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Efficacy of 1 week and 2 weeks standard triple therapy for the eradication of clarithromycin-sensitive helicobacter pylori infection

Status Approved

First Submitted Date

2020/08/03
Registered Date

2020/08/11
Last Updated Date

2020/08/06

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0005309
Unique Protocol ID	2020-06-020-001
Public/Brief Title	Efficacy of 1 week and 2 weeks standard triple therapy for the eradication of clarithromycin-sensitive helicobacter pylori infection
Scientific Title	Efficacy of 1 week and 2 weeks standard triple therapy for the eradication of clarithromycin-sensitive helicobacter pylori infection
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	2020-06-020-001
Approval Date	2020-07-13
Institutional Review Board Name	Inje University Haeundae Paik Hospital Institutional Review Board
Institutional Review Board Address	875, Haeun-daero, Haeundae-gu, Busan, Republic of Korea
Institutional Review Board Telephone	051-797-2747
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Tae Oh Kim
Title	Professor
Telephone	+82-51-797-0201
Affiliation	Inje University Haeundae Paik Hospital
Address	875, Haeun-daero, Haeundae-gu, Busan, Republic of Korea
Contact Person for Public Queries
Name	Jin Lee
Title	Assistant professor
Telephone	+82-51-797-0221
Affiliation	Inje University Haeundae Paik Hospital
Address	875, Haeun-daero, Haeundae-gu, Busan, Republic of Korea
Contact Person for Updating Information
Name	Jin Lee
Title	Assistant professor
Telephone	+82-51-797-0221
Affiliation	Inje University Haeundae Paik Hospital
Address	875, Haeun-daero, Haeundae-gu, Busan, Republic of Korea

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Not yet recruiting
Date of First Enrollment	2020-08-06 Anticipated
Target Number of Participant	180
Primary Completion Date	2021-07-31 , Anticipated
Study Completion Date	2021-08-31 , Anticipated
Name of Study	Inje University Haeundae Paik Hospital
Recruitment Status	Not yet recruiting
Date of First Enrollment	2020-08-06 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Inje University Haeundae Paik Hospital
Organization Type	Medical Institute
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Inje University Haeundae Paik Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	The eradication rate of standard triple therapy on H. pylori is decling as increasing antibiotic resistance, especially clarithromycin resistance. Tbe presence of clarithromycin resistance is important in the selection of antibacterial agents. The guidelines for the diagnosis and treatment of helicobacter pylori infection in Korea recommend a bismuth-containing quadruple therapy as first-line regimen in patients with clarithromycin resistance, and a standard triple therapy in patients with claritrhomycin sensitivity. According to previous studies, the eradication rate of standard triple therapy was reported as 83~97% in patients with clarithromycin sensitivity. However, the duration of standard triple therapy has not been established in patients with clarithromyci sensitivity. The study aimes to analyze the eradication rate, compliance, and side effects of 7-day and 14-day standard triple therapy in patients with clarithromycin sensitivity.

Study Summary Information

Lay Summary

The eradication rate of standard triple therapy on H. pylori is decling as increasing antibiotic resistance, especially clarithromycin resistance. Tbe presence of clarithromycin resistance is important in the selection of antibacterial agents. The guidelines for the diagnosis and treatment of helicobacter pylori infection in Korea recommend a bismuth-containing quadruple therapy as first-line regimen in patients with clarithromycin resistance, and a standard triple therapy in patients with claritrhomycin sensitivity. According to previous studies, the eradication rate of standard triple therapy was reported as 83~97&#37; in patients with clarithromycin sensitivity.  However, the duration of standard triple therapy has not been established in patients with clarithromyci sensitivity. 
The study aimes to analyze the eradication rate, compliance, and side effects of 7-day and 14-day standard triple therapy in patients with clarithromycin sensitivity.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Treatment
Phase	Not applicable
Intervention Model	Parallel
Blinding/Masking	Open
Allocation	RCT
Intervention Type	Drug
Intervention Description	Patients are randomly allocated to receive a 7-days or 14-days standard triple therapy (rabeprazole 20mg, amoxicillin 1.0g, clarithromycin 500mg, each administered twice daily for 7 days or 14 days). The eradication will be confirmed by urea breath test at 4 weeks after the last medication.
Number of Arms	2
Arm 1	Arm Label 1 week group
	Target Number of Participant 90
	Arm Type Active comparator
	Arm Description The patients in 1 week group receive a 7-day standard regimen (rabeprazole 20mg, amoxicillin 1.0g, clarithromycin 500mg, each administered twice daily for 7 days).
Arm 2	Arm Label 2 weeks group
	Target Number of Participant 90
	Arm Type Experimental
	Arm Description The patients in 2 weeks group receive a 14-days standard regimen (rabeprazole 20mg, amoxicillin 1.0g, clarithromycin 500mg, each administered twice daily for 14 days).

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (A00-B99)Certain infectious and parasitic diseases (B98.0)Helicobacter pylori[H.pylori] as the cause of diseases classified to other chapters Peptic ulcer, gastric neoplasms, Gastric lymphoma originating from mucosa-associated lymphoid tissue (MALT), Chronic gastritis
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 19Year~79Year
	Description Adults older than 19 and younger than 80 are eligible. Patients with peptic ulcer disease, gastric neoplasms, gastric MALT lymphoma, chronic gastritis with Helicobacter pylori infection are included in the study.
Exclusion Criteria	Patients with previous Helicobacter pylori eradication therapy, patients with stomach or esophageal surgery, patients with pregnancy or lactation, patients with renal or hepatic dysfunction, patients with previous history of allergy or hypersensitivity reactions to drugs, patients with infectious mononucleosis, Patients with hematologic disorders, patients with nervous system disease are excluded.
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	/Safety/Efficacy
Outcome	erdiaction rate
Timepoint	4 weeks after completion of medication
Secondary Outcome(s) 1
Outcome	adverse events
Timepoint	4 weeks after completion of medication
Secondary Outcome(s) 2
Outcome	compliance
Timepoint	4 weeks after completion of medication

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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