NCT02487511

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
387

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 1, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2017

Completed
Last Updated

June 9, 2017

Status Verified

June 1, 2017

Enrollment Period

1.1 years

First QC Date

June 25, 2015

Last Update Submit

June 7, 2017

Conditions

H.Pylori Gastrointestinal Disease

Outcome Measures

Primary Outcomes (1)

  • the comparison with 7days and 14days eradication rate of PPI based therapy

    12 months after randomization

Secondary Outcomes (1)

  • the rate of side effects related to helicobacter eradication regimen

    12 months after randomization

Study Arms (2)

14 days

ACTIVE COMPARATOR

14 days treatment regimen

Other: Duration of HP therapy

7 days

NO INTERVENTION

7 days treatment regimen

Interventions

Duration of HP therapyOTHER

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

14 days

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Peptic ulcer including ulcer scar
  • Early gastric cancer
  • Gastric mucosa-associated lymphoid tissue lymphoma

You may not qualify if:

  • operation history
  • liver cirrhosis
  • chronic kidney disease
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Catholic University of Korea

Seoul, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 32030921DERIVED

Study Officials

  • JUNG HWAN Oh, MD, PhD

    the Catholic Univerisity of Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 25, 2015

First Posted

July 1, 2015

Study Start

August 1, 2015

Primary Completion

August 31, 2016

Study Completion

January 31, 2017

Last Updated

June 9, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)