg/hour IV continuous drip will be prescribed for 72 hours after randomization

Outcome Measures

Primary Outcome Measures

Rate of 30-day peptic ulcer rebleeding [30 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rapat Pittayanon	Pathum Wan	Bangkok	Thailand	10330

Sponsors and Collaborators

King Chulalongkorn Memorial Hospital

Investigators

Principal Investigator: Rapat Pittayanon, MD, King Chulalongkorn Memorial Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rapat Pittayanon, Principle investigator, Gastrointestinal Unit, King Chulalongkorn Memorial Hospital

ClinicalTrials.gov Identifier:

NCT04394663

Other Study ID Numbers:

RP019

First Posted:

May 19, 2020

Last Update Posted:

Apr 1, 2022

Last Verified:

Mar 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Rapat Pittayanon, Principle investigator, Gastrointestinal Unit, King Chulalongkorn Memorial Hospital

oral proton pump inhibitor

Additional relevant MeSH terms:

Hemorrhage

Omeprazole

Study Results

No Results Posted as of Apr 1, 2022