Efficacy/Safety Study as H. Pylori Eradication of Triple Therapy for 7 Days Treatment
NCT ID: NCT02084420
Last Updated: 2014-06-03
Study Results
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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COMPLETED
PHASE3
323 participants
INTERVENTIONAL
2012-12-31
2014-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ilaprazole or Pantoprazole placebo
Ilaprazole 10mg, Pantoprazole 40mg, Amoxicillin 1000mg, Clarithromycin 500mg 2 times/day, PO
Ilaprazole
10mg 2 BID( 2 times / day), before breakfast and dinner
Ilaprazole placebo or Pantoprazole
Pantoprazole 40mg, Ilaprazole 10mg, Amoxicillin 1000mg, Clarithromycin 500mg 2 times/day,PO
Pantoprazole
40mg, BID(2 times / day), before breakfast and dinner
Interventions
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Ilaprazole
10mg 2 BID( 2 times / day), before breakfast and dinner
Pantoprazole
40mg, BID(2 times / day), before breakfast and dinner
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients who had endoscopically confirmed Gastric and/or duodenal ulcer and H.pylori infection confirmed by Urea Breath Test
* Patients who understand the study conditions
* Patients who had been given the explanation about the study, and had provided voluntary written informed consent to participate in the stud
Exclusion Criteria
* Patients who use the Investigational products
* Patients who undergone H.pylori eradication
* Patients with abnormal laboratory results, as specified below:
Total bilirubin, creatinine \> 1.5 x upper limit of normal Aspartate transminase, Alanine transminase, Alkaline phosphatase, Blood urea nitrogen \> 2 x upper limit of normal
* Patients who used Proton Pump Inhibitor agents or antibiotics within the last 2 weeks before the start of the Investigational products
* Pregnant women and lactating women
* Women of childbearing potential who were not using a medically acceptable method of contraception during the study period.(Menopausal women who did not have a menstrual period for at least 12 months were considered infertile)
* Patients with uncontrolled Diabetes mellitus
* Patients with uncontrolled Hypertension
* Patients with Alcoholics
* Patients with a history of malignancy within 5 years prior to the study entry (Day 1) (except for basal cell carcinoma of the skin)
* Patients who had undergone a esophageal or gastric surgery
* Patients who had a hereditary disorder as galactose intolerance, lactose intolerance, glucose-galactose malabsorption
* Patients who had participated in other investigational study within 30 days before the study entry (Day 1)
* Patients who, in the investigator's opinion, are not suitable for the study for any other reason
18 Years
74 Years
ALL
Yes
Sponsors
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Il-Yang Pharm. Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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IL YANG PHARM
Role: STUDY_DIRECTOR
IL-YANG Pharmaceutical Co.LTD
Locations
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Soonchunhang University Hospital
Bucheon-si, Gyeonggi-do, , South Korea
Inje Busan Paik Hospital
Busan, , South Korea
Pusan National University Hospital
Busan, , South Korea
Kyungpook National University Medical Center
Daegu, , South Korea
Yeungnam University Medical Center
Daegu, , South Korea
Konyang University Hospital
Daejeon, , South Korea
Gachon University Gill Medical Center
Incheon, , South Korea
Wonkwang University of Medicine & Hospital
Jeollabuk-do, , South Korea
Chung Ang University Hospital
Seoul, , South Korea
Ewha Womens University Mokdong Hospital
Seoul, , South Korea
Inje University Seoul Paik Hospital
Seoul, , South Korea
Kangbuk Samsung Hospital
Seoul, , South Korea
KyungHee University Medical center
Seoul, , South Korea
Seoul Asan hoapital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
The Catholic University of Korea, Seoul
Seoul, , South Korea
Wonju Severance Christian Hospital
Wonju-si, Gangwon-do, , South Korea
Countries
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Other Identifiers
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IY-81149-HB03
Identifier Type: -
Identifier Source: org_study_id
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