Clinical trial NCT02084420: Efficacy/Safety Study as H. Pylori Eradication of Triple Therapy for 7 Days Treatment
Official title: PhaseⅢ Study of A Multicenter, Randomized, Double-blind, Active-controlled to Evaluate of Efficacy /Safety as H. Pylori Eradication Effect Between Ilaprazole/Pantoprazole
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Peptic Ulcer
Lead sponsor: Il-Yang Pharm. Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-03-12
Enrollment: 323
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: the rate of H.pylori eradication
timeFrame: participants will be followed at 7 weeks (visit 4)
Secondary outcomes:
measure: the rate of Gastric and/or Duodenal ulcer curation
timeFrame: participants will be followed at 7 weeks (visit 4)
Other outcomes:
Locations:
city: Bucheon-si, Gyeonggi-do
country: Korea, Republic of
facility: Soonchunhang University Hospital
city: Busan
country: Korea, Republic of
facility: Inje Busan Paik Hospital
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Medical Center
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Daejeon
country: Korea, Republic of
facility: Konyang University Hospital
city: Incheon city
country: Korea, Republic of
facility: Gachon University Gill Medical Center
city: Jeollabuk-do
country: Korea, Republic of
facility: Wonkwang University of Medicine & Hospital
city: Seoul
country: Korea, Republic of
facility: Chung Ang University Hospital
city: Seoul
country: Korea, Republic of
facility: Ewha Womens University Mokdong Hospital
city: Seoul
country: Korea, Republic of
facility: Inje University Seoul Paik Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: KyungHee University Medical center
city: Seoul
country: Korea, Republic of
facility: Seoul Asan hoapital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul
city: Wonju-si, Gangwon-do
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
Study officials:
affiliation: IL-YANG Pharmaceutical Co.LTD
name: IL YANG PHARM
role: STUDY_DIRECTOR
References: