Efficacy/Safety Study as H. Pylori Eradication of Triple Therapy for 7 Days Treatment

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Il-Yang Pharm. Co., Ltd.
• Treatments: Pantoprazole

Criteria

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