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

Phase 4

Completed

• Conditions: Peptic Ulcer
• Interventions: Drug: Ilaprazole; Drug: Amoxicillin; Drug: Metronidazole; Drug: Clarithromycin

• Registration Number: NCT02648659
• Lead Sponsor: Kyungpook National University Hospital

Brief Summary

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

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 Timeline

• Study First Submitted: 2016-01-05
• Study First Submitted QC: 2016-01-06
• Study First Posted: 2016-01-07
• Study Start: 2016-03-02
• Primary Completion: 2017-01-06
• Study Completion: 2017-02-14
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-07
• Last Update Posted: 2018-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
triple with clarithromycin	Amoxicillin	Ilaprazole 10mg qid, Amoxicillin 500mg qid, Clarithromycin bid for 2 weeks
triple with metronidazole	Metronidazole	Ilaprazole 10mg qid, Amoxicillin 500mg qid, Metronidazole 500mg tid for 2 weeks
quadruple	Amoxicillin	Ilaprazole 10mg qid, Amoxicillin 500mg qid, Clarithromycin 500mg bid, Metronidazole 500mg tid for 2 weeks
quadruple	Clarithromycin	Ilaprazole 10mg qid, Amoxicillin 500mg qid, Clarithromycin 500mg bid, Metronidazole 500mg tid for 2 weeks
triple with metronidazole	Ilaprazole	Ilaprazole 10mg qid, Amoxicillin 500mg qid, Metronidazole 500mg tid for 2 weeks
quadruple	Ilaprazole	Ilaprazole 10mg qid, Amoxicillin 500mg qid, Clarithromycin 500mg bid, Metronidazole 500mg tid for 2 weeks
triple with clarithromycin	Ilaprazole	Ilaprazole 10mg qid, Amoxicillin 500mg qid, Clarithromycin bid for 2 weeks
triple with clarithromycin	Clarithromycin	Ilaprazole 10mg qid, Amoxicillin 500mg qid, Clarithromycin bid for 2 weeks
triple with metronidazole	Amoxicillin	Ilaprazole 10mg qid, Amoxicillin 500mg qid, Metronidazole 500mg tid for 2 weeks
quadruple	Metronidazole	Ilaprazole 10mg qid, Amoxicillin 500mg qid, Clarithromycin 500mg bid, Metronidazole 500mg tid for 2 weeks

Primary Outcome Measures

Name	Time	Method
Eradication rate after tailored therapy assessed by urea breath test	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

Name	Time	Method
Number of participants with treatment-related adverse events as assessed by questionnaire	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.