NCT01922505

Brief Summary

The purpose of this study is to investigate the trend of eradication rates of first-line triple therapy for Helicobacter pylori in recent ten years and clinical factors that affect the eradication in Korean.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2003

Longer than P75 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
10.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 14, 2013

Completed
Last Updated

August 14, 2013

Status Verified

August 1, 2013

Enrollment Period

10.3 years

First QC Date

August 11, 2013

Last Update Submit

August 11, 2013

Conditions

Helicobacter Infections

Outcome Measures

Primary Outcomes (1)

  • Eradication Rates of First-line Triple Therapy for Helicobacter pylori

    Non invasive H. pylori test (13C-urea breath test(UBT)) or invasive H. pylori test (Giemsa histology, Rapid Urease test) were performed after four weeks after completing eradication therapy.

    Four weeks after completing eradication therapy

Secondary Outcomes (1)

  • Clinical Factors that Affect the Eradication

    Four weeks after completing eradication therapy

Study Arms (1)

PPI triple therapy

7-day PPI triple therapy regimen: PPI (esomeprazole 40 mg or omeprazole 20 mg or lansoprazole 30 mg or pantoprazole 40 mg or rabeprazole 20 mg) plus amoxicillin (1000mg) and clarithromycin (500mg) twice daily for 7 days.

Drug: PPI triple therapy

Interventions

PPI triple therapyDRUG
PPI triple therapy

Eligibility Criteria

Age16 Years - 92 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

H. pylori positive patient

You may qualify if:

  • Patients who proven H. pylori infection by invasive or non-invasive H. pylori test
  • Patients treated with First-line triple therapy (PPI + Amoxicillin + Clarithromycin)

You may not qualify if:

  • Previous eradication therapy for H. pylori
  • Follow-up loss patients after eradication therapy
  • Other treatment regimen
  • Poor medication compliance (\<80%)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Bundang-gu, Seongnam, Gyeonggi-do, 463-707, South Korea

Location

MeSH Terms

Conditions

Helicobacter Infections

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
4 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, M.D.

Study Record Dates

First Submitted

August 11, 2013

First Posted

August 14, 2013

Study Start

January 1, 2003

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

August 14, 2013

Record last verified: 2013-08

Locations

KR(1)