Peptic Ulcer BleedingTALENTNCT06894992
Tegoprazan And Lansoprazole Effectiveness in Bleeding Peptic Ulcer Treatment
A study testing Tegoprazan and Lansoprazole in people with Peptic Ulcer Bleeding, run by Mario Steffanus at 2 sites in Indonesia.
Trial summary
The goal of this clinical trial is to compare the effects of tegoprazan vs lansoprazole in healing bleeding peptic ulcers. It will also teach about the safety of both modalities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peptic Ulcer Bleeding
- What is being tested?
- Tegoprazan and Lansoprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 2 sitesIndonesia
- Study dates
- 1 May 2025to 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
- Subjects diagnosed with upper gastrointestinal bleeding caused by peptic ulcer through gastroscopic examination
Who cannot join
- Allergic to Tegoprazan or Lansoprazole
- Diagnosed with gastric or duodenal cancer, pregnant
- History of H. pylori infection treatment failure
- Presence of comorbidities such as chronic kidney disease or decompensated liver cirrhosis
- Alcohol consumption
- Undergoing chemotherapy
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia2 sites, 2 recruiting
- Recruiting
Cipto Mangunkusumo National General Hospital
Jakarta, DKI Jakarta, 10430
Achmad Fauzi, MD, +6281386668655, ppfauzidrgm@gmail.com
- Recruiting
Atma Jaya Hospital
Jakarta, DKI Jakarta, 14440
Mario Steffanus MD, +6281288002263, mario.steffanus@atmajaya.ac.id
About this study
Official title: A Comparison of The Effectiveness of Tegoprazan and Lansoprazole in Achieving Cure Rates in Patients With Bleeding Peptic Ulcers: A Double-Blind Randomized Trial
The goal of this clinical trial is to compare the effects of tegoprazan vs lansoprazole in healing bleeding peptic ulcers. It will also teach about the safety of both modalities. The main questions it aims to answer are:
How does the effectiveness of Tegoprazan compare with Lansoprazole in two weeks of healing rate bleeding peptic ulcer patients in the Indonesian population?
Read more
Researchers will compare the drug tegoprazan to lansoprazole with a double-blind randomized control to see their effect on healing bleeding peptic ulcers.
Participants will:
Take drug tegoprazan 50 mg OD or lansoprazole 30 mg OD every day for 2 weeks Endoscopic examination at the beginning before treatment and after completion of treatment within 2 weeks Record of their adverse effect occurrence
Read the detailed description
Peptic ulcer disease (PUD) is a condition characterized by disruption of the gastric and duodenal mucosal lining due to exposure to gastric acid or pepsin. Major causes include Helicobacter pylori infection, nonsteroidal anti-inflammatory drug (NSAID) use, gastric bypass surgery, lifestyle factors such as smoking and alcohol consumption, and genetic predisposition. PUD affects 5-10% of the global population and poses a significant healthcare burden, with prevalence rising from 6.43 million to 8.09 million cases between 1990 and 2019.
Current PUD treatment involves acid-suppressing agents and H. pylori eradication when indicated. Proton pump inhibitors (PPIs) play a key role by irreversibly inhibiting H⁺/K⁺ ATPase in gastric parietal cells, effectively maintaining gastric pH ≥4, which is essential for ulcer healing and preventing complications like bleeding. Lansoprazole, a widely used PPI, has demonstrated strong efficacy, with healing rates of 64%, 75.6%, and 95.7% at 2, 4, and 8 weeks, respectively. However, PPIs have limitations, including short plasma half-life, food dependency, breakthrough symptoms, and potential long-term adverse effects such as hypergastrinemia, acid rebound, and gut microbiota alterations.
To overcome these limitations, potassium-competitive acid blockers (PCABs) like vonoprazan and tegoprazan have been developed. PCABs provide faster, more stable, and potent acid suppression compared to PPIs. Unlike PPIs, which require activation in an acidic environment, PCABs directly inhibit H⁺/K⁺ ATPase by competitively binding to potassium sites, offering more predictable pharmacokinetics. Tegoprazan, a newer PCAB, has demonstrated superior acid suppression and a faster onset of action than vonoprazan, making it highly relevant for ulcer healing and preventing nocturnal acid breakthrough.
