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NCT02827942
Comparison of Vonoprazan-based Dual and Triple Therapies for H. Pylori Eradication
Phase 3 trial testing vonoprazan 20 mg bid in Gastritis Associated With Helicobacter Pylori in 112 participants. Completed in 31 March 2019.
31 December 2018
Quick facts
| Lead sponsor | Hamamatsu University |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 112 |
| Start date | 1 July 2016 |
| Primary completion | 31 December 2018 |
| Estimated completion | 31 March 2019 |
| Sites | 1 location across Japan |
Drugs / interventions tested
- vonoprazan 20 mg bid — full drug profile →
- Amoxicillin 500 mg tid — full drug profile →
- Amoxicillin 750 mg bid — full drug profile →
- Clarithromycin 200 mg bid — full drug profile →
- Metronidazole 250 mg bid — full drug profile →
Conditions studied
- Gastritis Associated With Helicobacter Pylori — all drugs for Gastritis Associated With Helicobacter Pylori →
Sponsor
Hamamatsu University
Who can join
Adults 20 to 90, any sex, with Gastritis Associated With Helicobacter Pylori. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Patients infected with H. pylori were randomly assigned to the dual therapy with vonoprazan 20 mg bid and amoxicillin 500 mg tid for 1 week or the triple therapy with vonoprazan 20 mg bid, amoxicillin 750 mg bid and clarithromycin 200 mg or metronidazole 250 mg bid bid for 1 week. Success or failure of eradication was determined by the 13C-urea breath test performed at 1 month after the therapy.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Clinical Implications of Proton Pump Inhibitors and Vonoprazan Micro/Nano Drug Delivery Systems for Gastric Acid-Related Disorders and Imaging.
Setia A, Challa RR, Vallamkonda B, Vaishali, et al · · 2024 · cited 3× · PMID 39507107 · DOI 10.7150/ntno.100727
Verify or expand the search:
- PubMed search for NCT02827942
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Gastritis Associated With Helicobacter Pylori
Currently open trials in the same condition.
- NCT07245095 — Premedication With N-acetylcysteine and Simethicone to Improve Mucosal Visualization in Elective Upper Endoscopy · Phase 2 · recruiting
- NCT07179237 — Efficacy of Carminal in Helicobacter Pylori Gastritis · Phase 2 · recruiting
Other Hamamatsu University trials
Trials by the same sponsor.
- NCT03466671 — A Trial of TTA-121 on Autism Spectrum Disorder · Phase 2 · unknown
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 NCT02827942 (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 Hamamatsu University
- Last refreshed: 9 April 2019
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/NCT02827942.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing