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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-dose oral PPI | Experimental | Omeprazole 80 mg/day (40 mg twice a day) per oral route for 72 hours |
|
| Standard IV PPI | Active Comparator | Pantoprazole 8 mg/hour IV continuous drip for 72 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-dose oral omeprazole | Drug | Local made oral omeprazole 40 mg twice daily will be prescribed for 72 hours after randomization. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of 3-day peptic ulcer rebleeding | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of 24-hour gastric pH above 6 | 3 days | |
| Rate of 30-day peptic ulcer rebleeding | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rapat Pittayanon, MD | Contact | 66804224999 | rapat125@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Rapat Pittayanon, MD | King Chulalongkorn Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Chulalongkorn Memorial Hospital | Recruiting | Pathum Wan | Bangkok | 10330 | Thailand |
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| ID | Term |
|---|---|
| D006471 | Gastrointestinal Hemorrhage |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D009853 | Omeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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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 days
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The outcomes assessor will not know the assigned treatment.
| Standard IV PPI | Drug | Pantoprazole 8mg/hour IV continuous drip will be prescribed for 72 hours after randomization |
|
| Surin Hospital | Recruiting | Surin | 32000 | Thailand |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |