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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

320 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-31

Study Completion Date

2014-03-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Helicobacter Infections

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Noltec®,ChongkundangAmoxicillin®,Cravit®

Noltec tab 10mg, Chongkundang Amoxicillin Cap 500mg 2caps and Cravit tab 500mg by oral, twice a day for 10 days

Noltec tab. 10mg

Intervention Type DRUG

Ilaprazole 10mg BID dosage form : delayed release tablet

Chongkundang Amoxicillin Cap. 500mg

Intervention Type DRUG

Amoxicillin 1000mg, BID dosage form : capsule

Cravit Tab. 500mg

Intervention Type DRUG

Levofloxacin 500mg, BID dosage form : film coated tablet

Interventions

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Noltec tab. 10mg

Ilaprazole 10mg BID dosage form : delayed release tablet

Intervention Type DRUG

Chongkundang Amoxicillin Cap. 500mg

Amoxicillin 1000mg, BID dosage form : capsule

Intervention Type DRUG

Cravit Tab. 500mg

Levofloxacin 500mg, BID dosage form : film coated tablet

Intervention Type DRUG

Other Intervention Names

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Ilaprazole Amoxicillin Levofloxacin

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No