Tegoprazan- Versus PPI-based H. Pylori Eradication

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20-80
SponsorSoonchunhyang University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Gastroscopy can be performed

H. pylori test and pathological analysis can be performed

Disqualifiers

Age < 20 or > 80 years

Anemia (serum hemoglobin level < 10 g/dL)

Severe systemic disease

Advanced chronic liver disease

Trial population

H. pylori-infected patients

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 4 trial groups
Group A: PPI-BID group
Group B: Tegoprazan-BID group
Group C: PPI-QID group
Group D: Tegoprazan-QID group

Trial outcomes

Primary outcomes

1

H. pylori eradication rates

Urea breath test after completing H. pylori eradication regimen

Time frame
6 weeks

Secondary outcomes

1

Treatment compliance

Assessment of patients' numbers completing H. pylori eradication regimen

Time frame
6 weeks
2

Drug-related adverse event rate

Bitter tongue, nausea/vomiting, bloating, diarrhea, and abdominal pain during H. pylori treatment

Time frame
6 weeks

Other outcomes

Sponsors and contacts

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