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

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ClinicalTrials.gov Identifier: NCT02648659
Recruitment Status : Completed
First Posted : January 7, 2016
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
Seong Woo Jeon, Kyungpook National University

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

Condition or disease Intervention/treatment Phase
Peptic Ulcer Drug: Ilaprazole Drug: Amoxicillin Drug: Clarithromycin Drug: Metronidazole Phase 4

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: The Pilot Study on Tailored Eradication Therapy According to Clarithromycin Resistance in Helicobacter Pylori Patients
Actual Study Start Date : March 2, 2016
Actual Primary Completion Date : January 6, 2017
Actual Study Completion Date : February 14, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Peptic Ulcer

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 Name: Noltec®

Drug: Amoxicillin
Amoxicillin 500mg 1capsule qid(4times/day)
Other Name: Pamoxin®

Drug: Clarithromycin
Clarithromycin 500mg 1tablet bid(2times/day)
Other Name: 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 Name: Noltec®

Drug: Amoxicillin
Amoxicillin 500mg 1capsule qid(4times/day)
Other Name: Pamoxin®

Drug: Metronidazole
Metronidazole 250mg 2tablets tid(3times/day)
Other Name: 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 Name: Noltec®

Drug: Amoxicillin
Amoxicillin 500mg 1capsule qid(4times/day)
Other Name: Pamoxin®

Drug: Clarithromycin
Clarithromycin 500mg 1tablet bid(2times/day)
Other Name: Clafaxin®

Drug: Metronidazole
Metronidazole 250mg 2tablets tid(3times/day)
Other Name: Flasinyl®




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02648659


Sponsors and Collaborators
Kyungpook National University
Investigators
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Principal Investigator: Seong Woo Jeon Kyungpook national university medical center

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Responsible Party: Seong Woo Jeon, Associated Professor, Kyungpook National University
ClinicalTrials.gov Identifier: NCT02648659     History of Changes
Other Study ID Numbers: KNUMC-JSW-ILA01
First Posted: January 7, 2016    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Clarithromycin
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Amoxicillin
Metronidazole
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors