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NCT04678492
Helicobacter Rescue Therapy With High-dose Esomeprazole and Amoxicillin Dual Therapy Versus Bismuth-containing Quadruple Therapy
Phase 4 trial testing Esomeprazole in Gastritis in 658 participants. Completed in 20 December 2021.
20 December 2021
Quick facts
| Lead sponsor | Xijing Hospital of Digestive Diseases |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 658 |
| Start date | 20 December 2020 |
| Primary completion | 20 December 2021 |
| Estimated completion | 20 December 2021 |
| Sites | 1 location across China |
Drugs / interventions tested
- Esomeprazole (esomeprazole) — full drug profile →
- Amoxicillin (amoxicillin) — full drug profile →
- Bismuth
- Esomeprazole (esomeprazole) — full drug profile →
- Tetracycline — full drug profile →
- Furazolidone (FURAZOLIDONE) — full drug profile →
Conditions studied
- Gastritis — all drugs for Gastritis →
- Dyspepsia — all drugs for Dyspepsia →
- Helicobacter Pylori Infection — all drugs for Helicobacter Pylori Infection →
- Gastric Cancer — all drugs for Gastric Cancer →
Sponsor
Xijing Hospital of Digestive Diseases
Who can join
Adults 18 to 70, any sex, with Gastritis or Dyspepsia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study aims at evaluating efficacy and safety of high-dose esomeprazole and amoxicillin dual therapy(esomeprazole and amoxicillin) versus bismuth-containing quadruple Therapy(bismuth，esomeprazole，tetracycline and furazolidone) in H. pylori rescue therapy. It is hypothesized that high-dose esomeprazole and amoxicillin dual therapy is non-inferior to bismuth-containing quadruple Therapy. Patients with confirmed failure of H. pylori eradication will be randomized to one of the treatments described above. At week 6 follow-up visits, a urea breath test，rapid urease test or helicobacter pylori stool antigen test will be performed to confirm eradication.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Efficacy and safety of high-dose esomeprazole-amoxicillin dual therapy for Helicobacter pylori rescue treatment: a multicenter, prospective, randomized, controlled trial.
Bi H, Chen X, Chen Y, Zhao X, et al · · 2022 · cited 24× · PMID 36193978 · DOI 10.1097/cm9.0000000000002289
Verify or expand the search:
- PubMed search for NCT04678492
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Currently open trials in the same condition.
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Other Xijing Hospital of Digestive Diseases trials
Trials by the same sponsor.
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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 NCT04678492 (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 Xijing Hospital of Digestive Diseases
- Last refreshed: 31 January 2023
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/NCT04678492.
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