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

Primary Purpose

Peptic Ulcer

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ilaprazole
Pantoprazole
Sponsored by
Il-Yang Pharm. Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peptic Ulcer

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Soonchunhang University Hospital
  • Inje Busan Paik Hospital
  • Pusan National University Hospital
  • Kyungpook National University Medical Center
  • Yeungnam University Medical Center
  • Konyang University Hospital
  • Gachon University Gill Medical Center
  • Wonkwang University of Medicine & Hospital
  • Chung Ang University Hospital
  • Ewha Womens University Mokdong Hospital
  • Inje University Seoul Paik Hospital
  • Kangbuk Samsung Hospital
  • KyungHee University Medical center
  • Seoul Asan hoapital
  • Seoul National University Hospital
  • Severance Hospital
  • The Catholic University of Korea, Seoul
  • Wonju Severance Christian Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ilaprazole or Pantoprazole placebo

Ilaprazole placebo or Pantoprazole

Arm Description

Ilaprazole 10mg, Pantoprazole 40mg, Amoxicillin 1000mg, Clarithromycin 500mg 2 times/day, PO

Pantoprazole 40mg, Ilaprazole 10mg, Amoxicillin 1000mg, Clarithromycin 500mg 2 times/day,PO

Outcomes

Primary Outcome Measures

the rate of H.pylori eradication

Secondary Outcome Measures

the rate of Gastric and/or Duodenal ulcer curation

Full Information

First Posted
March 5, 2014
Last Updated
June 2, 2014
Sponsor
Il-Yang Pharm. Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02084420
Brief Title
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

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Il-Yang Pharm. Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peptic Ulcer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
323 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ilaprazole or Pantoprazole placebo
Arm Type
Experimental
Arm Description
Ilaprazole 10mg, Pantoprazole 40mg, Amoxicillin 1000mg, Clarithromycin 500mg 2 times/day, PO
Arm Title
Ilaprazole placebo or Pantoprazole
Arm Type
Active Comparator
Arm Description
Pantoprazole 40mg, Ilaprazole 10mg, Amoxicillin 1000mg, Clarithromycin 500mg 2 times/day,PO
Intervention Type
Drug
Intervention Name(s)
Ilaprazole
Other Intervention Name(s)
NOLTEC
Intervention Description
10mg 2 BID( 2 times / day), before breakfast and dinner
Intervention Type
Drug
Intervention Name(s)
Pantoprazole
Other Intervention Name(s)
PANTOLOC
Intervention Description
40mg, BID(2 times / day), before breakfast and dinner
Primary Outcome Measure Information:
Title
the rate of H.pylori eradication
Time Frame
participants will be followed at 7 weeks (visit 4)
Secondary Outcome Measure Information:
Title
the rate of Gastric and/or Duodenal ulcer curation
Time Frame
participants will be followed at 7 weeks (visit 4)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
IL YANG PHARM
Organizational Affiliation
IL-YANG Pharmaceutical Co.LTD
Official's Role
Study Director
Facility Information:
Facility Name
Soonchunhang University Hospital
City
Bucheon-si, Gyeonggi-do
Country
Korea, Republic of
Facility Name
Inje Busan Paik Hospital
City
Busan
Country
Korea, Republic of
Facility Name
Pusan National University Hospital
City
Busan
Country
Korea, Republic of
Facility Name
Kyungpook National University Medical Center
City
Daegu
Country
Korea, Republic of
Facility Name
Yeungnam University Medical Center
City
Daegu
Country
Korea, Republic of
Facility Name
Konyang University Hospital
City
Daejeon
Country
Korea, Republic of
Facility Name
Gachon University Gill Medical Center
City
Incheon city
Country
Korea, Republic of
Facility Name
Wonkwang University of Medicine & Hospital
City
Jeollabuk-do
Country
Korea, Republic of
Facility Name
Chung Ang University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Ewha Womens University Mokdong Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Inje University Seoul Paik Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Kangbuk Samsung Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
KyungHee University Medical center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul Asan hoapital
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Severance Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Seoul
City
Seoul
Country
Korea, Republic of
Facility Name
Wonju Severance Christian Hospital
City
Wonju-si, Gangwon-do
Country
Korea, Republic of

12. IPD Sharing Statement

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

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