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

Helicobacter Pylori Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01306786
• Other study ID #: HKU-HP1
• Status: Completed
• Phase: N/A
• First received: February 24, 2011
• Last updated: May 26, 2015
• Start date: November 2008
• Est. completion date: February 2011

Study information

• Verified date: May 2015
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: February 2011
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Helicobacter Infections
• Helicobacter Pylori Infection

Intervention

Drug:
• 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
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.)

Locations

Country	Name	City	State
Hong Kong	The University of Hong Kong, Queen Mary Hospital	Hong Kong SAR

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	H pylori eradication	Successful H pylori eradication documented by urea breath test after first and second line treatments. Cross over if patients failed first line treatment	8 weeks after treatment	No
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability	Assessed adverse effects and compliance by standard questionnaire upon 10 weeks outpatient follow-up	10 weeks outpatient follow-up	Yes