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

NCT ID: NCT02487511

Last Updated: 2017-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

387 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-01

Study Completion Date

2017-01-31

Brief Summary

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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

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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).

Conditions

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H.Pylori Gastrointestinal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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14 days

14 days treatment regimen

Group Type ACTIVE_COMPARATOR

Duration of HP therapy

Intervention Type OTHER

the comparison of HP eradication rate between 7 days and 14 days

7 days

7 days treatment regimen

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Duration of HP therapy

the comparison of HP eradication rate between 7 days and 14 days

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St.Paul's Hospital, Korea

OTHER

Sponsor Role lead

Responsible Party

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JUNG HWAN OH

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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JUNG HWAN Oh, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

the Catholic Univerisity of Korea

Locations

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The Catholic University of Korea

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 32030921 (View on PubMed)

Other Identifiers

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HPTX Duration

Identifier Type: -

Identifier Source: org_study_id

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