Efficacy/Safety Study as H. Pylori Eradication of Triple Therapy for 7 Days Treatment
- Registration Number
- NCT02084420
- Lead Sponsor
- Il-Yang Pharm. Co., Ltd.
- Brief Summary
The purpose of this study is to evaluate of efficacy and safety as H.pylori eradiation effect between Ilaprazole and Pantoprazole triple therapy for 7 days treatment in Gastric and/or Duodenal ulcer patients with H.pylori positive infection.
- Detailed Description
This study is to evaluate of efficacy and safety as H.pylori eradiation effect between Ilaprazole and Pantoprazole triple therapy for 7 days treatment in Gastric and/or Duodenal ulcer patients with H.pylori positive infection.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 323
- 18 year old ≤ Male or female < 75 year old
- 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
- Patients with known allergy or hypersensitivity reaction to the Investigational products
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ilaprazole placebo or Pantoprazole Pantoprazole Pantoprazole 40mg, Ilaprazole 10mg, Amoxicillin 1000mg, Clarithromycin 500mg 2 times/day,PO Ilaprazole or Pantoprazole placebo Ilaprazole Ilaprazole 10mg, Pantoprazole 40mg, Amoxicillin 1000mg, Clarithromycin 500mg 2 times/day, PO
- Primary Outcome Measures
Name Time Method the rate of H.pylori eradication participants will be followed at 7 weeks (visit 4)
- Secondary Outcome Measures
Name Time Method the rate of Gastric and/or Duodenal ulcer curation participants will be followed at 7 weeks (visit 4)
Trial Locations
- Locations (18)
Kangbuk Samsung Hospital
🇰🇷Seoul, Korea, Republic of
Seoul Asan hoapital
🇰🇷Seoul, Korea, Republic of
Inje Busan Paik Hospital
🇰🇷Busan, Korea, Republic of
Wonkwang University of Medicine & Hospital
🇰🇷Jeollabuk-do, Korea, Republic of
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
Gachon University Gill Medical Center
🇰🇷Incheon city, Korea, Republic of
Yeungnam University Medical Center
🇰🇷Daegu, Korea, Republic of
Ewha Womens University Mokdong Hospital
🇰🇷Seoul, Korea, Republic of
Konyang University Hospital
🇰🇷Daejeon, Korea, Republic of
Inje University Seoul Paik Hospital
🇰🇷Seoul, Korea, Republic of
KyungHee University Medical center
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, Seoul
🇰🇷Seoul, Korea, Republic of
Wonju Severance Christian Hospital
🇰🇷Wonju-si, Gangwon-do, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Chung Ang University Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital
🇰🇷Seoul, Korea, Republic of
Kyungpook National University Medical Center
🇰🇷Daegu, Korea, Republic of
Soonchunhang University Hospital
🇰🇷Bucheon-si, Gyeonggi-do, Korea, Republic of