Clinical trial NCT06318104 - References

Helicobacter Pylori Infection — Efficacy and Safety of a Triple Eradication Scheme for Helicobacter Pylori Based on Tegoprazan vs Esomeprazole

Citation(s)

•   Alarcon-Millan J, Fernandez-Tilapa G, Cortes-Malagon EM, Castanon-Sanchez CA, De Sampedro-Reyes J, Cruz-Del Carmen I, Betancourt-Linares R, Roman-Roman A
  Clarithromycin resistance and prevalence of Helicobacter pylori virulent genotypes in patients from Southern Mexico with chronic gastritis. Infect Genet Evol. 2016 Oct;44:190-198. doi: 10.1016/j.meegid.2016.06.044. Epub 2016 Jun 26.
•   Bosques-Padilla FJ, Remes-Troche JM, Gonzalez-Huezo MS, Perez-Perez G, Torres-Lopez J, Abdo-Francis JM, Bielsa-Fernandez MV, Camargo MC, Esquivel-Ayanegui F, Garza-Gonzalez E, Hernandez-Guerrero AI, Herrera-Goepfert R, Huerta-Iga FM, Leal-Herrera Y, Lopez-Colombo A, Ortiz-Olvera NX, Riquelme-Perez A, Sampieri CL, Uscanga-Dominguez LF, Velarde-Ruiz Velasco JA
  The fourth Mexican consensus on Helicobacter pylori. Rev Gastroenterol Mex (Engl Ed). 2018 Jul-Sep;83(3):325-341. doi: 10.1016/j.rgmx.2018.05.003. Epub 2018 Jun 22. English, Spanish.
•   Chey WD, Leontiadis GI, Howden CW, Moss SF
  ACG Clinical Guideline: Treatment of Helicobacter pylori Infection. Am J Gastroenterol. 2017 Feb;112(2):212-239. doi: 10.1038/ajg.2016.563. Epub 2017 Jan 10. Erratum In: Am J Gastroenterol. 2018 Jul;113(7):1102.
•   Choi YJ, Lee YC, Kim JM, Kim JI, Moon JS, Lim YJ, Baik GH, Son BK, Lee HL, Kim KO, Kim N, Ko KH, Jung HK, Shim KN, Chun HJ, Kim BW, Lee H, Kim JH, Chung H, Kim SG, Jang JY
  Triple Therapy-Based on Tegoprazan, a New Potassium-Competitive Acid Blocker, for First-Line Treatment of Helicobacter pylori Infection: A Randomized, Double-Blind, Phase III, Clinical Trial. Gut Liver. 2022 Jul 15;16(4):535-546. doi: 10.5009/gnl220055. Epub 2022 Jul 6.
•   Domingues G, Chinzon D, Moraes-Filho JPP, Senra JT, Perrotti M, Zaterka S
  Potassium-competitive acid blockers, a new therapeutic class, and their role in acid-related diseases: a narrative review. Prz Gastroenterol. 2023;18(1):47-55. doi: 10.5114/pg.2022.116673. Epub 2022 Aug 15.
•   Echizen H
  The First-in-Class Potassium-Competitive Acid Blocker, Vonoprazan Fumarate: Pharmacokinetic and Pharmacodynamic Considerations. Clin Pharmacokinet. 2016 Apr;55(4):409-18. doi: 10.1007/s40262-015-0326-7.
•   Gatta L, Vakil N, Vaira D, Scarpignato C
  Global eradication rates for Helicobacter pylori infection: systematic review and meta-analysis of sequential therapy. BMJ. 2013 Aug 7;347:f4587. doi: 10.1136/bmj.f4587.
•   Kato M, Ota H, Okuda M, Kikuchi S, Satoh K, Shimoyama T, Suzuki H, Handa O, Furuta T, Mabe K, Murakami K, Sugiyama T, Uemura N, Takahashi S
  Guidelines for the management of Helicobacter pylori infection in Japan: 2016 Revised Edition. Helicobacter. 2019 Aug;24(4):e12597. doi: 10.1111/hel.12597. Epub 2019 May 20.
•   Leja M, Grinberga-Derica I, Bilgilier C, Steininger C
  Review: Epidemiology of Helicobacter pylori infection. Helicobacter. 2019 Sep;24 Suppl 1:e12635. doi: 10.1111/hel.12635.
•   Li Q
