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

Il-Yang Pharmaceutical

Status and phase

Completed

Phase 3

Conditions

Peptic Ulcer

Treatments

Drug: Pantoprazole

Drug: Ilaprazole

Study type

Interventional

Funder types

Industry

Identifiers

NCT02084420

IY-81149-HB03

Details and patient eligibility

About

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.

Full 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.

Enrollment

323 patients

Sex

All

Ages

18 to 74 years old

Volunteers

Accepts Healthy Volunteers

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