A Study on Eradication Rate of Triple Therapy According to Treatment Period and CYP2C19 Polymorphisms in H.Pylori Patients

A Study on Eradication Rate of Triple Therapy Including Low Dose-PPI, Clarithromycin, Amoxicillin According to Treatment Period and CYP2C19 Polymorphisms in H.Pylori Patients

This study compared efficacy and safety of basic triple therapy according to treatment period. This study evaluated Effect of CYP2C19 genetic polymorphisms on the efficacy

Study Overview

• Status: Unknown
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Procedure: treatment period

Detailed Description

This study compared efficacy and safety of basic triple therapy including Noltec(Ilaprazole) 10mg, Clapaxine(Clarithromycin) 500mg and Pamoxin Cap(Amoxicillin) 1000mg BID on the first line eradication treatment of H.pylori according to treatment period.

Participants are defined as persons who have endoscopically confirmed on gastric or duodenal ulcer(including scar stage) and gastritis confirmed to be H.pylori positive patients in the UBT test. For 7 days or 10 days Participants treated as basic triple therapy including Noltec(Ilaprazole) 10mg, Clapaxine(Clarithromycin) 500mg and Pamoxin Cap(Amoxicillin) 1000mg BID. After treatment, The healing rate was evaluated in the UBT test at 49±5days from the first day dosing. The investigators would point out the impact of CYP2C19 genotypes on Clarythromycin-based first-line and rescue therapies.

• Study Type: Observational
• Enrollment (Anticipated): 320

Contacts and Locations

• Study Contact: Name: Dongsoo Lee; Email: endoscope@hanmail.net

Study Locations

• Korea, Republic of
  • Daejeon, Korea, Republic of
    • Recruiting
    • The Catholic Univ. of Korea Daejeon St.Mary Hospital
    • Contact: Dongsoo Lee, MD, PhD
  • Daejeon, Korea, Republic of
    • Not yet recruiting
    • The Chunngnam Univ. General Hospital
    • Contact: JaeKyu Sung, MD, PhD
  • Daejeon, Korea, Republic of
    • Not yet recruiting
    • The Eulji Univ. General Hospital
    • Contact: Sunghee Jung, MD, PhD
  • Daejeon, Korea, Republic of
    • Not yet recruiting
    • The Konyang Univ. General Hospital
    • Contact: Sunmoon Kim, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who visited the hospital

Description

Inclusion Criteria:

• Subject must have endoscopically confirmed on gastric, duodenal ulcer(including scar) or gastritis confirmed to be H.pylori positive patients in the biopsy and UBT test.
• Subject who fully understands conditions of clinical trial.
• Subject who agrees to participate and spontaneously sign the ICF

Exclusion Criteria:

• Known hypersensitivity to any component of ilaprazole, Amoxicillin and Levofloxacin
• Subjects who are taking contraindicated medications for experimental and concomitant drug.
• Patients 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 4 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 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 wihin 30 days
• Inconsistence judged subject by researcher

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
7 days treament group; 7 days of triple therapy (Ilaprazole 10mg, Clarithromycin 500mg Amoxicillin 1000mg B.I.D)	Procedure: treatment period; 7 days treatment or 10 days treatment
10 days treatment group; 10 days of triple therapy (Ilaprazole 10mg, Clarithromycin 500mg Amoxicillin 1000mg B.I.D)	Procedure: treatment period; 7 days treatment or 10 days treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The eradication rate of H.pylori at Day 49±5(or Day 52±5) as assessed by UBT test or Biopsy	The eradication rate of H.pylori after 7 days(or 10 days) treatment is defined as those participants who have endoscopically confirmed on gastric or duodenal ulcer(including scar stage) and gastritis confirmed to be H.pylori positive patients in the biopsy or UBT test. The treatment : Noltec(Ilaprazole) 10mg+Pamoxine Cap(Amoxicillin) 1000mg+Clafaxine(Clarithromycin) 500mg was administered twice a day for 7days(or 10days)	Day 49±5(or Day 52±5)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The safety of Noltec(Ilaprazole) 10mg BID treatment at Day 49±5(or Day 52±5). Record the number of patients with adverse Events.	Record the number of patients with adverse Events. Also Record the symptoms, date, duration, and intensity of Adverse events such.	Day 49±5(or Day 52±5)
The eradication rate of H.pylori according to CYP polymorphism of patients.	The eradication rate of H.pylori is analyzed accroding to CYP polymorphism: CYP2C19 homo EM, hetero EM, PM	Day 49±5(or Day 52±5)
The eradication rate of H.pylori according to stage of disease of patients.	The eradication rate of H.pylori is analyzed accroding to stage of disease: active stage, healing stage, scar stage, gastritis.	Day 49±5(or Day 52±5)

Collaborators and Investigators

• Sponsor: Il-Yang Pharm. Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: March 28, 2017
• First Submitted That Met QC Criteria: April 3, 2017
• First Posted (Actual): April 4, 2017

Study Record Updates

• Last Update Posted (Actual): April 7, 2017
• Last Update Submitted That Met QC Criteria: April 6, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: CMC-LDS-ILA02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No