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

PhaseⅢ Study of A Multicenter, Randomized, Double-blind, Active-controlled to Evaluate of Efficacy /Safety as H. Pylori Eradication Effect Between Ilaprazole/Pantoprazole

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.

Study Overview

• Status: Completed
• Conditions: Peptic Ulcer
• Intervention / Treatment: Drug: Ilaprazole; Drug: Pantoprazole

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.

• Study Type: Interventional
• Enrollment (Actual): 323
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ilaprazole or Pantoprazole placebo; Ilaprazole 10mg, Pantoprazole 40mg, Amoxicillin 1000mg, Clarithromycin 500mg 2 times/day, PO	Drug: Ilaprazole; 10mg 2 BID( 2 times / day), before breakfast and dinner; Other Names: NOLTEC
Active Comparator: Ilaprazole placebo or Pantoprazole; Pantoprazole 40mg, Ilaprazole 10mg, Amoxicillin 1000mg, Clarithromycin 500mg 2 times/day,PO	Drug: Pantoprazole; 40mg, BID(2 times / day), before breakfast and dinner; Other Names: PANTOLOC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the rate of H.pylori eradication	participants will be followed at 7 weeks (visit 4)

Secondary Outcome Measures

Outcome Measure	Time Frame
the rate of Gastric and/or Duodenal ulcer curation	participants will be followed at 7 weeks (visit 4)

Collaborators and Investigators

• Sponsor: Il-Yang Pharm. Co., Ltd.
• Investigators: Study Director: IL YANG PHARM, IL-YANG Pharmaceutical Co.LTD

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: March 5, 2014
• First Submitted That Met QC Criteria: March 7, 2014
• First Posted (Estimate): March 12, 2014

Study Record Updates

• Last Update Posted (Estimate): June 3, 2014
• Last Update Submitted That Met QC Criteria: June 2, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Intestinal Diseases; Duodenal Diseases; Peptic Ulcer; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Pantoprazole
• Other Study ID Numbers: IY-81149-HB03