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

NCT01306786 | Completed DMC

• 1 other identifier: HKU-HP1
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Helicobacter Pylori Infection

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  10 weeks outpatient follow-up

Study Arms (2)

Quadruple therapy

ACTIVE COMPARATOR

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

Drug: Quadruple therapy

Triple Therapy

ACTIVE COMPARATOR

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.)

Drug: Triple therapy

Interventions

Quadruple therapy DRUG

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

Quadruple therapy

Triple therapy DRUG

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.)

Triple Therapy

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with H. pylori infection
• did not receive H. pylori eradication therapy before

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong, Queen Mary Hospital

Hong Kong SAR, Hong Kong

Location

Study Officials

• Ivan F Hung, MD MRCP

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: February 24, 2011
• First Posted: March 2, 2011
• Study Start: November 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: February 1, 2011
• Last Updated: May 28, 2015

Record last verified: 2015-05

Locations

HK (1)