NCT01938534

Brief Summary

Prospective study : Helicobacter pylori eradication therapy in accordance with past antibiotics use.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
440

participants targeted

Target at P75+ for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2013

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 5, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 10, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Last Updated

January 1, 2014

Status Verified

December 1, 2013

Enrollment Period

1.2 years

First QC Date

September 5, 2013

Last Update Submit

December 31, 2013

Conditions

Helicobacter Eradication

Outcome Measures

Primary Outcomes (1)

  • Eradication rate of Helicobacter pylori

    one month

Study Arms (2)

Experimental

EXPERIMENTAL

Omeprazole 30mg twice Clarithromycin 500mg twice Amoxicillin 1000mg twice for 10 days

Drug: Helicobacter pylori eradication

Control

ACTIVE COMPARATOR

Tetracycline 500mg four times Omeprazole 30mg twice Bismuth 600mg twice Metronidazole 500mg three times for 10 days

Drug: Helicobacter pylori eradication

Interventions

Helicobacter pylori eradicationDRUG
ControlExperimental

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Peptic ulcer disease
  • Gastric MALT lymphoma
  • Early gastric cancer
  • Familial history of gastric cancer
  • Idiopathic iron deficiency
  • Chronic idiopathic thrombocytopenia
  • Atrophic gastritis
  • Helicobacter infected dyspepsia
  • Long term NSAIDs use

You may not qualify if:

  • Pregnant
  • Previous proton pump inhibitor, antibiotics or anticoagulant use within 2 weeks
  • Previous stomach surgery
  • Severe ill patients (heart failure, hepatic failure, renal failure, hematologic disorder, severe psychologic or neurologic disorder)
  • Previous Helicobacter eradication
  • Allergy for Helicobacter eradication medicine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ajou University Hospital

Suwon, 443-721, South Korea

RECRUITING

Central Study Contacts

Ki Myung Lee, M.D., Ph.D.

CONTACT

82-31-219-6939lkm5104@ajou.ac.kr

Sun Gyo Lim, M.D.

CONTACT

82-31-219-6939mdlsk75@hanmail.net

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
Assistant professor

Study Record Dates

First Submitted

September 5, 2013

First Posted

September 10, 2013

Study Start

September 1, 2013

Primary Completion

December 1, 2014

Last Updated

January 1, 2014

Record last verified: 2013-12

Locations

KR(1)