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Tailored Therapy for Clarithromycin-Resistant H. Pylori

Primary Purpose

Helicobacter Pylori Infection

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
PAM
PBMT
Sponsored by
Kangdong Sacred Heart Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Helicobacter Pylori Infection

Eligibility Criteria

19 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • peptic ulcer disease
  • H. pylori gastritis
  • low grade MALT lymphoma

Exclusion Criteria:

  • history of gastric cancer surgery
  • severe comorbidity (ESRD, LC)
  • hypersensitivity to drug
  • pregnancy

Sites / Locations

  • Kangdong Sacred Heart HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

PAM

PBMT

Arm Description

treatment with PPI, metonidazole, amoxicillin

treatment with PPI, metonidazole, bismuth, tetracyclin

Outcomes

Primary Outcome Measures

H. pylori eradication rate
H. pylori eradication rate

Secondary Outcome Measures

Full Information

First Posted
January 31, 2018
Last Updated
March 5, 2019
Sponsor
Kangdong Sacred Heart Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03431688
Brief Title
Tailored Therapy for Clarithromycin-Resistant H. Pylori
Official Title
Efficacy Comparison of Metronidazole-based Triple and Bismuth-based Quadruple Therapy for Clarithromycin Resistant-Helicobacter Pylori Infection: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
December 30, 2020 (Anticipated)
Study Completion Date
December 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kangdong Sacred Heart Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Clarithromycin-resistant H. pylori is the main cause of H. pylori eradication failure. Tailored therapy on the basis of detection of a clarithromycin resistance mutation by PCR has been studied recently, however, there have been few studies comparing treatment regimen in patient with clarithromycin-resistant H. pylori. We used sequencing-based clarithromycin resistance mutation and aimed to compare PAM (proton pump inhibitor, amoxicilline, metronidazole) regimen and PBMT (proton pump inhibitor, bismuth, metronidazole, tetracyclin) regimen in patient with clarithromycin-resistant H. pylori.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Pylori Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
660 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PAM
Arm Type
Active Comparator
Arm Description
treatment with PPI, metonidazole, amoxicillin
Arm Title
PBMT
Arm Type
Active Comparator
Arm Description
treatment with PPI, metonidazole, bismuth, tetracyclin
Intervention Type
Drug
Intervention Name(s)
PAM
Intervention Description
treatment with PPI, metonidazole, amoxicillin
Intervention Type
Drug
Intervention Name(s)
PBMT
Intervention Description
treatment with PPI, metonidazole, bismuth, tetracyclin
Primary Outcome Measure Information:
Title
H. pylori eradication rate
Description
H. pylori eradication rate
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: peptic ulcer disease H. pylori gastritis low grade MALT lymphoma Exclusion Criteria: history of gastric cancer surgery severe comorbidity (ESRD, LC) hypersensitivity to drug pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Woon Geon Shin
Phone
82-2-2225-2814
Email
sgun9139@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Woon Geon Shin
Organizational Affiliation
Kangdong Sacred Heart Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kangdong Sacred Heart Hospital
City
Seoul
ZIP/Postal Code
134-701
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Woon Geon Shin, MD
Phone
82-2-2225-2814
Email
sgun9139@gmail.com
First Name & Middle Initial & Last Name & Degree
Woon Geon Shin, MD

12. IPD Sharing Statement

Learn more about this trial

Tailored Therapy for Clarithromycin-Resistant H. Pylori

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