The Pilot Study on Tailored Eradication Therapy According to Clarithromycin Resistance in H.Pylori Patients

August 7, 2018 updated by: Seong Woo Jeon, Kyungpook National University Hospital

The Pilot Study on Tailored Eradication Therapy According to Clarithromycin Resistance in Helicobacter Pylori Patients

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

The patients with gastric or duodenal ulcer by endoscopy were registered at the study and inspected Rapid Urease test, Biopsy, IgG-Hp antibody.

The tailored eradication therapy was prescribed to patients that confirmed Helicobacter pylori positive in two or more of among the three tests for 14 days. Through this, This study is to assess the effectiveness of eradication rate and to evaluate safety and tolerability of Ilaprazole 10mg qid treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • • 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

Exclusion Criteria:

  • 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
  • Subjects participating in a clinical trial before another trial within 30 days
  • Inconsistence judged subject by researcher

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: triple with clarithromycin
Ilaprazole 10mg qid, Amoxicillin 500mg qid, Clarithromycin bid for 2 weeks
Drug: Ilaprazole
Ilaprazole 10mg 1tablet qid(4 times/day)
Other Names:
  • Noltec®
Drug: Amoxicillin
Amoxicillin 500mg 1capsule qid(4times/day)
Other Names:
  • Pamoxin®
Drug: Clarithromycin
Clarithromycin 500mg 1tablet bid(2times/day)
Other Names:
  • Clafaxin®
Experimental: triple with metronidazole
Ilaprazole 10mg qid, Amoxicillin 500mg qid, Metronidazole 500mg tid for 2 weeks
Drug: Ilaprazole
Ilaprazole 10mg 1tablet qid(4 times/day)
Other Names:
  • Noltec®
Drug: Amoxicillin
Amoxicillin 500mg 1capsule qid(4times/day)
Other Names:
  • Pamoxin®
Drug: Metronidazole
Metronidazole 250mg 2tablets tid(3times/day)
Other Names:
  • Flasinyl®
Experimental: quadruple
Ilaprazole 10mg qid, Amoxicillin 500mg qid, Clarithromycin 500mg bid, Metronidazole 500mg tid for 2 weeks
Drug: Ilaprazole
Ilaprazole 10mg 1tablet qid(4 times/day)
Other Names:
  • Noltec®
Drug: Amoxicillin
Amoxicillin 500mg 1capsule qid(4times/day)
Other Names:
  • Pamoxin®
Drug: Clarithromycin
Clarithromycin 500mg 1tablet bid(2times/day)
Other Names:
  • Clafaxin®
Drug: Metronidazole
Metronidazole 250mg 2tablets tid(3times/day)
Other Names:
  • Flasinyl®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eradication rate after tailored therapy assessed by urea breath test
Time Frame: Test at 4 -6 weeks after completion of medication
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with treatment-related adverse events as assessed by questionnaire
Time Frame: Questionnaire and diary during medication for 14days
During the medication of tailored therapy, the participants will be asked to check the compliance and adverse events with diary and questionnaire.
Questionnaire and diary during medication for 14days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyungpook National University Hospital

Investigators

  • Principal Investigator: Seong Woo Jeon, Kyungpook National University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2016

Primary Completion (Actual)

January 6, 2017

Study Completion (Actual)

February 14, 2017

Study Registration Dates

First Submitted

January 5, 2016

First Submitted That Met QC Criteria

January 6, 2016

First Posted (Estimate)

January 7, 2016

Study Record Updates

Last Update Posted (Actual)

August 9, 2018

Last Update Submitted That Met QC Criteria

August 7, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KNUMC-JSW-ILA01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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