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NCT06682533
Tegoprazan- Versus PPI-based H. Pylori Eradication
trial in H.Pylori Infection in 200 participants. Currently enrolling.
31 December 2025
Quick facts
| Lead sponsor | Soonchunhyang University Hospital |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 200 |
| Start date | 1 December 2024 |
| Primary completion | 31 December 2025 |
| Estimated completion | 31 December 2025 |
| Sites | 1 location across South Korea |
Conditions studied
- H.Pylori Infection — all drugs for H.Pylori Infection →
Sponsor
Soonchunhyang University Hospital
Who can join
Adults 20 to 80, any sex, with H.Pylori Infection. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Related trials
Other recruiting trials for H.Pylori Infection
Currently open trials in the same condition.
- NCT07344506 — CURE-H. Pylori: A Trial on the Combination of Anti-Ulcerants and Levofloxacin-Based Therapy for Helicobacter Pylori Erad · Phase 4 · recruiting
- NCT06950489 — Tegoprazan and Amoxicillin Dual Therapy · recruiting
- NCT06684860 — RUT vs. Molecular Testing for H. Pylori · recruiting
Other Soonchunhyang University Hospital trials
Trials by the same sponsor.
- NCT07213596 — Virtual Reality Treatment for Trauma Related to COVID-19 Infection · NA · not yet recruiting
- NCT06950489 — Tegoprazan and Amoxicillin Dual Therapy · recruiting
- NCT06684860 — RUT vs. Molecular Testing for H. Pylori · recruiting
- NCT06369896 — Digital Single-operator Cholangioscopy and Intraductal Ultrasound for Nonicteric Biliary Strictures · not yet recruiting
- NCT06431737 — Comparison of Twice- and Four-times-daily Amoxicillin Administration in 2-week Tegoprazan-based H. Pylori Eradication · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06682533 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Soonchunhyang University Hospital
- Last refreshed: 29 April 2025
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