Back to resultsEfficacies of Two Bismuth Quadruple Therapies in the Second-line Treatment of H Pylori Infection
Primary Purpose
Helicobacter Pylori Infection
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
10d TL quadruple therapy
10d AL quadruple therapy
Sponsored by
About this trial
This is an interventional treatment trial for Helicobacter Pylori Infection focused on measuring Helicobacter pylori, Eradication rate, Rescue treatment
Eligibility Criteria
Inclusion Criteria:
- Consecutive H pylori-infected outpatients, at least 20 years of age with failure of first-line eradication treatments (standard triple, non-bismuth quadruple and bismuth quadruple therapies)
Exclusion Criteria:
- previous allergic reactions to the study medications,
- history of gastrectomy,
- use of antibiotics within the previous 4 weeks,
- pregnant or lactating women,
- coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia, and malignancy).
Sites / Locations
- Kaohsiung Veterans General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
10d TL quadruple therapy
10d AL quadruple therapy
Arm Description
esomeprazole 40 mg b.i.d. plus tripotassium dicitrate bismuthate 300 mg, tetracycline 500 mg and metronidazole 250 mg q.i.d. for 10 days
esomeprazole 40 mg b.i.d. plus tripotassium dicitrate bismuthate 300 mg, amoxicillin 500 mg and metronidazole 250 mg q.i.d. for 10 days
Outcomes
Primary Outcome Measures
Number of Participants in Which H. Pylori Was Eradicated
To assess eradication efficacy,repeated endoscopy with rapid urease test, histological
Secondary Outcome Measures
Full Information
NCT ID
NCT03779087
First Posted
December 16, 2018
Last Updated
March 18, 2021
Sponsor
Ping-I (William) Hsu, M.D.
1. Study Identification
Unique Protocol Identification Number
NCT03779087
Brief Title
Efficacies of Two Bismuth Quadruple Therapies in the Second-line Treatment of H Pylori Infection
Official Title
Efficacies of Two Bismuth Quadruple Therapies in the Second-line Treatment of H Pylori Infection - a Multi-center Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 11, 2018 (Actual)
Primary Completion Date
October 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ping-I (William) Hsu, M.D.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
From the profiles of antibiotic susceptibility data following eradication therapy, tetracycline, amoxicillin and levofloxacin are all good candidates of antibiotics used in the rescue treatment.
Detailed Description
The H pylori-infected adult patients with failure of standard triple therapy and H pylori-infected adult patients with failure of non-bismuth quadruple therapy are randomly assigned to either TL quadruple therapy (esomeprazole-bismuth-tetracycline-levofloxacin regimen) or AL quadruple therapy (esomeprazole-bismuth-amoxicillin-levofloxacin regimen) for 10 days. Repeated endoscopy with rapid urease test, histological examination and culture or urea breath tests is performed at six weeks after the end of anti-H pylori therapy.
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, Eradication rate, Rescue treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
184 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
10d TL quadruple therapy
Arm Type
Experimental
Arm Description
esomeprazole 40 mg b.i.d. plus tripotassium dicitrate bismuthate 300 mg, tetracycline 500 mg and metronidazole 250 mg q.i.d. for 10 days
Arm Title
10d AL quadruple therapy
Arm Type
Active Comparator
Arm Description
esomeprazole 40 mg b.i.d. plus tripotassium dicitrate bismuthate 300 mg, amoxicillin 500 mg and metronidazole 250 mg q.i.d. for 10 days
Intervention Type
Drug
Intervention Name(s)
10d TL quadruple therapy
Other Intervention Name(s)
esomeprazole 40 mg, tripotassium dicitrate bismuthate 300mg, tetracycline 500 mg, levofloxacin 500 mg
Intervention Description
esomeprazole 40 mg bid., tripotassium dicitrate bismuthate 300mg qid, tetracycline 500 mg qid, levofloxacin 500 mg qd.
Intervention Type
Drug
Intervention Name(s)
10d AL quadruple therapy
Other Intervention Name(s)
esomeprazole 40 mg, tripotassium dicitrate bismuthate 300mg, amoxicillin 500 mg, levofloxacin 500 mg
Intervention Description
esomeprazole 40 mg bid., tripotassium dicitrate bismuthate 300mg qid, amoxicillin 500 mg qid, levofloxacin 500 mg qd.
Primary Outcome Measure Information:
Title
Number of Participants in Which H. Pylori Was Eradicated
Description
To assess eradication efficacy,repeated endoscopy with rapid urease test, histological
Time Frame
sixth week after the end of anti- H. pylori therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Consecutive H pylori-infected outpatients, at least 20 years of age with failure of first-line eradication treatments (standard triple, non-bismuth quadruple and bismuth quadruple therapies)
Exclusion Criteria:
previous allergic reactions to the study medications,
history of gastrectomy,
use of antibiotics within the previous 4 weeks,
pregnant or lactating women,
coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia, and malignancy).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ping-I Hsu, Bachelor
Phone
+886-7-342-2121
Ext
8233
Email
williamhsup@yahoo.com.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ping-I Hsu, Bachelor
Organizational Affiliation
Kaohsiung Veterans General Hospital.
Official's Role
Study Chair
Facility Information:
Facility Name
Kaohsiung Veterans General Hospital
City
Kaohsiung
ZIP/Postal Code
813
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ping I Hsu, MD
12. IPD Sharing Statement
Learn more about this trial
Efficacies of Two Bismuth Quadruple Therapies in the Second-line Treatment of H Pylori Infection
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