High Dose Oral Omeprazole in High Risk UGIB

GI Bleeding Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04394663
• Other study ID #: RP019
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: August 2022
• Source: King Chulalongkorn Memorial Hospital
• Contact: Rapat Pittayanon, MD
• Phone: 66804224999
• Email: rapat125[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• GI Bleeding
• Hemorrhage

Intervention

Drug:
• High-dose oral omeprazole
Local made oral omeprazole 40 mg twice daily will be prescribed for 72 hours after randomization.
• Standard IV PPI
Pantoprazole 8mg/hour IV continuous drip will be prescribed for 72 hours after randomization

Locations

Country	Name	City	State
Thailand	Rapat Pittayanon	Pathum Wan	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
King Chulalongkorn Memorial Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of 24-hour gastric pH above 6		3 days
Secondary	Rate of 3-day peptic ulcer rebleeding		3 days
Secondary	Rate of 30-day peptic ulcer rebleeding		30 days