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Five Days Quadruple and Clarithromycin Containing Triple Therapy as Treatment for Helicobacter Pylori Eradication

Information source: The University of Hong Kong
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Helicobacter Pylori Infection

Intervention: Quadruple therapy (Drug); Triple therapy (Drug)

Phase: N/A

Status: Completed

Sponsored by: The University of Hong Kong

Official(s) and/or principal investigator(s):
Ivan F Hung, MD MRCP, Principal Investigator, Affiliation: The University of Hong Kong

Summary

The aim of this randomized trial is to compare the efficacy and tolerability of H. pylori eradication with a 5-day quadruple therapy versus a clarithromycin-containing triple therapy.

Clinical Details

Official title: Five Days Quadruple and Clarithromycin Containing Triple Therapy as Empirical First and Second-Line Treatment for Helicobacter Pylori Eradication: a Randomized Crossover Trial

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

Primary outcome: H pylori eradication

Secondary outcome: Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Detailed description: Eligible patients with H pylori infection were randomized to receive either five-day QUAD (esomeprazole 20mg b. d., bismuth subcitrate 120mg q. i.d., tetracycline 250mg q. i.d. and metronidazole 250mg q. i.d.) or EAC (esomeprazole 20mg b. d., amoxicillin 1g b. d. and clarithromycin 500mg b. d.). H. pylori status was rechecked by 13C urea breath test 8 weeks after treatment. Patients who failed their respective therapy were invited to undergo H. pylori susceptibility testing and crossover to receive the alternative regimen for the same duration.

Eligibility

Minimum age: 21 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- patients with H. pylori infection

- did not receive H. pylori eradication therapy before

Exclusion Criteria:

- patients who have received previous H. pylori eradication therapy

- co-morbidity of liver cirrhosis

- co-morbidity of renal failure

- co-morbidity of alcoholism

- co-morbidity of malignancy

- received antibiotics, bismuth preparations, proton pump inhibitors or probiotic in

the preceding three months

- patients with known allergy to the medications used

- patients with a history of previous gastrointestinal diseases or gastric surgery

- pregnancy

Locations and Contacts

The University of Hong Kong, Queen Mary Hospital, Hong Kong SAR, Hong Kong
Additional Information

Starting date: November 2008
Last updated: May 26, 2015

Page last updated: August 23, 2015

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