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

Peptic Ulcer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02084420
• Other study ID #: IY-81149-HB03
• 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

• Peptic Ulcer

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