Actively Recruiting
High Dose Oral Omeprazole Versus Standard Continuous Intravenous Pantoprazole in Patients With Peptic Ulcer Bleeding After Endoscopy; Non-inferiority Randomized Controlled Trial
Led by King Chulalongkorn Memorial Hospital · Updated on 2025-09-18
128
Participants Needed
2
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Peptic ulcer bleeding is a leading cause of upper gastrointestinal bleeding worldwide. Researchers are evaluating a high-dose, locally made oral proton pump inhibitor (omeprazole) compared to the standard intravenous proton pump inhibitor (pantoprazole) to prevent rebleeding after successful endoscopic treatment. This trial aims to confirm if the oral treatment is not worse than the standard IV treatment in reducing rebleeding and to monitor gastric acid levels over 24 hours. Participants will receive either oral omeprazole at 40 mg twice daily or continuous intravenous pantoprazole at 8 mg per hour, both for 72 hours after endoscopic hemostasis. These two treatment groups are compared in a randomized design to assess their effects on preventing peptic ulcer rebleeding. During the study, patients will be monitored for rebleeding events within 3 and 30 days. Gastric pH will be measured over 24 hours to evaluate acid suppression. The main outcome is the rate of rebleeding within 3 days. The trial includes safety monitoring and follow-up for up to 30 days. Participants’ clinical status and treatment responses will be carefully recorded throughout the study period.
CONDITIONS
Brief Title
High Dose Oral Omeprazole in High Risk UGIB
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with peptic ulcer bleeding showing Forrest classification Ia, Ib, or IIa ulcers on endoscopy
- Age 18 years or older
You will not qualify if you...
- Decline to participate
- Pregnancy or lactation
- Low-risk peptic ulcer bleeding such as clean base ulcer or flat pigmented spot
- Non-peptic ulcer bleeding causes like erosive gastritis, Mallory Weiss tear, varices, vascular lesions, or malignant ulcer
- Bleeding disorders
- Terminal cancer
- End-stage renal disease on hemodialysis
- Decompensated liver cirrhosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 72 hours
Participants receive either high-dose oral omeprazole or standard continuous intravenous pantoprazole for peptic ulcer bleeding.
1 baseline visit and daily monitoring during treatment
Duration - up to 30 days
Participants are monitored for peptic ulcer rebleeding and gastric pH levels after treatment.
Follow-up visits during the 30-day period
Trial Site Locations
Total: 2 locations
1
King Chulalongkorn Memorial Hospital
Pathum Wan, Bangkok, Thailand, 10330
Actively Recruiting
2
Surin Hospital
Surin, Thailand, 32000
Actively Recruiting
Research Team
R
Rapat Pittayanon, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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