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NCT06950489
Tegoprazan and Amoxicillin Dual Therapy
trial in H.Pylori Infection in 50 participants. Currently enrolling.
31 December 2025
Quick facts
| Lead sponsor | Soonchunhyang University Hospital |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 50 |
| Start date | 1 January 2025 |
| 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
Dual therapy for Helicobacter pylori refers to a treatment regimen that combines two agents: a potent acid suppressor (such as a proton pump inhibitor \[PPI\] or a potassium-competitive acid blocker \[PCAB\]) and the antibiotic amoxicillin. This approach is increasingly recognized as a viable alternative to traditional triple or quadruple therapies, particularly in the context of rising resistance to other antibiotics such as clarithromycin and metronidazole. Potent acid suppression increases the stability and activity of amoxicillin against H. pylori by maintaining a higher gastric pH, which is essential for optimal amoxicillin effect. High-dose dual therapy (e.g., amoxicillin 1,000 mg three times daily + standard dose of PPI three or four times daily for 14 days) has demonstrated eradication rates of 90%. In 2015, vonoprazan, a novel P-CAB, was launched in Japan and used as an alternative for PPIs for eradicating H. pylori. Dual therapy with vonoprazan and amoxicillin is particularly effective, with cure rates comparable to triple therapy and superior outcomes in clarithromycin-resistant infections. Dual therapy is generally well tolerated, with adverse event rates similar to or lower than those seen with triple or quadruple regimens. In 2018, a new P-CAB, tegoprazan, was developed in Korea and approved for H. pylori eradication. However, there was no study of tegoprazan and amoxicillin dual therapy for the treatment of H. pylori.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06950489
- Europe PMC full search
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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
- NCT06682533 — Tegoprazan- Versus PPI-based H. Pylori Eradication · 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
- NCT06682533 — Tegoprazan- Versus PPI-based H. Pylori Eradication · 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 NCT06950489 (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: 30 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06950489.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing