Quadruple Versus Sequential Therapy for Helicobacter Pylori Eradication
Primary Purpose
Helicobacter Pylori Infection
Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Sequential therapy
Quadruple therapy
Sponsored by
About this trial
This is an interventional treatment trial for Helicobacter Pylori Infection focused on measuring Sequential, Quadruple, First, Line, Helicobacter, pylori, infection
Eligibility 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
Sites / Locations
- The University of Hong Kong, Queen Mary Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Sequential therapy
Quadruple therapy
Arm Description
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
Esomeprazole 20mg bid, metronidazole 400mg aid, bismuth sub citrate 120mg aid and tetracycline 500mg qid, all for 10 days
Outcomes
Primary Outcome Measures
Helicobacter pylori eradication rate
Percentage of patients successfully eradicated Helicobacter pylori infection confirmed by urea breath test
Secondary Outcome Measures
Development of side effects
Patients to document side effects during treatment
Full Information
NCT ID
NCT01760824
First Posted
December 29, 2012
Last Updated
January 2, 2013
Sponsor
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT01760824
Brief Title
Quadruple Versus Sequential Therapy for Helicobacter Pylori Eradication
Official Title
Ten Days Quadruple Versus Sequential Therapy as Empirical First and Second Line Treatment for Helicobacter Pylori Eradication: a Randomized Crossover Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Pylori Infection
Keywords
Sequential, Quadruple, First, Line, Helicobacter, pylori, infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
391 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sequential therapy
Arm Type
Experimental
Arm Description
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
Arm Title
Quadruple therapy
Arm Type
Active Comparator
Arm Description
Esomeprazole 20mg bid, metronidazole 400mg aid, bismuth sub citrate 120mg aid and tetracycline 500mg qid, all for 10 days
Intervention Type
Drug
Intervention Name(s)
Sequential therapy
Other Intervention Name(s)
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
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Quadruple therapy
Other Intervention Name(s)
Esomeprazole (Nexium) 20mg bid, Metronidazole (Flagyl) 400mg qid, Bismuth subcitrate 120mg qid, Tetracycline 500mg qid, all for 10 days
Intervention Description
Esomeprazole 20mg bid, metronidazole 400mg qid, bismuth sub citrate 120mg qid and tetracycline 500mg qid, all for 10 days
Primary Outcome Measure Information:
Title
Helicobacter pylori eradication rate
Description
Percentage of patients successfully eradicated Helicobacter pylori infection confirmed by urea breath test
Time Frame
8 weeks after treatment
Secondary Outcome Measure Information:
Title
Development of side effects
Description
Patients to document side effects during treatment
Time Frame
10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ivan FN Hung, MD FRCP
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Hong Kong, Queen Mary Hospital
City
Hong Kong SAR
Country
Hong Kong
12. IPD Sharing Statement
Citations:
PubMed Identifier
24295850
Citation
Liu KS, Hung IF, Seto WK, Tong T, Hsu AS, Lam FY, But DY, Wong SY, Leung WK. Ten day sequential versus 10 day modified bismuth quadruple therapy as empirical firstline and secondline treatment for Helicobacter pylori in Chinese patients: an open label, randomised, crossover trial. Gut. 2014 Sep;63(9):1410-5. doi: 10.1136/gutjnl-2013-306120. Epub 2013 Dec 2.
Results Reference
derived
Learn more about this trial
Quadruple Versus Sequential Therapy for Helicobacter Pylori Eradication
We'll reach out to this number within 24 hrs