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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02084420
Other study ID # IY-81149-HB03
Secondary ID
Status Completed
Phase Phase 3
First received March 5, 2014
Last updated June 2, 2014
Start date December 2012
Est. completion date January 2014

Study information

Verified date June 2014
Source Il-Yang Pharm. Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority South Korea: Ministry of Food and Drug Safety
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Completed
Enrollment 323
Est. completion date January 2014
Est. primary completion date January 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 74 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Ilaprazole
10mg 2 BID( 2 times / day), before breakfast and dinner
Pantoprazole
40mg, BID(2 times / day), before breakfast and dinner

Locations

Country Name City State
Korea, Republic of Soonchunhang University Hospital Bucheon-si, Gyeonggi-do
Korea, Republic of Inje Busan Paik Hospital Busan
Korea, Republic of Pusan National University Hospital Busan
Korea, Republic of Kyungpook National University Medical Center Daegu
Korea, Republic of Yeungnam University Medical Center Daegu
Korea, Republic of Konyang University Hospital Daejeon
Korea, Republic of Gachon University Gill Medical Center Incheon city
Korea, Republic of Wonkwang University of Medicine & Hospital Jeollabuk-do
Korea, Republic of Chung Ang University Hospital Seoul
Korea, Republic of Ewha Womens University Mokdong Hospital Seoul
Korea, Republic of Inje University Seoul Paik Hospital Seoul
Korea, Republic of Kangbuk Samsung Hospital Seoul
Korea, Republic of KyungHee University Medical center Seoul
Korea, Republic of Seoul Asan hoapital Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Severance Hospital Seoul
Korea, Republic of The Catholic University of Korea, Seoul Seoul
Korea, Republic of Wonju Severance Christian Hospital Wonju-si, Gangwon-do

Sponsors (1)

Lead Sponsor Collaborator
Il-Yang Pharm. Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary the rate of H.pylori eradication participants will be followed at 7 weeks (visit 4) No
Secondary the rate of Gastric and/or Duodenal ulcer curation participants will be followed at 7 weeks (visit 4) No
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