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

Kyungpook National University

Status and phase: Completed; Phase 4

Conditions: Peptic Ulcer

Treatments: Drug: Amoxicillin; Drug: Metronidazole; Drug: Ilaprazole; Drug: Clarithromycin

Study type: Interventional

Funder types: Other

Identifiers

NCT02648659

KNUMC-JSW-ILA01

Details and patient eligibility

About

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

Full 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

Enrollment: 50 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 3 patient groups

triple with clarithromycin

Experimental group

Description:

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

Treatment:

Drug: Clarithromycin

Drug: Ilaprazole

Drug: Amoxicillin

triple with metronidazole

Experimental group

Description:

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

Treatment:

Drug: Ilaprazole

Drug: Metronidazole

Drug: Amoxicillin

quadruple

Experimental group

Description:

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

Treatment:

Drug: Clarithromycin

Drug: Ilaprazole

Drug: Metronidazole

Drug: Amoxicillin