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

This study has been completed.
Sponsor:
Information provided by:
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01306786
First received: February 24, 2011
Last updated: March 1, 2011
Last verified: March 2011
History of Changes
  Purpose

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.


Condition Intervention
Bacterial Infection Due to Helicobacter Pylori (H. Pylori)
 Drug: Quadruple therapy
Drug: Triple therapy

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • H pylori eradication [ Time Frame: 8 weeks after treatment ] [ Designated as safety issue: No ]
    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:
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 10 weeks outpatient follow-up ] [ Designated as safety issue: Yes ]
    Assessed adverse effects and compliance by standard questionnaire upon 10 weeks outpatient follow-up


Enrollment: 800
Study Start Date: November 2008
Study Completion Date: February 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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

 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
Active Comparator: 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.)
 Drug: 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.)

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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01306786

Locations
China
The University of Hong Kong, Queen Mary Hospital
Hong Kong SAR, China
Sponsors and Collaborators
The University of Hong Kong
Investigators
Principal Investigator: Ivan F Hung, MD MRCP The University of Hong Kong
  More Information

No publications provided

Responsible Party: Dr Ivan FN Hung, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01306786     History of Changes
Other Study ID Numbers: HKU-HP1
Study First Received: February 24, 2011
Last Updated: March 1, 2011
Health Authority: Hong Kong: Ethics Committee

Additional relevant MeSH terms:
Bacterial Infections
Metronidazole
Bismuth tripotassium dicitrate
Clarithromycin
Omeprazole
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Infective Agents
Therapeutic Uses
 Antiprotozoal Agents
Antiparasitic Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Synthesis Inhibitors
Anti-Bacterial Agents
Antacids

ClinicalTrials.gov processed this record on May 16, 2013