Back to resultsEradication Rate Between 1- and 2-Week Helicobacter Pylori Eradication Therapy
Primary Purpose
H.Pylori Gastrointestinal Disease
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Duration of HP therapy
Sponsored by
About this trial
This is an interventional treatment trial for H.Pylori Gastrointestinal Disease
Eligibility Criteria
Inclusion Criteria:
- Peptic ulcer including ulcer scar
- Early gastric cancer
- Gastric mucosa-associated lymphoid tissue lymphoma
Exclusion Criteria:
- operation history
- liver cirrhosis
- chronic kidney disease
- pregnancy
Sites / Locations
- The Catholic University of Korea
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
14 days
7 days
Arm Description
14 days treatment regimen
7 days treatment regimen
Outcomes
Primary Outcome Measures
the comparison with 7days and 14days eradication rate of PPI based therapy
Secondary Outcome Measures
the rate of side effects related to helicobacter eradication regimen
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02487511
Brief Title
Eradication Rate Between 1- and 2-Week Helicobacter Pylori Eradication Therapy
Official Title
Comparison of the Eradication Rate Between 1- and 2-Week PPI Containing Therapies for Helicobacter Pylori Eradication
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
August 1, 2015 (Actual)
Primary Completion Date
August 31, 2016 (Actual)
Study Completion Date
January 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St.Paul's Hospital, Korea
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
It is recommended as the first line treatment regimen to eradicate Helicobacter pylori (HP), 7 or 14 days treatment of proton pump inhibitor (PPI) based triple therapy consisting of one PPI and two antibiotics, clarithromycin and amoxicillin. In the case of treatment failure, 7 or 14 days of quadruple therapy (PPI＋metronidazole＋tetracycline＋bismuth) is recommended.
This study aims to investigate which duration would be better for eradication of HP. The study design is a randomized controlled trial. The patients were randomly assigned to 7 days or 14 days treatment groups. Primary endpoint was the eradication rate of PPI based triple therapy. Secondary endpoints were to compare the rate of drug compliance and side effects in both groups.
Detailed Description
The recommended duration of triple therapy is typically 10 to 14 days in the United States and 7 days in Europe. In Korea, it is recommended as the first line treatment regimen, 7 or 14 days treatment of proton pump inhibitor (PPI) based triple therapy consisting of one PPI and two antibiotics, clarithromycin and amoxicillin. In case for treatment failure which is often related to Helicobacter pylori (HP) resistance to clarithromycin or metronidazole, bismuth-based quadruple therapy is commonly used as second-line therapy, however, the eradication rates was widely ranged according to the treatment duration.
The objective of the study is to investigate whether treatment duration would affect the eradication rate of HP as a PPI based triple therapy (1st line therapy) and a bismuth-based quadruple therapy (2nd line therapy).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
H.Pylori Gastrointestinal Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
387 (Actual)
8. Arms, Groups, and Interventions
Arm Title
14 days
Arm Type
Active Comparator
Arm Description
14 days treatment regimen
Arm Title
7 days
Arm Type
No Intervention
Arm Description
7 days treatment regimen
Intervention Type
Other
Intervention Name(s)
Duration of HP therapy
Intervention Description
the comparison of HP eradication rate between 7 days and 14 days
Primary Outcome Measure Information:
Title
the comparison with 7days and 14days eradication rate of PPI based therapy
Time Frame
12 months after randomization
Secondary Outcome Measure Information:
Title
the rate of side effects related to helicobacter eradication regimen
Time Frame
12 months after randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Peptic ulcer including ulcer scar
Early gastric cancer
Gastric mucosa-associated lymphoid tissue lymphoma
Exclusion Criteria:
operation history
liver cirrhosis
chronic kidney disease
pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JUNG HWAN Oh, MD, PhD
Organizational Affiliation
the Catholic Univerisity of Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Catholic University of Korea
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32030921
Citation
Kim TH, Park JM, Cheung DY, Oh JH. Comparison of 7- and 14-Day Eradication Therapy for Helicobacter pylori with First- and Second-Line Regimen: Randomized Clinical Trial. J Korean Med Sci. 2020 Feb 10;35(5):e33. doi: 10.3346/jkms.2020.35.e33.
Results Reference
derived
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Eradication Rate Between 1- and 2-Week Helicobacter Pylori Eradication Therapy
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