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Quadruple Versus Sequential Therapy for Helicobacter Pylori Eradication

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr Ivan FN Hung, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01760824
First received: December 29, 2012
Last updated: January 2, 2013
Last verified: January 2013
History of Changes
  Purpose

Helicobacter pylori (HP), a bacterium present in many people's stomachs, is one of the major causes of ulcers and cancers. Up to 20% of patients infected with H. pylori may develop peptic ulcers. However, failure rate is rising due to multiple resistant H. pylori infection. The eradication rate of first line clarithromycin based therapy has fallen to below 80%. Both quadruple and sequential treatment regime has been proposed as the first-line empirical regime. Nevertheless, comparison in terms of efficacy and side effects between the two regime remained unknown. The aim of this clinical trial is to compare the efficacy and tolerability of H. pylori eradication with a 10-day quadruple therapy versus sequential therapy as empirical first and second line treatment.


Condition Intervention
Helicobacter Pylori Infection
 Drug: Sequential therapy
Drug: Quadruple therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ten Days Quadruple Versus Sequential 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:
  • Helicobacter pylori eradication rate [ Time Frame: 8 weeks after treatment ] [ Designated as safety issue: No ]
    Percentage of patients successfully eradicated Helicobacter pylori infection confirmed by urea breath test


Secondary Outcome Measures:
  • Development of side effects [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]
    Patients to document side effects during treatment


Enrollment: 391
Study Start Date: May 2011
Study Completion Date: December 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sequential therapy
Esomeprazole 20mg bid for 10 days, amoxicillin 1g bid for first 5 days, clarithromycin 500mg bid for last 5 days and metronidazole 400mg qid for last 5 days
 Drug: Sequential therapy
Esomeprazole 20mg bid for 10 days, amoxicillin 1g bid for first 5 days, clarithromycin 500mg bid for last 5 days and metronidazole 400mg qid for last 5 days
Other Names:
  • Esomeprazole (Nexium) 20mg bid for 10 days
  • Amoxicillin 1g bid for first 5 days
  • Clarithromycin (Klacid) 500mg bid for last 5 days
  • Metronidazole (Flagyl) 400mg qid for last 5 days
Drug: Quadruple therapy
Esomeprazole 20mg bid, metronidazole 400mg qid, bismuth sub citrate 120mg qid and tetracycline 500mg qid, all for 10 days
Other Names:
  • Esomeprazole (Nexium) 20mg bid
  • Metronidazole (Flagyl) 400mg qid
  • Bismuth subcitrate 120mg qid
  • Tetracycline 500mg qid
  • all for 10 days
Active Comparator: Quadruple therapy
Esomeprazole 20mg bid, metronidazole 400mg aid, bismuth sub citrate 120mg aid and tetracycline 500mg qid, all for 10 days
 Drug: Sequential therapy
Esomeprazole 20mg bid for 10 days, amoxicillin 1g bid for first 5 days, clarithromycin 500mg bid for last 5 days and metronidazole 400mg qid for last 5 days
Other Names:
  • Esomeprazole (Nexium) 20mg bid for 10 days
  • Amoxicillin 1g bid for first 5 days
  • Clarithromycin (Klacid) 500mg bid for last 5 days
  • Metronidazole (Flagyl) 400mg qid for last 5 days
Drug: Quadruple therapy
Esomeprazole 20mg bid, metronidazole 400mg qid, bismuth sub citrate 120mg qid and tetracycline 500mg qid, all for 10 days
Other Names:
  • Esomeprazole (Nexium) 20mg bid
  • Metronidazole (Flagyl) 400mg qid
  • Bismuth subcitrate 120mg qid
  • Tetracycline 500mg qid
  • all for 10 days

Detailed Description:

Helicobacter pylori (HP), a bacterium present in many people's stomachs, is one of the major causes of ulcers and cancers. Up to 20% of patients infected with HP may develop peptic ulcers. However, failure rate is rising due to multiple resistant HP infection. The eradication rate of first line clarithromycin based therapy has fell to below 80% and increasing number of patients also failed the second line quadruple therapy. The aim of this clinical trial is to compare the efficacy and tolerability of H. pylori eradication with a 10-day quadruple therapy versus sequential therapy as empirical first and second line treatment.

Methods: Eligible H. pylori positive patients were randomized to receive either QUAD (esomeprazole 20mg twice daily, bismuth subcitrate 120mg four times daily, tetracycline 500mg four times daily and metronidazole 400mg four times daily) for 10 days or SEQ (esomeprazole 20mg twice daily for 10 days, amoxicillin 1g twice daily for first 5 days, clarithromycin 500mg twice daily and metronidazole 400mg four time daily for the subsequent 5 days). All patients returned 8 weeks after completing the treatment for a Urea Breath Test (UBT) to confirm eradication. Patients who failed their respective therapy were crossover to receive the alternative regimen.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with age 18 or above, diagnosed to have gastric HP infection

Exclusion Criteria:

  • Patients with age less than 18, with past allergy to the study medications, concurrent critical illnesses, a history of previous upper gastrointestinal surgery, intake of nonsteroidal anti-inflammatory drugs, antibiotics, probiotics, bismuth preparation, proton pump inhibitors, anticoagulants or steroids in the previous one month, pregnant or breast-feeding women, drug abusers or alcoholic, history of previous H. Pylori treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01760824

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

No publications provided

Responsible Party: Dr Ivan FN Hung, Clinical Associate Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01760824     History of Changes
Other Study ID Numbers: UW 11-221
Study First Received: December 29, 2012
Last Updated: January 2, 2013
Health Authority: Hong Kong: Ethics Committee

Keywords provided by The University of Hong Kong:
Sequential
Quadruple
First
Line
 Helicobacter
pylori
infection

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

ClinicalTrials.gov processed this record on June 18, 2013