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

Il-Yang Pharmaceutical

Status: Unknown

Conditions: Helicobacter Pylori Infection

Treatments: Procedure: treatment period

Study type: Observational

Funder types: Industry

Identifiers

NCT03099876

CMC-LDS-ILA02

Details and patient eligibility

About

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

Full 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.

Enrollment: 320 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

320 participants in 2 patient groups

7 days treament group

Description:

7 days of triple therapy (Ilaprazole 10mg, Clarithromycin 500mg Amoxicillin 1000mg B.I.D)

Treatment:

Procedure: treatment period

10 days treatment group

Description:

10 days of triple therapy (Ilaprazole 10mg, Clarithromycin 500mg Amoxicillin 1000mg B.I.D)

Treatment:

Procedure: treatment period