NCT02352701

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 320 (actual)
• Sponsor: Il-Yang Pharm. Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Helicobacter Infections

Interventions

Type	Name	Description
DRUG	Noltec tab. 10mg	Ilaprazole 10mg BID dosage form : delayed release tablet
DRUG	Chongkundang Amoxicillin Cap. 500mg	Amoxicillin 1000mg, BID dosage form : capsule
DRUG	Cravit Tab. 500mg	Levofloxacin 500mg, BID dosage form : film coated tablet

Timeline

• Start date: 2012-12-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2015-02-02
• Last updated: 2015-08-27

Locations

1 site across 1 country: South Korea