Health TrialsbyHealthPanel

High Dose Oral Omeprazole in High Risk UGIB

ConditionGI Bleeding
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKing Chulalongkorn Memorial Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

128 Participants
are divided into 2 treatment groups
Group A: High-dose oral PPIExperimental treatment 1 intervention
Group B: Standard IV PPIActive comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

King Chulalongkorn Memorial Hospital

Lead sponsor

Source ClinicalTrials.gov
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