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NCT Number: NCT04394663

High Dose Oral Omeprazole in High Risk UGIB

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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Key information

Conditions

GI Bleeding Digestive System Diseases Gastrointestinal Diseases Gastrointestinal Hemorrhage Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Chulalongkorn Memorial Hospital, Pathum Wan, Bangkok, Thailand

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High-dose oral omeprazole

Drug

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

Standard IV PPI

Drug

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

Primary outcomes

  1. Rate of 3-day peptic ulcer rebleeding

    Time frame: 3 days

Secondary outcomes

  1. Percentage of 24-hour gastric pH above 6

    Time frame: 3 days

  2. Rate of 30-day peptic ulcer rebleeding

    Time frame: 30 days

Study contacts

Contact information is provided by the study sponsor or research team.

Rapat Pittayanon, MD

CONTACT

[email protected]

66804224999

Sponsors and collaborators

Lead sponsor

King Chulalongkorn Memorial Hospital

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
May 19, 2020
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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