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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

Brief 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 Summary:

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.


Sponsor: Il-Yang Pharm. Co., Ltd.

Current Primary Outcome: The eradication rate of H.pylori at Day 49±5 as assessed by UBT test and Biopsy [ Time Frame: Day 49±5 ]

The eradication rate of H.pylori after 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 and UBT test.

The treatment : Noltec(Ilaprazole) 10mg+Chongkundang Amoxicillin(Amoxicillin) 1000mg+Cravit(Levofloxacin) 500mg was administered twice a day for 10days



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The safety of Noltec(Ilaprazole) 10mg BID treatment at Day 49±5. Record the number of patients with adverse Events [ Time Frame: Day 49±5 ]
    Record the number of patients with adverse Events. Also Record the symptoms, date, duration, and intensity of Adverse events such.
  • The healing rate of gastritis and ulcers at Day 49±5 as assessed by endoscopy confirmed to be active stage, healing stage and scarring stage. [ Time Frame: Day 49±5 ]
  • The rate of patients with Clarithromycin resistance as assessed by biopsy after treatment. [ Time Frame: Day 49±5 ]


Original Secondary Outcome: Same as current

Information By: Il-Yang Pharm. Co., Ltd.

Dates:
Date Received: January 26, 2015
Date Started: December 2012
Date Completion:
Last Updated: August 26, 2015
Last Verified: August 2015