Sequential and Hybrid Therapies for H Pylori Infection
Primary Purpose
Helicobacter Pylori Infection
Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
14-day sequential treatment
14-day hybrid treatment
Sponsored by
About this trial
This is an interventional treatment trial for Helicobacter Pylori Infection focused on measuring Helicobacter pylori infection
Eligibility Criteria
Inclusion Criteria:
- consecutive H. pylori-infected outpatients, at least 18 years of age, with endoscopically proven peptic ulcer diseases or gastritis
Exclusion Criteria:
- previous H. pylori-eradication therapy
- ingestion of antibiotics, bismuth, or PPIs within the prior 4 weeks
- patients with allergic history to the medications used
- patients with previous gastric surgery
- the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia)
- pregnant women.
Sites / Locations
- Kaohsiung Veterans General Hospital
- Kaohsiung Veterans General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
14-day sequential treatment
14-day hybrid treatment
Arm Description
One in which the first component consists of a proton pump inhibitor and amoxicillin given for 7 days followed by the PPI, clarithromycin and metronidazole for 7 days.
esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days
Outcomes
Primary Outcome Measures
Number of Participants in Which H. Pylori Was Eradicated
evaluate eradication outcome by endoscopy with urease test or urea breath test
Secondary Outcome Measures
Adverse Events
by standardized questionnaire
Compliance Rate
Good compliance is defined as taking equal or more than 90% of eradication medicines
Full Information
NCT ID
NCT01085786
First Posted
March 11, 2010
Last Updated
September 6, 2015
Sponsor
Kaohsiung Veterans General Hospital.
Collaborators
Baylor College of Medicine, Kaohsiung Medical University
1. Study Identification
Unique Protocol Identification Number
NCT01085786
Brief Title
Sequential and Hybrid Therapies for H Pylori Infection
Official Title
Comparison of 14-day Sequential and Hybrid Therapies for H Pylori Infection
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kaohsiung Veterans General Hospital.
Collaborators
Baylor College of Medicine, Kaohsiung Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Primary: To evaluate efficacy of 14 day 2-phase sequential therapy given in two forms. One in which the first component consists of a proton pump inhibitor and amoxicillin given for 7 days followed by the PPI, clarithromycin and metronidazole for 7 days. The alternate will be similar with the exception that the amoxicillin will be continued throughout the 14 days. The secondary endpoint is to evaluate the effectiveness of therapy in relation to antibiotic resistance.
Detailed Description
The purpose of this study is to test whether the 14-day sequential therapy ( esomeprazole plus amoxicillin dual therapy for 7 days followed by triple therapy with esomeprazole, clarithromycin, and metronidazole for 7 days) or 14-day hybird therapy (esomeprazole plus amoxicillin dual therapy for 7 days followed by quadruple therapy with esomeprazole, amoxicillin, clarithromycin, and metronidazole for 7 days) can achieve an eradication rate equal to or more than 95%.
A total of 240 subjects will be asked to participate in this study.
H. pylori-infected patients are randomized to either a 14-day sequential therapy (esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days) or a hybrid therapy (esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days).
Eradication efficacy is assessed by a follow-up endoscopy with rapid urease test and histological examination eight weeks after the end of anti-H. pylori therapy. The eradication rates of the two study groups will be compared.
A successful regimen is defined as a regimen achieving an eradication rate equal to or more than 95%.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Pylori Infection
Keywords
Helicobacter pylori infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
240 (Actual)
8. Arms, Groups, and Interventions
Arm Title
14-day sequential treatment
Arm Type
Active Comparator
Arm Description
One in which the first component consists of a proton pump inhibitor and amoxicillin given for 7 days followed by the PPI, clarithromycin and metronidazole for 7 days.
Arm Title
14-day hybrid treatment
Arm Type
Experimental
Arm Description
esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days
Intervention Type
Drug
Intervention Name(s)
14-day sequential treatment
Other Intervention Name(s)
Esomeprazole, amoxicillin, clarithromycin, metronidazole
Intervention Description
14-day sequential therapy arm: esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days
14-day hybrid therapy arm: esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days
Intervention Type
Drug
Intervention Name(s)
14-day hybrid treatment
Other Intervention Name(s)
esomeprazole + amoxicillin, then quadruple therapy
Intervention Description
esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days
Primary Outcome Measure Information:
Title
Number of Participants in Which H. Pylori Was Eradicated
Description
evaluate eradication outcome by endoscopy with urease test or urea breath test
Time Frame
Dec 2010
Secondary Outcome Measure Information:
Title
Adverse Events
Description
by standardized questionnaire
Time Frame
Dec 2010
Title
Compliance Rate
Description
Good compliance is defined as taking equal or more than 90% of eradication medicines
Time Frame
Dec 2010
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
consecutive H. pylori-infected outpatients, at least 18 years of age, with endoscopically proven peptic ulcer diseases or gastritis
Exclusion Criteria:
previous H. pylori-eradication therapy
ingestion of antibiotics, bismuth, or PPIs within the prior 4 weeks
patients with allergic history to the medications used
patients with previous gastric surgery
the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia)
pregnant women.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kwok-Hung Lai, PhD
Organizational Affiliation
Kaohsiung Veterans General Hospital.
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
David Y Graham, MD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
PING-I Hsu, MD, PhD
Organizational Affiliation
Kaohsiung Veterans General Hospital.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaohsiung Veterans General Hospital
City
Kaohsiung
ZIP/Postal Code
813
Country
Taiwan
Facility Name
Kaohsiung Veterans General Hospital
City
Kaohsiung
Country
Taiwan
12. IPD Sharing Statement
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Sequential and Hybrid Therapies for H Pylori Infection
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