GI BleedingNCT04394663
High Dose Oral Omeprazole in High Risk UGIB
A study testing High-dose oral omeprazole and Standard IV PPI in people with GI Bleeding, run by King Chulalongkorn Memorial Hospital at 2 sites in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GI Bleeding
- What is being tested?
- High-dose oral omeprazole and Standard IV PPI
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 2 sitesThailand
- Study dates
- 1 Oct 2020to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand2 sites, 2 recruiting
- Recruiting
King Chulalongkorn Memorial Hospital
Pathum Wan, Bangkok, 10330
Rapat Pittayanon, rapat125@gmail.com
- Recruiting
Surin Hospital
Surin, 32000
Nutbordee Nalinthassanai, MD, 6644511757, nutbordee@gmail.com
About this study
Official 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
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.
- Conditions
- GI Bleeding
- Being tested
- High-dose oral omeprazole, Standard IV PPI
- Keywords
- oral proton pump inhibitor
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-dose oral omeprazoleDrug
Local made oral omeprazole 40 mg twice daily will be prescribed for 72 hours after randomization.
Standard IV PPIDrug
Pantoprazole 8mg/hour IV continuous drip will be prescribed for 72 hours after randomization
| Study group | Role | What they receive |
|---|---|---|
| High-dose oral PPI | Experimental | Omeprazole 80 mg/day (40 mg twice a day) per oral route for 72 hours Receives: Drug: High-dose oral omeprazole |
| Standard IV PPI | Active comparator | Pantoprazole 8 mg/hour IV continuous drip for 72 hours Receives: Drug: Standard IV PPI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of 3-day peptic ulcer rebleeding
Measured: 3 days
Secondary outcomes (2)
Percentage of 24-hour gastric pH above 6
Measured: 3 days
Rate of 30-day peptic ulcer rebleeding
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start1 Oct 2020
- Primary completion30 May 2025
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GI BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Chulalongkorn Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rapat Pittayanon, King Chulalongkorn Memorial Hospital
- Investigators
- Rapat Pittayanon, MD, Principal investigator, King Chulalongkorn Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04394663
- Sponsor's protocol ID
- RP019
- Status last verified
- Sep 2025
- First submitted
- 14 May 2020
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sriyudthsak K, Nalinthassanai N, Sriapiraksa B, Rattanachaisit P, Patcharatrakul T, Pittayanon R. High-Dose Oral Omeprazole Versus Continuous Intravenous Pantoprazole in Patients With High-Risk Peptic Ulcer Bleeding: A Single-Blinded Multicenter RCT. J Gastroenterol Hepatol. 2026 Jul 12. doi: 10.1111/jgh.70566. Online ahead of print.
PubMed 42438169
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04394663
- Acronym / sponsor ID
- RP019
- Conditions
- GI Bleeding
- Keywords
- oral proton pump inhibitor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- King Chulalongkorn Memorial HospitalUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 19 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| High-dose oral PPI | Experimental | Drug: High-dose oral omeprazoleOmeprazole 80 mg/day (40 mg twice a day) per oral route for 72 hours |
| Standard IV PPI | Active comparator | Drug: Standard IV PPIPantoprazole 8 mg/hour IV continuous drip for 72 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-dose oral omeprazoleLocal made oral omeprazole 40 mg twice daily will be prescribed for 72 hours after randomization. | Drug | High-dose oral PPI |
| Standard IV PPIPantoprazole 8mg/hour IV continuous drip will be prescribed for 72 hours after randomization | Drug | Standard IV PPI |
Primary outcome
Rate of 3-day peptic ulcer rebleeding
Time frame: 3 days
2 secondary outcomes
Percentage of 24-hour gastric pH above 6
Time frame: 3 days
Rate of 30-day peptic ulcer rebleeding
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Derived from this study: PubMed 42438169Sriyudthsak K, Nalinthassanai N, Sriapiraksa B, Rattanachaisit P, Patcharatrakul T, Pittayanon R. High-Dose Oral Omeprazole Versus Continuous Intravenous Pantoprazole in Patients With High-Risk Peptic Ulcer Bleeding: A Single-Blinded Multicenter RCT. J Gastroenterol Hepatol. 2026 Jul 12. doi: 10.1111/jgh.70566. Online ahead of print.
Related trials for GI Bleeding
RecruitingObservational study
Treatment Outcomes and Predictors After Endovascular Intervention for Portal Hypertension-Related Gastrointestinal Bleeding in Cirrhosis
Cirrhosis, Portal Hypertension Related to Cirrhosis
Active, not recruitingObservational study
Resumption of Anticoagulation After Major Gastrointestinal Bleeding in Patients With Atrial Fibrillation
Atrial Fibrillation (AF), Major Gastrointestinal Bleeding (MGIB)
RecruitingPhase 2
Fecal Microbiota Transplantation for Radiation-Induced Proctopathy
Radiation Induced Proctitis
Recruiting
OTSC vs. Angiographic Embolization in Patients With Refractory Non-variceal Upper Gastrointestinal Bleeding
Upper Gastrointestinal Bleeding
Recruiting
Fexuprazan for Prevention of Upper Gastrointestinal Bleeding in High Bleeding Risk Patients Receiving Dual Antiplatelet Therapy
Acute Coronary Syndromes (ACS), Coronary Artery Disease (CAD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rapat Pittayanon, MD principal investigator
King Chulalongkorn Memorial Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-dose oral omeprazole and Standard IV PPI in people with GI Bleeding, run by King Chulalongkorn Memorial Hospital at 2 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rapat Pittayanon, MD (66804224999, rapat125@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of 3-day peptic ulcer rebleeding (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04394663, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.