Clinical trial NCT06682533: Tegoprazan- Versus PPI-based H. Pylori Eradication
Official title: Efficacy and Tolerability of 14-Day Tegoprazan-based Triple Therapy for Eradication of Helicobacter Pylori Eradication: A Retrospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: H.Pylori Infection
Lead sponsor: Soonchunhyang University Hospital
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: H. pylori-infected patients

Brief summary: In 2015, vonoprazan, a potassium-competitive blocker (P-CAB), was launched in Japan and used as an alternative for proton pump inhibitors (PPIs) for eradicating Helicobacter pylori. In recent studies, vonoprazan-based triple therapy significantly increased the eradication rate from 72.8% to 87.9%, compared to PPI treatment group. Accordingly, the Japanese Helicobacter treatment guidelines recommend prescribing P-CAB for eradication treatment. In 2018, a new P-CAB, tegoprazan, was developed in Korea and approved for gastric ulcer treatment. Subsequently, it was proven effective in the treatment of reflux esophagitis compared to PPIs in a non-inferiority clinical trial. P-CAB can increase the gastric pH to 6 or higher within 7 hours after taking tegoprazan. Because tegoprazan can be taken after meals, it can improve patient compliance for H. pylori eradication. Unlike vonoprazan in Japan, however, tegoprazan-based eradication in Korean population was similar to conventional PPI-based treatment. To date, the eradication success rates of PPI and tegoprazan-based triple therapy were 76.4-84.2% and 77.3-84.3%, respectively, and there was no significant difference between the two treatment groups.

Bismuth has long been used as a semi-metal in the dyspepsia and traveler's diarrhea. In H. pylori eradication therapy, several guidelines recommended the addition of bismuth to treatment regimens. Recently, bismuth was added to the 2-week triple regimen to increase the first-line H. pylori eradication rate in countries with high antibiotic resistance. The H. pylori eradication significantly increased from 87.5-88.1% to 95.8-97.3% in a recent study. The odds ratio was 1.63-2.18 in bismuth-added treatment group, compared to no use of bismuth group. In subgroup analysis, odd ratio was 1.66-2.22 in high clarithromycin-resistant areas. However, there was no comparative analysis of PPIs and tegoprazan in a bismuth-added triple therapy.

Detailed description: The investigators aim to evaluate the eradication success rate and treatment compliance between PPI and tegoprazan in first-line H. pylori treatment with adding bismuth.

Eligibility criteria: Inclusion Criteria:

* Gastroscopy can be performed
* H. pylori test and pathological analysis can be performed

Exclusion Criteria:

* Age \< 20 or \> 80 years
* Anemia (serum hemoglobin level \< 10 g/dL)
* Severe systemic disease
* Advanced chronic liver disease
* Use of certain medications, including proton pump inhibitors, H2- receptor antagonists, or antibiotics
* History of H. pylori eradication
* Drug allergy to antibiotics
* History of gastric surgery
* Recent history of upper gastrointestinal bleeding

Primary outcomes:
measure: H. pylori eradication rates
timeFrame: 6 weeks
Secondary outcomes:
measure: Treatment compliance
timeFrame: 6 weeks
measure: Drug-related adverse event rate
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Digestive Disease Center, Soonchunhyang University Hospital
Study officials:
affiliation: Soonchunhyang University Hospital
name: Jun-Hyung Cho, M.D.
role: PRINCIPAL_INVESTIGATOR
References: