Peptic Ulcer
Conditions
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.
Interventions
DRUGIlaprazole
10mg 2 BID( 2 times / day), before breakfast and dinner
DRUGPantoprazole
40mg, BID(2 times / day), before breakfast and dinner
Sponsors
Il-Yang Pharm. Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the rate of H.pylori eradication | participants will be followed at 7 weeks (visit 4) |
Secondary
| Measure | Time frame |
|---|---|
| the rate of Gastric and/or Duodenal ulcer curation | participants will be followed at 7 weeks (visit 4) |
Countries
South Korea
Outcome results
None listed