Studies suggest that PCABs are non-inferior to PPIs in treating PUD, with some data indicating that tegoprazan offers stronger, faster, and more stable acid suppression than vonoprazan. However, no studies have compared the healing rates of tegoprazan and lansoprazole specifically in bleeding PUD patients over a 2-week treatment period. Given the importance of optimizing treatment for bleeding PUD in Indonesia, this study aims to compare the effectiveness of tegoprazan and lansoprazole in ulcer healing over a short-term evaluation period.
This research is expected to contribute to the scientific literature by providing clinical trial data specific to the Indonesian population, inform clinical decision-making by identifying the most effective treatment for bleeding PUD, and ultimately improve patient outcomes by ensuring faster healing and better symptom management.
- Conditions
- Peptic Ulcer Bleeding
- Being tested
- Tegoprazan, Lansoprazole
- Keywords
- Tegoprazan, Lansoprazole, Peptic Ulcer, Peptic Ulcer Bleeding, Healing Rate
- Medical subject headings
- Peptic Ulcer Hemorrhage, Peptic Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TegoprazanDrug
Also called Potassium Channel Acid Blocker, PCAB
Tegoprazan 50 mg tab PO OD in 2 weeks
LansoprazoleDrug
Also called Proton Pump Inhibitor, PPI
Lansoprazole 30 mg tab PO OD in 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Potassium Channel Acid Blocker | Experimental | Each randomized patients will consume Tegoprazan 50 mg tab PO OD for 2 weeks Receives: Drug: Tegoprazan |
| Proton Pump Inhibitor | Active comparator | Each randomized patients will consume Lansoprazole 30 mg tab PO OD for 2 weeks Receives: Drug: Lansoprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing Rate
The healing rate will be rated using Forrest Classification
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start1 May 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peptic Ulcer 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
- Masking
- None (open label)
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mario Steffanus
- Sponsor type
- University, hospital or other
- Collaborators
- Dr Cipto Mangunkusumo General Hospital
- Responsible party
- Sponsor-investigator, Mario Steffanus, Dr Cipto Mangunkusumo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06894992
- Sponsor's protocol ID
- 24-12-1819
- Acronym
- TALENT
- Status last verified
- May 2025
- First submitted
- 19 Mar 2025
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of The Effectiveness of Tegoprazan and Lansoprazole in Achieving Cure Rates in Patients With Bleeding Peptic Ulcers: A Double-Blind Randomized Trial
- ClinicalTrials.gov ID
- NCT06894992
- Acronym / sponsor ID
- TALENT / 24-12-1819
- Conditions
- Peptic Ulcer Bleeding
- Keywords
- Tegoprazan, Lansoprazole, Peptic Ulcer, Peptic Ulcer Bleeding, Healing Rate
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Mario SteffanusUniversity, hospital or other
- Collaborators
- Dr Cipto Mangunkusumo General Hospital
- Study start
- 1 May 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 26 Mar 2025 (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.
The goal of this clinical trial is to compare the effects of tegoprazan vs lansoprazole in healing bleeding peptic ulcers. It will also teach about the safety of both modalities. The main questions it aims to answer are:
How does the effectiveness of Tegoprazan compare with Lansoprazole in two weeks of healing rate bleeding peptic ulcer patients in the Indonesian population?
Researchers will compare the drug tegoprazan to lansoprazole with a double-blind randomized control to see their effect on healing bleeding peptic ulcers.
