drugset / Trial / NCT05870683
Comparison of Two Dual Therapies in the First-line Treatment of Helicobacter Pylori Infection (SHARE2301)
Unknown
368 enrolled
Yanqing Li
Linyi People's Hospital · collabShandong University of Traditional Chinese Medicine · collabThe Affiliated Hospital of Qingdao University · collabThe People's Hospital of Jimo · collabWeifang Medical University · collabYuncheng Traditional Chinese Medicine Hospital · collabZhengzhou Central Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Helicobacter pylori (H. pylori) infection is a common global infectious disease of the gastrointestinal tract. Helicobacter pylori eradication can effectively prevent the development of stomach cancer. Progressive application of dual therapy for the eradication of Helicobacter pylori. Tegoprazan, a Potassium-Competitive Acid Blockers. The efficacy of P-CAB agents represented by vonoprazan in H. pylori eradication therapy has been widely verified.
Timeline
- Start
- 2023-05-24
- Primary completion
- 2023-10-01
- Completion
- 2023-12-30
Outcome
Met primary endpoint
paper The eradication rates for the TA group were not inferior to those of the EA group in both PP (p = 0.0023) and ITT analyses (p = 0.0009). PMID 38853394 ↗
Publications
- Results Malfertheiner P, Megraud F, O'Morain CA, Gisbert JP, Kuipers EJ, Axon AT, Bazzoli F, Gasbarrini A, Atherton J, Graham DY, Hunt R, Moayyedi P, Rokkas T, Rugge M, Selgrad M, Suerbaum S, Sugano K, El-Omar EM; European Helicobacter and Microbiota Study Group and Consensus panel. Management of Helicobacter pylori infection-the Maastricht V/Florence Consensus Report. Gut. 2017 Jan;66(1):6-30. doi: 10.1136/gutjnl-2016-312288. Epub 2016 Oct 5.
- Kong Q, Mirza IA, Zhang X, Song X, Li X, Zhang Q, Xu L, Guo Y, Yu Y, Zuo X, Li Y, Li Y. Fourteen-Day Tegoprazan-Amoxicillin Dual Therapy as the First-Line Treatment of Helicobacter pylori Infection (SHARE2301): A Multicenter, Noninferiority, Randomized Clinical Trial. Helicobacter. 2024 May-Jun;29(3):e13098. doi: 10.1111/hel.13098.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Esomeprazole | Small molecule | 20 mg | — |
| Subject | Tegoprazan | Other / unclassified | 50 mg | — |
| Background | Amoxicillin | Other / unclassified | 750 mg | — |