Tailored Treatment of H. Pylori Infection Based Polymorphisms of CYP2C19 and 23S rRNA of H. Pylori

NCT00149084 | Unknown Phase 3

• 1 other identifier: Hp.CYP.001
• Study Type: interventional
• Target: 296
• Locations: 1 country
• Sites: 1

Brief Summary

The eradication rate of the standard H. pylori eradication therapy (such as the triple therapy with a proton pump inhibitor \[PPI\], amoxicillin and clarithromycin) depends on bacterial susceptibility to clarithromycin and genotypes of CYP2C19 in patients. The investigators intend to investigate whether the tailored therapy based on the two above-mentioned factors increases the cure rate of the initial eradication therapy.

Conditions

Helicobacter Infections; Gastritis; Gastric Ulcer; Duodenal Ulcer

Keywords

The tailored H. pylori eradication therapy; CYP2C19 genotype; 23S rRNA; clarithromycin; Lansoprazole; Amoxicillin; H. pylori infection

Outcome Measures

Primary Outcomes (1)

• Whether the tailored treatment yields a higher eradication rate in comparison with the standard treatment

Secondary Outcomes (1)

• Cost-effectiveness of the tailored strategy

Interventions

Lansoprazole, clarithromycin, amoxicillin DRUG

Eligibility Criteria

• Age: 15 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with H. pylori infection

You may not qualify if:

• Patients without H. pylori infection

Sponsors & Collaborators

• Hamamatsu University: lead
• Yokoyama Foundation for Clinical Pharmacology: collaborator

Study Sites (1)

Hamamatsu University School of Medicine

Hamamatsu, Shizuoka, 431-3192, Japan

RECRUITING

Related Publications (12)

• Furuta T, Shirai N, Sugimoto M, Nakamura A, Hishida A, Ishizaki T. Influence of CYP2C19 pharmacogenetic polymorphism on proton pump inhibitor-based therapies. Drug Metab Pharmacokinet. 2005 Jun;20(3):153-67. doi: 10.2133/dmpk.20.153.

  PMID: 15988117 BACKGROUND

• Furuta T, Sagehashi Y, Shirai N, Sugimoto M, Nakamura A, Kodaira M, Kenmotsu K, Nagano M, Egashira T, Ueda K, Yoneyama M, Ohashi K, Ishizaki T, Hishida A. Influence of CYP2C19 polymorphism and Helicobacter pylori genotype determined from gastric tissue samples on response to triple therapy for H pylori infection. Clin Gastroenterol Hepatol. 2005 Jun;3(6):564-73. doi: 10.1016/s1542-3565(04)00779-7.

  PMID: 15952098 BACKGROUND

• Furuta T, Shirai N, Sugimoto M, Ohashi K, Ishizaki T. Pharmacogenomics of proton pump inhibitors. Pharmacogenomics. 2004 Mar;5(2):181-202. doi: 10.1517/phgs.5.2.181.27483.

  PMID: 15016609 BACKGROUND

• Sugimoto M, Furuta T, Shirai N, Kajimura M, Hishida A, Sakurai M, Ohashi K, Ishizaki T. Different dosage regimens of rabeprazole for nocturnal gastric acid inhibition in relation to cytochrome P450 2C19 genotype status. Clin Pharmacol Ther. 2004 Oct;76(4):290-301. doi: 10.1016/j.clpt.2004.06.008.

  PMID: 15470328 BACKGROUND

• Furuta T, Shirai N, Xiao F, Takashita M, Sugimoto M, Kajimura M, Ohashi K, Ishizaki T. High-dose rabeprazole/amoxicillin therapy as the second-line regimen after failure to eradicate H. pylori by triple therapy with the usual doses of a proton pump inhibitor, clarithromycin and amoxicillin. Hepatogastroenterology. 2003 Nov-Dec;50(54):2274-8.

  PMID: 14696516 BACKGROUND

• Furuta T, Shirai N, Ohashi K, Ishizaki T. Therapeutic impact of CYP2C19 pharmacogenetics on proton pump inhibitor-based eradication therapy for Helicobacter pylori. Methods Find Exp Clin Pharmacol. 2003 Mar;25(2):131-43. doi: 10.1358/mf.2003.25.2.723687.

  PMID: 12731459 BACKGROUND

• Furuta T, Shirai N, Xiao F, Ohashi K, Ishizaki T. Effect of high-dose lansoprazole on intragastic pH in subjects who are homozygous extensive metabolizers of cytochrome P4502C19. Clin Pharmacol Ther. 2001 Nov;70(5):484-92. doi: 10.1067/mcp.2001.119721.

  PMID: 11719736 BACKGROUND

• Furuta T, Shirai N, Takashima M, Xiao F, Hanai H, Nakagawa K, Sugimura H, Ohashi K, Ishizaki T. Effects of genotypic differences in CYP2C19 status on cure rates for Helicobacter pylori infection by dual therapy with rabeprazole plus amoxicillin. Pharmacogenetics. 2001 Jun;11(4):341-8. doi: 10.1097/00008571-200106000-00009.

  PMID: 11434512 BACKGROUND

• Furuta T, Shirai N, Takashima M, Xiao F, Hanai H, Sugimura H, Ohashi K, Ishizaki T, Kaneko E. Effect of genotypic differences in CYP2C19 on cure rates for Helicobacter pylori infection by triple therapy with a proton pump inhibitor, amoxicillin, and clarithromycin. Clin Pharmacol Ther. 2001 Mar;69(3):158-68. doi: 10.1067/mcp.2001.113959.

  PMID: 11240980 BACKGROUND

• Furuta T, Takashima M, Shirai N, Xiao F, Hanai H, Ohashi K, Ishizaki T. Cure of refractory duodenal ulcer and infection caused by Helicobacter pylori by high doses of omeprazole and amoxicillin in a homozygous CYP2C19 extensive metabolizer patient. Clin Pharmacol Ther. 2000 Jun;67(6):684-9. doi: 10.1067/mcp.2000.106826.

  PMID: 10872651 BACKGROUND

• Furuta T, Ohashi K, Kosuge K, Zhao XJ, Takashima M, Kimura M, Nishimoto M, Hanai H, Kaneko E, Ishizaki T. CYP2C19 genotype status and effect of omeprazole on intragastric pH in humans. Clin Pharmacol Ther. 1999 May;65(5):552-61. doi: 10.1016/S0009-9236(99)70075-5.

  PMID: 10340921 BACKGROUND

• Furuta T, Ohashi K, Kamata T, Takashima M, Kosuge K, Kawasaki T, Hanai H, Kubota T, Ishizaki T, Kaneko E. Effect of genetic differences in omeprazole metabolism on cure rates for Helicobacter pylori infection and peptic ulcer. Ann Intern Med. 1998 Dec 15;129(12):1027-30. doi: 10.7326/0003-4819-129-12-199812150-00006.

  PMID: 9867757 BACKGROUND

MeSH Terms

Conditions

Helicobacter Infections; Gastritis; Stomach Ulcer; Duodenal Ulcer

Interventions

Lansoprazole; Clarithromycin; Amoxicillin

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases; Peptic Ulcer; Duodenal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Erythromycin; Macrolides; Polyketides; Lactones; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides

Study Officials

• Takahisa Furuta, MD, PhD

  Center for Clinical Research, Hamamatsu University School of Medicine

  STUDY CHAIR

Central Study Contacts

Takahisa Furuta, MD PhD

CONTACT

81-53-435-2850; furuta@hama-med.ac.jp

Naohito Shirai, MD, PhD

CONTACT

naohito@hama-med.ac.jp

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 6, 2005
• First Posted: September 8, 2005
• Study Start: April 1, 2003
• Last Updated: September 11, 2006

Record last verified: 2005-09

Locations

JP (1)