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Completed

NCT Number: NCT02648659

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

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

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Key information

Conditions

Peptic Ulcer Digestive System Diseases Duodenal Diseases Gastrointestinal Diseases Intestinal Diseases Stomach Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ilaprazole

Drug

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

Other names: Noltec®

Amoxicillin

Drug

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

Other names: Pamoxin®

Clarithromycin

Drug

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

Other names: Clafaxin®

Metronidazole

Drug

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

Other names: Flasinyl®

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Kyungpook National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 7, 2016
Registry last updated
Aug 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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