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Comparison Between Ten Days Sequential Treatment and Traditional Three Combined Treatment of Helicobacter Pylori

Information source: Buddhist Tzu Chi General Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Helicobacter Pylori Infection

Intervention: 5RA-5RCM (Drug); 5RA-5RCT (Drug); 10RCA (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Buddhist Tzu Chi General Hospital

Official(s) and/or principal investigator(s):
Ming-Cheh CHEN, MD, Principal Investigator, Affiliation: Buddhist Tzu Chi General Hospital


The purpose of this study is to compare the eradication efficacy of 10-day triple therapy with 10-day sequential therapy with tetracycline or metronidazole.

Clinical Details

Official title: Comparison Between Ten Days Sequential Treatment (With Metronidazole or Tetracycline) and Ten Days Standard Triple Therapy of Helicobacter Pylori

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Eradication rate

Detailed description: Background: Antimicrobial resistance has decreased eradication rates for Helicobacter pylori infection worldwide. Objective: To determine whether sequential treatment eradicates H. pylori infection better than standard triple-drug therapy for adults with dyspepsia or peptic ulcers in Taiwanese people. Design: Randomized, single-blind, prospective controlled trial. Setting: A large tertiary referral hospital in eastern Taiwan. Patients: 450 patients with dyspepsia or peptic ulcers and infected by H. pylori. Measurements: 13C-urea breath test, upper endoscopy, histologic evaluation, rapid urease test, bacterial culture, assessment of antibiotic resistance and CYP2C19 genotype of host. Intervention: 450 patients with H. pylori infection are randomly assigned to receive one of the following therapeutic schemes: group A (5RA5RCT): rabeprazole (20 mg bid) plus amoxicillin (1 g bid) for 5 days, followed by rabeprazole (20 mg bid) plus clarithromycin (500 mg bid) and tetracycline (1g bid) for a further 5 days; group B (5RA5RCM): rabeprazole (20 mg bid) plus amoxicillin (1 g bid) for 5 days, followed by rabeprazole (20 mg bid) plus clarithromycin (500 mg bid) and metronidazole (500mg bid) for a further 5 days; group C as control: rabeprazole (20 mg bid) plus amoxicillin (1 g bid) and clarithromycin (500 mg bid.) for 10 days.


Minimum age: 20 Years. Maximum age: 95 Years. Gender(s): Both.


Inclusion Criteria:

- patient proved with infection of H. pylori in gastric mucosa

- adult with signed inform consent

Exclusion Criteria:

- woman in breast feeding or pregnancy.

- allergy to drugs used in study.

- three months without use of any antibiotic agents.

- patients under 20 years old.

Locations and Contacts

Buddhist Tzu Chi General Hospital, Hualien 97002, Taiwan
Additional Information

Related publications:

Graham DY, Abudayyeh S, El-Zimaity HM, Hoffman J, Reddy R, Opekun AR. Sequential therapy using high-dose esomeprazole-amoxicillin followed by gatifloxacin for Helicobacter pylori infection. Aliment Pharmacol Ther. 2006 Sep 1;24(5):845-50.

Jafri NS, Hornung CA, Howden CW. Meta-analysis: sequential therapy appears superior to standard therapy for Helicobacter pylori infection in patients naive to treatment. Ann Intern Med. 2008 Jun 17;148(12):923-31. Epub 2008 May 19. Erratum in: Ann Intern Med. 2008 Sep 16;149(6):439.

Vaira D, Zullo A, Vakil N, Gatta L, Ricci C, Perna F, Hassan C, Bernabucci V, Tampieri A, Morini S. Sequential therapy versus standard triple-drug therapy for Helicobacter pylori eradication: a randomized trial. Ann Intern Med. 2007 Apr 17;146(8):556-63.

Choi WH, Park DI, Oh SJ, Baek YH, Hong CH, Hong EJ, Song MJ, Park SK, Park JH, Kim HJ, Cho YK, Sohn CI, Jeon WK, Kim BI. [Effectiveness of 10 day-sequential therapy for Helicobacter pylori eradication in Korea]. Korean J Gastroenterol. 2008 May;51(5):280-4. Korean.

Starting date: January 2009
Last updated: April 9, 2012

Page last updated: August 23, 2015

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