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

Not Applicable

Completed

• Conditions: Helicobacter Pylori Infection
• Interventions: Drug: Quadruple therapy; Drug: Triple therapy

• Registration Number: NCT01306786
• Lead Sponsor: The University of Hong Kong

Brief 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.

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.

Study Timeline

• Study Start: 2008-11
• Primary Completion: 2010-10
• Study Completion: 2011-02
• Study First Submitted: 2011-02-24
• Study First Submitted QC: 2011-03-01
• Study First Posted: 2011-03-02
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-26
• Last Update Posted: 2015-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 800

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Quadruple therapy	Quadruple therapy	First line: 5 days esomeprazole 20mg b.d., bismuth subcitrate 120mg q.i.d., tetracycline 250mg q.i.d. and metronidazole 250mg q.i.d. Cross over second line for those who failed first line: 7 days esomeprazole 20mg b.d., amoxicillin 1g b.d. and clarithromycin 500mg b.d
Triple Therapy	Triple therapy	First line: 7 days esomeprazole 20mg b.d., amoxicillin 1g b.d. and clarithromycin 500mg b.d Second line cross over if failed first line: 7 days quadruple therapy: esomeprazole 20mg b.d., bismuth subcitrate 120mg q.i.d., tetracycline 250mg q.i.d. and metronidazole 250mg q.i.d.)

Primary Outcome Measures

Name	Time	Method
H pylori eradication	8 weeks after treatment	Successful H pylori eradication documented by urea breath test after first and second line treatments. Cross over if patients failed first line treatment

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	10 weeks outpatient follow-up	Assessed adverse effects and compliance by standard questionnaire upon 10 weeks outpatient follow-up

Trial Locations

Locations (1)

The University of Hong Kong, Queen Mary Hospital; 🇭🇰 Hong Kong SAR, Hong Kong