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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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 in term of rebleeding, as well as 24-hour gastric pH monitoring.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Thailand
King Chulalongkorn Memorial Hospital
RECRUITING
Pathum Wan
Surin Hospital
RECRUITING
Surin
Contact Information
Primary
Rapat Pittayanon, MD
rapat125@gmail.com
66804224999
Time Frame
Start Date: 2020-10-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 128
Treatments
Experimental: High-dose oral PPI
Omeprazole 80 mg/day (40 mg twice a day) per oral route for 72 hours
Active_comparator: Standard IV PPI
Pantoprazole 8 mg/hour IV continuous drip for 72 hours
Related Therapeutic Areas
Sponsors
Leads: King Chulalongkorn Memorial Hospital

This content was sourced from clinicaltrials.gov