NCT05901051 is a Phase 4 clinical trial of vonoprazan in Helicobacter Pylori Infection, sponsored by Shanghai Jiao Tong University School of Medicine.

Who is sponsoring NCT05901051?

NCT05901051 is sponsored by Shanghai Jiao Tong University School of Medicine.

What drugs are being tested in NCT05901051?

Interventions in NCT05901051: vonoprazan, Amoxicillin.

What condition does NCT05901051 study?

NCT05901051 studies Helicobacter Pylori Infection.

Is NCT05901051 still recruiting?

NCT05901051 is currently completed. Last updated 30 December 2024.

Last reviewed 2024-12-30 · How we verify

NCT05901051

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

High-dose Dual Therapy with Different Administration Frequencies

Completed Phase 4 Last updated 30 December 2024

What this trial tests

Phase 4 trial testing vonoprazan in Helicobacter Pylori Infection in 327 participants. Completed in 30 September 2023.

Timeline

30 March 2021

Primary endpoint
10 September 2023

30 September 2023

Quick facts

Lead sponsor	Shanghai Jiao Tong University School of Medicine
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	327
Start date	30 March 2021
Primary completion	10 September 2023
Estimated completion	30 September 2023
Sites	1 location across China

Drugs / interventions tested

vonoprazan — full drug profile →
Amoxicillin (amoxicillin) — full drug profile →

Conditions studied

Helicobacter Pylori Infection — all drugs for Helicobacter Pylori Infection →

Sponsor

Shanghai Jiao Tong University School of Medicine

Who can join

Adults 18 to 80, any sex, with Helicobacter Pylori Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is a single center, randomized controlled clinical study. The enrolled patients are HP positive. They are diagnosed as HP positive by rapid urease test and/or 13C urea breath test. According to the declaration of Helsinki, 327 patients will be included in this study. After obtaining the written informed consent of the patients, HP culture and drug sensitivity test will be conducted on all the selected patients with the success rate, adverse reactions, compliance, antibiotic resistance of HP and its impact on HP eradication.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Vonoprazan-Amoxicillin Dual Therapy With Different Amoxicillin Administration Regimens for Helicobacter pylori Treatment: A Randomized Controlled Trial.
Qiu S, Huang Y, Chen J, Guo Y, et al · · 2024 · cited 6× · PMID 39087868 · DOI 10.1111/hel.13118

Verify or expand the search:

Other recruiting trials for Helicobacter Pylori Infection

Currently open trials in the same condition.

NCT07285096 — P-CABs-based Bismuth Quadruple Therapy for Helicobacter Pylori Eradication · recruiting
NCT07358130 — Efficacies of Bismuth-amoxicillin-vonoprazan Triple Therapy and Bismuth Quadruple Therapy · NA · recruiting
NCT07165444 — Potassium-Competitive Acid Blocker Versus Proton Pump Inhibitor as A Part of Bismuth Based Quadruple Therapy for Treatme · NA · recruiting
NCT06929962 — VA Dual Sequential Therapy · Phase 4 · recruiting
NCT06959368 — Vonoprazan Evaluation Compared to Standard Triple Therapy in Helicobacter Pylori eRadication · Phase 4 · recruiting

Other Shanghai Jiao Tong University School of Medicine trials

Trials by the same sponsor.

NCT07570810 — Efficacy, Safety, and Tolerability of CS0159 Combined With Semaglutide in MAFLD Patients With Obesity and T2DM · NA · not yet recruiting
NCT07528079 — Organoid-based Sensitivity-guided Chemotherapy for Advanced / Refractory Pediatric Tumors · NA · enrolling by invitation
NCT07535710 — Aclarubicin Plus Cyclophosphamide, Vincristine, and Prednisone (CAOP) in Patients With Previously Treated Cutaneous T-ce · Phase 1, PHASE2 · not yet recruiting
NCT07535762 — Aclarubicin Plus Cyclophosphamide, Vincristine, and Prednisone (CAOP) in Patients With Previously Untreated Peripheral T · Phase 2 · not yet recruiting
NCT07350057 — A Preliminary Clinical Study on the Efficacy of Cyclophosphamide and Sirolimus Combined With VIC-1911 in Preventing Graf · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05901051 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Shanghai Jiao Tong University School of Medicine
Last refreshed: 30 December 2024

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/NCT05901051.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing