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

Sponsor
Il-Yang Pharm. Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT02084420
Collaborator
(none)
323
Enrollment
18
Locations
2
Arms
13
Duration (Months)
17.9
Patients Per Site
1.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
323 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
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 Start Date :
Dec 1, 2012
Actual Primary Completion Date :
Jan 1, 2014
Actual Study Completion Date :
Jan 1, 2014

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. the rate of H.pylori eradication [participants will be followed at 7 weeks (visit 4)]

    Secondary Outcome Measures

    1. the rate of Gastric and/or Duodenal ulcer curation [participants will be followed at 7 weeks (visit 4)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 74 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Soonchunhang University Hospital Bucheon-si, Gyeonggi-do Korea, Republic of
    2 Inje Busan Paik Hospital Busan Korea, Republic of
    3 Pusan National University Hospital Busan Korea, Republic of
    4 Kyungpook National University Medical Center Daegu Korea, Republic of
    5 Yeungnam University Medical Center Daegu Korea, Republic of
    6 Konyang University Hospital Daejeon Korea, Republic of
    7 Gachon University Gill Medical Center Incheon city Korea, Republic of
    8 Wonkwang University of Medicine & Hospital Jeollabuk-do Korea, Republic of
    9 Chung Ang University Hospital Seoul Korea, Republic of
    10 Ewha Womens University Mokdong Hospital Seoul Korea, Republic of
    11 Inje University Seoul Paik Hospital Seoul Korea, Republic of
    12 Kangbuk Samsung Hospital Seoul Korea, Republic of
    13 KyungHee University Medical center Seoul Korea, Republic of
    14 Seoul Asan hoapital Seoul Korea, Republic of
    15 Seoul National University Hospital Seoul Korea, Republic of
    16 Severance Hospital Seoul Korea, Republic of
    17 The Catholic University of Korea, Seoul Seoul Korea, Republic of
    18 Wonju Severance Christian Hospital Wonju-si, Gangwon-do Korea, Republic of

    Sponsors and Collaborators

    • Il-Yang Pharm. Co., Ltd.

    Investigators

    • Study Director: IL YANG PHARM, IL-YANG Pharmaceutical Co.LTD

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Il-Yang Pharm. Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT02084420
    Other Study ID Numbers:
    • IY-81149-HB03
    First Posted:
    Mar 12, 2014
    Last Update Posted:
    Jun 3, 2014
    Last Verified:
    Jun 1, 2014
    Additional relevant MeSH terms:
    Peptic Ulcer
    Pantoprazole

    Study Results

    No Results Posted as of Jun 3, 2014