Efficacy and Safety of Basic Triple Therapy Including Ilaprazole on the First Line Eradication Treatment of H.Pylori

Il-Yang Pharmaceutical

Status

Completed

Conditions

Helicobacter Infections

Treatments

Drug: Noltec tab. 10mg

Drug: Chongkundang Amoxicillin Cap. 500mg

Drug: Cravit Tab. 500mg

Study type

Observational

Funder types

Industry

Identifiers

NCT02352701

CMC-LDS-ILA01

Details and patient eligibility

About

This study compared efficacy and safety of basic triple therapy including Ilaprazole 10mg, Levofloxacin 500mg and Amoxicillin 1000mg BID for 10 days on the first line eradication treatment of H.pylori

Full description

This study compared efficacy and safety of basic triple therapy including Noltec(Ilaprazole) 10mg, Cravit(Levofloxacin) 500mg and Chongkundang Amoxicillin Cap(Amoxicillin) 1000mg BID on the first line eradication treatment of H.pylori.

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 biopsy and UBT test. For 10 days, Participants treated as basic triple therapy including Noltec(Ilaprazole) 10mg, Cravit(Levofloxacin) 500mg and Chongkundang Amoxicillin Cap(Amoxicillin) 1000mg BID. After treatment, The healing rate was evaluated in the UBT test and Biopsy at 49±5days from the first day dosing.

Enrollment

320 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