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

NCT ID: NCT02648659

Last Updated: 2018-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-02
• Study Completion Date: 2017-02-14

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

Conditions

Peptic Ulcer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

triple with clarithromycin

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

Group Type: EXPERIMENTAL

Ilaprazole

Intervention Type: DRUG

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

Amoxicillin

Intervention Type: DRUG

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

Clarithromycin

Intervention Type: DRUG

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

triple with metronidazole

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

Group Type: EXPERIMENTAL

Ilaprazole

Intervention Type: DRUG

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

Amoxicillin

Intervention Type: DRUG

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

Metronidazole

Intervention Type: DRUG

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

quadruple

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

Group Type: EXPERIMENTAL

Ilaprazole

Intervention Type: DRUG

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

Amoxicillin

Intervention Type: DRUG

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

Clarithromycin

Intervention Type: DRUG

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

Metronidazole

Intervention Type: DRUG

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

Interventions

Ilaprazole

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

Intervention Type: DRUG

Amoxicillin

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

Intervention Type: DRUG

Clarithromycin

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

Intervention Type: DRUG

Metronidazole

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

Intervention Type: DRUG

Other Intervention Names

Noltec®; Pamoxin®; Clafaxin®; Flasinyl®

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kyungpook National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Seong Woo Jeon

Associated Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Seong Woo Jeon

Role: PRINCIPAL_INVESTIGATOR

Kyungpook national university medical center

Other Identifiers

KNUMC-JSW-ILA01

Identifier Type: -

Identifier Source: org_study_id