RecruitingNot ApplicableNCT04394663

High Dose Oral Omeprazole in High Risk UGIB

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


Sponsor

King Chulalongkorn Memorial Hospital

Enrollment

128 participants

Start Date

Oct 1, 2020

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria2

  • 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 Criteria8

  • 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

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Interventions

DRUGHigh-dose oral omeprazole

Local made oral omeprazole 40 mg twice daily will be prescribed for 72 hours after randomization.

DRUGStandard IV PPI

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


Locations(2)

King Chulalongkorn Memorial Hospital

Pathum Wan, Bangkok, Thailand

Surin Hospital

Surin, Thailand

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NCT04394663


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