NCT02648659

Brief Summary

This study assessed the effect of tailored eradication therapy according to Clarithromycin resistance in Helicobacter pylori patients.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2016

Shorter than P25 for phase_4

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

First Submitted

Initial submission to the registry

January 5, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 7, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

March 2, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2017

Completed
Last Updated

August 9, 2018

Status Verified

August 1, 2018

Enrollment Period

10 months

First QC Date

January 5, 2016

Last Update Submit

August 7, 2018

Conditions

Peptic Ulcer

Outcome Measures

Primary Outcomes (1)

  • Eradication rate after tailored therapy assessed by urea breath test

    After completion of 14days tailored therapy, the participants will be followed at 4-6 weeks with urea breath test (UBT). The eradication rate will be assessed by the result of UBT.

    Test at 4 -6 weeks after completion of medication

Secondary Outcomes (1)

  • Number of participants with treatment-related adverse events as assessed by questionnaire

    Questionnaire and diary during medication for 14days

Study Arms (3)

triple with clarithromycin

EXPERIMENTAL

Ilaprazole 10mg qid, Amoxicillin 500mg qid, Clarithromycin bid for 2 weeks

Drug: IlaprazoleDrug: AmoxicillinDrug: Clarithromycin

triple with metronidazole

EXPERIMENTAL

Ilaprazole 10mg qid, Amoxicillin 500mg qid, Metronidazole 500mg tid for 2 weeks

Drug: IlaprazoleDrug: AmoxicillinDrug: Metronidazole

quadruple

EXPERIMENTAL

Ilaprazole 10mg qid, Amoxicillin 500mg qid, Clarithromycin 500mg bid, Metronidazole 500mg tid for 2 weeks

Drug: IlaprazoleDrug: AmoxicillinDrug: ClarithromycinDrug: Metronidazole

Interventions

IlaprazoleDRUG

Ilaprazole 10mg 1tablet qid(4 times/day)

Also known as: Noltec®
quadrupletriple with clarithromycintriple with metronidazole
AmoxicillinDRUG

Amoxicillin 500mg 1capsule qid(4times/day)

Also known as: Pamoxin®
quadrupletriple with clarithromycintriple with metronidazole
ClarithromycinDRUG

Clarithromycin 500mg 1tablet bid(2times/day)

Also known as: Clafaxin®
quadrupletriple with clarithromycin
MetronidazoleDRUG

Metronidazole 250mg 2tablets tid(3times/day)

Also known as: Flasinyl®
quadrupletriple with metronidazole

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 20 year old ≤ Male or female \< 80 year old
  • Among Patients with gastric or duodenal ulcer by endoscopy, Subject who is identified Helicobacter pylori-positive in the conduct of two or more of the following tests ; Rapid Urease test, Biopsy test, IgG-Hp antibody test.
  • Subject who fully understands conditions of clinical trial
  • Subject who agrees to participate and spontaneously sign the ICF

You may not qualify if:

  • Known hypersensitivity to experimental and concomitant drugs
  • Subjects who are taking contraindicated medications for experimental and concomitant drug.
  • Subjects with abnormal levels in the laboratory tests
  • Total Bilirubin, Creatinine\> 1.5 times upper limit of normal
  • AST, ALT, Alkaline phosphatase, BUN\> 2 times upper limit of normal
  • Administrated of PPI, antibiotic medication within 2 weeks prior to commencement of the study.
  • Pregnant and/or lactating women
  • Reproductive aged women not using contraception
  • Uncontrolled diabetics
  • Uncontrolled hypertension
  • Uncontrolled liver dysfunction
  • Alcoholics
  • Subjects with a history or possibility of digestive malignancy within 5 years
  • Subjects with a history of gastrectomy or esophagectomy
  • Subjects with hereditary diseases such as Galactose intolerance, Lapp lactose deficiency, glucose-galactose malabsorption
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Peptic Ulcer

Interventions

ilaprazoleAmoxicillinClarithromycinMetronidazole

Condition Hierarchy (Ancestors)

Duodenal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

AmpicillinPenicillin GPenicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsErythromycinMacrolidesPolyketidesLactonesNitroimidazolesNitro CompoundsImidazolesAzolesHeterocyclic Compounds, 1-Ring

Study Officials

  • Seong Woo Jeon

    Kyungpook national university medical center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Professor

Study Record Dates

First Submitted

January 5, 2016

First Posted

January 7, 2016

Study Start

March 2, 2016

Primary Completion

January 6, 2017

Study Completion

February 14, 2017

Last Updated

August 9, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share