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Ilaprazole for the Treatment of Gastroesophageal Reflux Disease (GERD) in Chinese Patients

Primary Purpose

Gastroesophageal Reflux Disease

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
10 mg ilaprazole
40mg esomeprazole
Sponsored by
Livzon Pharmaceutical Group Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux Disease focused on measuring GERD

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Consenting patients will be eligible for enrollment if they:
  • are 18-70 years of age,
  • have at least one of the two symptoms, heartburn and reflux,
  • have photographically documented erosive esophagitis confirmed by esophagogastroduodenoscopy(EGD), and graded according to the Los Angeles (LA) Classification (A-D), within 5 days before randomization to treatment. Female patients are required to be nonpregnant, nonlactating, postmenopausal, surgically sterilized, or using a medically acceptable form of birth control, as determined by the investigator. Women of child- bearing potential will receive a pregnancy test.

Exclusion Criteria:

  • Patients will be ineligible if they:
  • have cancerous or peptic ulcers, Zollinger-Ellison syndrome, varices of esophagus or fundus of stomach
  • have a known history of gastric acid suppression operation, esophageal operation or peptic operation other than simple closure of perforation,
  • have severe complications, severe other diseases of digestive tract such as Crohn's disease and ulcerative colitis, and severe other systemic diseases,
  • have taken proton pump inhibitors within the 5 days or for more than three consecutive days within the two weeks immediately preceding start of study drug,
  • participated in a clinical trial with an investigational drug or device within the past three months,
  • have hypersensitivity or idiosyncratic reaction to ilaprazole, esomeprazole or any other benzimidazole,
  • have alcoholic intemperance, drug addiction or any other improper habits.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    10 mg ilaprazole

    40 mg esomeprazole

    Arm Description

    Outcomes

    Primary Outcome Measures

    Changes in stage of the ulcer assessed by endoscopic(week 8) changes relative to baseline (week 0) levels.

    Secondary Outcome Measures

    Full Information

    First Posted
    July 26, 2016
    Last Updated
    August 8, 2016
    Sponsor
    Livzon Pharmaceutical Group Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02860624
    Brief Title
    Ilaprazole for the Treatment of Gastroesophageal Reflux Disease (GERD) in Chinese Patients
    Official Title
    Efficacy and Safety of Ilaprazole for GERD: A Randomized, Double-Blind, Esomeprazole-Controlled, Phase 3, Multicenter Trial in China
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2011 (undefined)
    Primary Completion Date
    April 2013 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Livzon Pharmaceutical Group Inc.

    4. Oversight

    5. Study Description

    Brief Summary
    This study is designed to evaluate the efficacy and tolerability of ilaprazole relative to that of esomeprazole in healing erosive esophagitis and resolving accompanying symptoms of GERD.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gastroesophageal Reflux Disease
    Keywords
    GERD

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    10 mg ilaprazole
    Arm Type
    Experimental
    Arm Title
    40 mg esomeprazole
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    10 mg ilaprazole
    Intervention Description
    Two 5-mg ilaprazole tablets (Livzon Pharm Group Inc., China) being taken orally each morning on an empty stomach for 8 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    40mg esomeprazole
    Intervention Description
    One 20-mg omeprazole capsule (AstraZeneca, Losec) being taken orally each morning on an empty stomach for 8 weeks
    Primary Outcome Measure Information:
    Title
    Changes in stage of the ulcer assessed by endoscopic(week 8) changes relative to baseline (week 0) levels.
    Time Frame
    week 8

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Consenting patients will be eligible for enrollment if they: are 18-70 years of age, have at least one of the two symptoms, heartburn and reflux, have photographically documented erosive esophagitis confirmed by esophagogastroduodenoscopy(EGD), and graded according to the Los Angeles (LA) Classification (A-D), within 5 days before randomization to treatment. Female patients are required to be nonpregnant, nonlactating, postmenopausal, surgically sterilized, or using a medically acceptable form of birth control, as determined by the investigator. Women of child- bearing potential will receive a pregnancy test. Exclusion Criteria: Patients will be ineligible if they: have cancerous or peptic ulcers, Zollinger-Ellison syndrome, varices of esophagus or fundus of stomach have a known history of gastric acid suppression operation, esophageal operation or peptic operation other than simple closure of perforation, have severe complications, severe other diseases of digestive tract such as Crohn's disease and ulcerative colitis, and severe other systemic diseases, have taken proton pump inhibitors within the 5 days or for more than three consecutive days within the two weeks immediately preceding start of study drug, participated in a clinical trial with an investigational drug or device within the past three months, have hypersensitivity or idiosyncratic reaction to ilaprazole, esomeprazole or any other benzimidazole, have alcoholic intemperance, drug addiction or any other improper habits.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    29540336
    Citation
    Xue Y, Qin X, Zhou L, Lin S, Wang L, Hu H, Xia J. A randomized, double blind, controlled, multi center study of Ilaparazole in the treatment of reflux esophagitis-Phase III clinical trial. Contemp Clin Trials. 2018 May;68:67-71. doi: 10.1016/j.cct.2018.03.004. Epub 2018 Mar 11.
    Results Reference
    derived

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    Ilaprazole for the Treatment of Gastroesophageal Reflux Disease (GERD) in Chinese Patients

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