  Bacterial infection and microbiota in carcinogenesis and tumor development. Front Cell Infect Microbiol. 2023 Nov 15;13:1294082. doi: 10.3389/fcimb.2023.1294082. eCollection 2023.
•   Lima JJ, Thomas CD, Barbarino J, Desta Z, Van Driest SL, El Rouby N, Johnson JA, Cavallari LH, Shakhnovich V, Thacker DL, Scott SA, Schwab M, Uppugunduri CRS, Formea CM, Franciosi JP, Sangkuhl K, Gaedigk A, Klein TE, Gammal RS, Furuta T
  Clinical Pharmacogenetics Implementation Consortium (CPIC) Guideline for CYP2C19 and Proton Pump Inhibitor Dosing. Clin Pharmacol Ther. 2021 Jun;109(6):1417-1423. doi: 10.1002/cpt.2015. Epub 2020 Sep 20.
•   Luo S, Ru J, Khan Mirzaei M, Xue J, Peng X, Ralser A, Hadi JL, Mejias-Luque R, Gerhard M, Deng L
  Helicobacter pylori infection alters gut virome by expanding temperate phages linked to increased risk of colorectal cancer. Gut. 2023 Nov 2:gutjnl-2023-330362. doi: 10.1136/gutjnl-2023-330362. Online ahead of print. No abstract available.
•   Malfertheiner P, Camargo MC, El-Omar E, Liou JM, Peek R, Schulz C, Smith SI, Suerbaum S
  Helicobacter pylori infection. Nat Rev Dis Primers. 2023 Apr 20;9(1):19. doi: 10.1038/s41572-023-00431-8.
•   Malfertheiner P, Megraud F, Rokkas T, Gisbert JP, Liou JM, Schulz C, Gasbarrini A, Hunt RH, Leja M, O'Morain C, Rugge M, Suerbaum S, Tilg H, Sugano K, El-Omar EM; European Helicobacter and Microbiota Study group
  Management of Helicobacter pylori infection: the Maastricht VI/Florence consensus report. Gut. 2022 Aug 8:gutjnl-2022-327745. doi: 10.1136/gutjnl-2022-327745. Online ahead of print.
•   Mladenova I
  Epidemiology of Helicobacter pylori Resistance to Antibiotics (A Narrative Review). Antibiotics (Basel). 2023 Jul 13;12(7):1184. doi: 10.3390/antibiotics12071184.
•   Murakami K, Sakurai Y, Shiino M, Funao N, Nishimura A, Asaka M
  Vonoprazan, a novel potassium-competitive acid blocker, as a component of first-line and second-line triple therapy for Helicobacter pylori eradication: a phase III, randomised, double-blind study. Gut. 2016 Sep;65(9):1439-46. doi: 10.1136/gutjnl-2015-311304. Epub 2016 Mar 2.
•   Ng HY, Leung WK, Cheung KS
  Antibiotic Resistance, Susceptibility Testing and Stewardship in Helicobacter pylori Infection. Int J Mol Sci. 2023 Jul 20;24(14):11708. doi: 10.3390/ijms241411708.
•   Okamura T, Suga T, Nagaya T, Arakura N, Matsumoto T, Nakayama Y, Tanaka E
  Antimicrobial resistance and characteristics of eradication therapy of Helicobacter pylori in Japan: a multi-generational comparison. Helicobacter. 2014 Jun;19(3):214-20. doi: 10.1111/hel.12124. Epub 2014 Apr 3.
•   Porras C, Nodora J, Sexton R, Ferreccio C, Jimenez S, Dominguez RL, Cook P, Anderson G, Morgan DR, Baker LH, Greenberg ER, Herrero R
  Epidemiology of Helicobacter pylori infection in six Latin American countries (SWOG Trial S0701). Cancer Causes Control. 2013 Feb;24(2):209-15. doi: 10.1007/s10552-012-0117-5. Epub 2012 Dec 12.
•   Sakurai Y, Nishimura A, Kennedy G, Hibberd M, Jenkins R, Okamoto H, Yoneyama T, Jenkins H, Ashida K, Irie S, Taubel J
  Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Rising TAK-438 (Vonoprazan) Doses in Healthy Male Japanese/non-Japanese Subjects. Clin Transl Gastroenterol. 2015 Jun 25;6(6):e94. doi: 10.1038/ctg.2015.18.
•   Savoldi A, Carrara E, Graham DY, Conti M, Tacconelli E
  Prevalence of Antibiotic Resistance in Helicobacter pylori: A Systematic Review and Meta-analysis in World Health Organization Regions. Gastroenterology. 2018 Nov;155(5):1372-1382.e17. doi: 10.1053/j.gastro.2018.07.007. Epub 2018 Jul 7.
•   Shah A, Usman O, Zahra T, Chaudhari SS, Mulaka GSR, Masood R, Batool S, Saleem F
  Efficacy and Safety of Potassium-Competitive Acid Blockers Versus Proton Pump Inhibitors as Helicobacter pylori Eradication Therapy: A Meta-Analysis of Randomized Clinical Trials. Cureus. 2023 Nov 7;15(11):e48465. doi: 10.7759/cureus.48465. eCollection 2023 Nov.
•   Shah SC, Iyer PG, Moss SF
  AGA Clinical Practice Update on the Management of Refractory Helicobacter pylori Infection: Expert Review. Gastroenterology. 2021 Apr;160(5):1831-1841. doi: 10.1053/j.gastro.2020.11.059. Epub 2021 Jan 29.
•   Shakir SM, Shakir FA, Couturier MR
  Updates to the Diagnosis and Clinical Management of Helicobacter pylori Infections. Clin Chem. 2023 Aug 2;69(8):869-880. doi: 10.1093/clinchem/hvad081. Erratum In: Clin Chem. 2023 Dec 1;69(12):1437.
•   Sugimoto M, Furuta T
  Efficacy of tailored Helicobacter pylori eradication therapy based on antibiotic susceptibility and CYP2C19 genotype. World J Gastroenterol. 2014 Jun 7;20(21):6400-11. doi: 10.3748/wjg.v20.i21.6400.
•   Sun Q, Yuan C, Zhou S, Lu J, Zeng M, Cai X, Song H
  Helicobacter pylori infection: a dynamic process from diagnosis to treatment. Front Cell Infect Microbiol. 2023 Oct 19;13:1257817. doi: 10.3389/fcimb.2023.1257817. eCollection 2023.
•   Torres J, Camorlinga-Ponce M, Perez-Perez G, Madrazo-De la Garza A, Dehesa M, Gonzalez-Valencia G, Munoz O
  Increasing multidrug resistance in Helicobacter pylori strains isolated from children and adults in Mexico. J Clin Microbiol. 2001 Jul;39(7):2677-80. doi: 10.1128/JCM.39.7.2677-2680.2001.
•   Torres J, Ferreira RM, Kato I
  Editorial: The role of Helicobacter pylori in gastric carcinogenesis. Front Oncol. 2023 Jun 26;13:1233890. doi: 10.3389/fonc.2023.1233890. eCollection 2023. No abstract available.
•   World gastroenterology organisation global guideline: Helicobacter pylori in developing countries
  J Dig Dis. 2011 Oct;12(5):319-26. doi: 10.1111/j.1751-2980.2011.00529.x. No abstract available.
•   Zhou BG, Yan XL, Wan LY, Zhang Q, Li B, Ai YW
  Effect of enhanced patient instructions on Helicobacter pylori eradication: A systematic review and meta-analysis of randomized controlled trials. Helicobacter. 2022 Apr;27(2):e12869. doi: 10.1111/hel.12869. Epub 2022 Feb 18. Erratum In: Helicobacter. 2022 Jun;27(3):e12892.

Efficacy and Safety of a Triple Eradication Scheme for Helicobacter Pylori Based on Amoxicillin 1g + Clarithromycin 500 mg and Tegoprazan 50 mg vs Amoxicillin 1g + Clarithromycin 500 mg and Esomeprazole 40 mg Twice a Day for 14 Days

Details for clinical trial NCT06318104