Participants will:
Take drug tegoprazan 50 mg OD or lansoprazole 30 mg OD every day for 2 weeks Endoscopic examination at the beginning before treatment and after completion of treatment within 2 weeks Record of their adverse effect occurrence
Detailed description
Peptic ulcer disease (PUD) is a condition characterized by disruption of the gastric and duodenal mucosal lining due to exposure to gastric acid or pepsin. Major causes include Helicobacter pylori infection, nonsteroidal anti-inflammatory drug (NSAID) use, gastric bypass surgery, lifestyle factors such as smoking and alcohol consumption, and genetic predisposition. PUD affects 5-10% of the global population and poses a significant healthcare burden, with prevalence rising from 6.43 million to 8.09 million cases between 1990 and 2019.
Current PUD treatment involves acid-suppressing agents and H. pylori eradication when indicated. Proton pump inhibitors (PPIs) play a key role by irreversibly inhibiting H⁺/K⁺ ATPase in gastric parietal cells, effectively maintaining gastric pH ≥4, which is essential for ulcer healing and preventing complications like bleeding. Lansoprazole, a widely used PPI, has demonstrated strong efficacy, with healing rates of 64%, 75.6%, and 95.7% at 2, 4, and 8 weeks, respectively. However, PPIs have limitations, including short plasma half-life, food dependency, breakthrough symptoms, and potential long-term adverse effects such as hypergastrinemia, acid rebound, and gut microbiota alterations.
To overcome these limitations, potassium-competitive acid blockers (PCABs) like vonoprazan and tegoprazan have been developed. PCABs provide faster, more stable, and potent acid suppression compared to PPIs. Unlike PPIs, which require activation in an acidic environment, PCABs directly inhibit H⁺/K⁺ ATPase by competitively binding to potassium sites, offering more predictable pharmacokinetics. Tegoprazan, a newer PCAB, has demonstrated superior acid suppression and a faster onset of action than vonoprazan, making it highly relevant for ulcer healing and preventing nocturnal acid breakthrough.
Studies suggest that PCABs are non-inferior to PPIs in treating PUD, with some data indicating that tegoprazan offers stronger, faster, and more stable acid suppression than vonoprazan. However, no studies have compared the healing rates of tegoprazan and lansoprazole specifically in bleeding PUD patients over a 2-week treatment period. Given the importance of optimizing treatment for bleeding PUD in Indonesia, this study aims to compare the effectiveness of tegoprazan and lansoprazole in ulcer healing over a short-term evaluation period.
This research is expected to contribute to the scientific literature by providing clinical trial data specific to the Indonesian population, inform clinical decision-making by identifying the most effective treatment for bleeding PUD, and ultimately improve patient outcomes by ensuring faster healing and better symptom management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Potassium Channel Acid Blocker | Experimental | Drug: TegoprazanEach randomized patients will consume Tegoprazan 50 mg tab PO OD for 2 weeks |
| Proton Pump Inhibitor | Active comparator | Drug: LansoprazoleEach randomized patients will consume Lansoprazole 30 mg tab PO OD for 2 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects diagnosed with upper gastrointestinal bleeding caused by peptic ulcer through gastroscopic examination
Key exclusion criteria (6 listed)
- Allergic to Tegoprazan or Lansoprazole
- Diagnosed with gastric or duodenal cancer, pregnant
- History of H. pylori infection treatment failure
- Presence of comorbidities such as chronic kidney disease or decompensated liver cirrhosis
- Alcohol consumption
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 |
|---|---|---|
| TegoprazanAlso: Potassium Channel Acid Blocker, PCABTegoprazan 50 mg tab PO OD in 2 weeks | Drug | Potassium Channel Acid Blocker |
| LansoprazoleAlso: Proton Pump Inhibitor, PPILansoprazole 30 mg tab PO OD in 2 weeks | Drug | Proton Pump Inhibitor |
Primary outcome
Healing Rate
Time frame: 2 weeks
The healing rate will be rated using Forrest Classification
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 29 May 2025.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tegoprazan and Lansoprazole in people with Peptic Ulcer Bleeding, run by Mario Steffanus at 2 sites in Indonesia.
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 1 inclusion and 6 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 29 May 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 Indonesia. 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 Mario Steffanus MD (+6281288002263, mario.steffanus@atmajaya.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing Rate (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 May 2025.