Efficacy and Safety of Basic Triple Therapy Including Ilaprazole on the First Line Eradication Treatment of H.Pylori
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|ClinicalTrials.gov Identifier: NCT02352701|
Recruitment Status : Completed
First Posted : February 2, 2015
Last Update Posted : August 27, 2015
|Condition or disease||Intervention/treatment|
|Helicobacter Infections||Drug: Noltec tab. 10mg Drug: Chongkundang Amoxicillin Cap. 500mg Drug: Cravit Tab. 500mg|
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.
|Study Type :||Observational|
|Actual Enrollment :||320 participants|
|Observational Model:||Case Control|
|Official Title:||Efficacy and Safety of Basic Triple Therapy Including Ilaprazole, Levofloxacin on the First Line Eradication Treatment of H.Pylori|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||March 2014|
Noltec tab 10mg, Chongkundang Amoxicillin Cap 500mg 2caps and Cravit tab 500mg by oral, twice a day for 10 days
Drug: Noltec tab. 10mg
Ilaprazole 10mg BID dosage form : delayed release tablet
Other Name: Ilaprazole
Drug: Chongkundang Amoxicillin Cap. 500mg
Amoxicillin 1000mg, BID dosage form : capsule
Other Name: Amoxicillin
Drug: Cravit Tab. 500mg
Levofloxacin 500mg, BID dosage form : film coated tablet
Other Name: Levofloxacin
- 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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02352701
|Korea, Republic of|
|The Catholic Univ. of Korea Daejeon St.Mary Hospital|
|Daejeon, Korea, Republic of|
|Principal Investigator:||Dongsoo Lee, MD, PhD.||The Catholic Univ. of Korea, Daejeon St.Mary Hospital|