NCT05469685 is a Phase 4 clinical trial of Vonoprazan in Helicobacter Pylori Infection, sponsored by Nanjing First Hospital, Nanjing Medical University.

Who is sponsoring NCT05469685?

NCT05469685 is sponsored by Nanjing First Hospital, Nanjing Medical University.

What drugs are being tested in NCT05469685?

Interventions in NCT05469685: Vonoprazan, Amoxicillin.

What condition does NCT05469685 study?

NCT05469685 studies Helicobacter Pylori Infection.

Is NCT05469685 still recruiting?

NCT05469685 is currently completed. Last updated 13 June 2024.

Last reviewed 2024-06-13 · How we verify

NCT05469685

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

Efficacy and Safety of Dual Therapy for Helicobacter Pylori Eradication

Completed Phase 4 Last updated 13 June 2024

What this trial tests

Phase 4 trial testing Vonoprazan in Helicobacter Pylori Infection in 914 participants. Completed in 30 September 2023.

Timeline

1 August 2022

Primary endpoint
31 August 2023

30 September 2023

Quick facts

Lead sponsor	Nanjing First Hospital, Nanjing Medical University
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	914
Start date	1 August 2022
Primary completion	31 August 2023
Estimated completion	30 September 2023
Sites	10 locations 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

Nanjing First Hospital, Nanjing Medical University

Who can join

Adults 18 to 65, any sex, with Helicobacter Pylori Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study was to evaluate the Efficacy and Safety of Vonoprazan- amoxicillin dual therapy for Helicobacter Pylori eradication

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

A randomized clinical study on the efficacy of vonoprazan combined with amoxicillin duo regimen for the eradication of Helicobacter pylori.
Yang F, Yu B, Qin L, Dai X. · · 2023 · cited 14× · PMID 37832048 · DOI 10.1097/md.0000000000035610
Overcoming antibiotic-resistant Helicobacter pylori infection: Current challenges and emerging approaches.
Rocha GR, Lemos FFB, Silva LGO, Luz MS, et al · · 2025 · cited 7× · PMID 40093672 · DOI 10.3748/wjg.v31.i10.102289
The efficacy and safety of Vonoprazan and Tegoprazan in Helicobacter pylori eradication: a comprehensive systematic review and meta-analysis of randomized controlled trials.
Jin T, Wu W, Zhang L, Xuan H, et al · · 2025 · cited 5× · PMID 39898357 · DOI 10.1177/17562848251314801
Efficacy and cost-effectiveness analysis of 10-day versus 14-day eradication of Helicobacter pylori infection with vonoprazan amoxicillin: a prospective, multicenter, randomized controlled trial.
Dong Y, Duan Z, Liu M, Ding Y, et al · · 2025 · cited 1× · PMID 40196374 · DOI 10.3389/fphar.2025.1543352
Assessing the non-inferiority of a 10-day compared with a 14-day vonoprazan-amoxicillin dual therapy regimen for H. pylori eradication: a systematic review and meta-analysis.
Zrineh A, Akwan R, Elsharkawy MM, Mahmoud MAT, et al · · 2026 · PMID 41820859 · DOI 10.1186/s12879-026-13085-0

Verify or expand the search:

Other trials of Vonoprazan

Trials testing the same drug.

NCT06953986 — A Randomized, Three-Arm Study Comparing Vonaprazan 10 mg, Vonaprazan 20 mg, and Esomeprazole 40 mg for the Healing of LA · NA · recruiting
NCT06955520 — Vonaprazan Versus Esomeprazole for Healing of LA Grade B or Higher Esophagitis After POEM · NA · recruiting
NCT07068607 — Efficacy Comparison of Vonoprazan Combined With Different Antibiotics in Dual Therapy for Helicobacter Pylori Eradicatio · Phase 4 · recruiting
NCT07242456 — Head-to-head Study of Tegoprazan 50 mg BID Plus Amoxicillin 1 g TID vs. Vonoprazan 20 mg BID Plus Amoxicillin 1 g TID fo · Phase 2, PHASE3 · recruiting
NCT06811207 — Comparison of the Efficacies of Two Novel Dose Dual Therapies in the First-line Helicobacter Pylori Eradication · Phase 3 · unknown

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 Nanjing First Hospital, Nanjing Medical University trials

Trials by the same sponsor.

NCT07349979 — PCI With Guideline-Directed Medical Therapy for HFpEF Patients With Ischemic Cardiomyopathy · NA · not yet recruiting
NCT07505056 — Jianpi Lishi Jiedu Granules for Prevention of Postoperative Recurrence in Colorectal Advanced Adenomas · Phase 3 · not yet recruiting
NCT07397234 — Thyroid Cartilage Plane VS Superior Laryngeal Nerve Space Block in Awake Tracheal Intubation · NA · not yet recruiting
NCT07455448 — Antibiotic Resistance of Helicobacter Pylori in Nanjing: A Cross-Sectional Study · completed
NCT07385885 — Ultrasound-guided Non-invasive Simulation in Anesthesia Residency Training · NA · 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 NCT05469685 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 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 Nanjing First Hospital, Nanjing Medical University
Last refreshed: 13 June 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/NCT05469685.

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