Eradication Rate Between 1- and 2-Week Helicobacter Pylor... | NCT02487511

Studies
Eradication Rate Between 1- and 2-Week Helicobacter Pylori Eradication Therapy

NCT02487511

Sponsor

St.Paul's Hospital, Korea

Status

Completed

Last Update Posted

Jun 9, 2017Actual

Enrollment

387Actual

Phase

Phase 4

Conditions

H.Pylori Gastrointestinal Disease

Interventions

Duration of HP therapy

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2015Actual

Primary Completion Date

Aug 31, 2016Actual

Completion Date

Jan 31, 2017Actual

First Submitted Date

Jun 25, 2015

First Submission Date that Met QC Criteria

Jun 30, 2015

First Posted Date

Jul 1, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 7, 2017

Last Update Posted Date

Jun 9, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

JUNG HWAN OH, Associate Professor, St.Paul's Hospital, KoreaPrincipal Investigator

Lead Sponsor

St.Paul's Hospital, KoreaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

387Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
14 days	Active Comparator	14 days treatment regimen	Other: Duration of HP therapy
7 days	No Intervention	7 days treatment regimen

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Duration of HP therapy	Other	the comparison of HP eradication rate between 7 days and 14 days	14 days

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the comparison with 7days and 14days eradication rate of PPI based therapy		12 months after randomization

Secondary Outcomes

Measure	Description	Time Frame
the rate of side effects related to helicobacter eradication regimen		12 months after randomization

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
JUNG HWAN Oh, MD, PhD	the Catholic Univerisity of Korea	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Catholic University of Korea		Seoul			South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32030921	Derived	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.