Clinical trial NCT06894992: Tegoprazan And Lansoprazole Effectiveness in Bleeding Peptic Ulcer Treatment
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peptic Ulcer Bleeding
Keywords: Tegoprazan
Lansoprazole
Peptic Ulcer
Peptic Ulcer Bleeding
Healing Rate
Lead sponsor: Dr Cipto Mangunkusumo General Hospital
Sponsor class: OTHER
Collaborators: name: Dr Cipto Mangunkusumo General Hospital
First posted: 2025-03-26
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Subjects diagnosed with upper gastrointestinal bleeding caused by peptic ulcer through gastroscopic examination

Exclusion Criteria:

* 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

Primary outcomes:
measure: Healing Rate
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Cipto Mangunkusumo National General Hospital
state: DKI Jakarta
city: Jakarta
country: Indonesia
facility: Atma Jaya Hospital
state: DKI Jakarta
Study officials:
References: