Effects of Ilaprazole on Ulcer Healing Rate and Prevention of Gastrointestinal Bleeding in the Patients Undergone ESD.

July 29, 2020 updated by: Il-Yang Pharm. Co., Ltd.

Effects of Ilaprazole 20mg on Ulcer Healing Rate and Prevention of Gastrointestinal Bleeding in the Patients Undergone Endoscopic Submucosal Dissection(ESD) for Gastric Adenoma or Early Gastric Cancer.

This study compared Ulcer healing rate of Ilaprazole 20mg or Rabeprazole 20mg in the patients undergone Endoscopic Submucosal Dissection for Gastric Adenoma or Early Gastric Cancer and investigated Prevention of gastrointestinal bleeding.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a Multicenter, Randomized, Parallel and Prospective study to compare Ulcer healing rate of Ilaprazole 20mg or Rabeprazole 20mg in the patients undergone Endoscopic Submucosal Dissection for Gastric Adenoma or Early Gastric Cancer and to investigate Prevention of gastrointestinal bleeding.

Participants are defined as persons who underwent a Endoscopic Submucosal Dissection for Gastric Adenoma or Early Gastric Cancer. For 8 weeks, Participants treated as Ilaprazole 20mg or Rabeprazole 20mg once a day. After treatment, The ulcer healing rate was evaluated by Endoscopy at 4, 8 weeks.

Study Type

Interventional

Enrollment (Actual)

176

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gangwon-do
      • Chuncheon, Gangwon-do, Korea, Republic of
        • HALLYM UNIVERSITY MEDICAL CENTER, Chuncheon Sacred Heart Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 19 year old ≤ Male or female < 85 year old
  • Subject who underwent Endoscopic Submucosal Dissection for Gastric Adenoma or Early Gastric Cancer
  • Subject who agrees to participate and spontaneously sign the Informed consent form(ICF).

Exclusion Criteria:

  • Known hypersensitivity to any component of ilaprazole
  • Subjects who are taking contraindicated medications(ex. atazanavir) for experimental and concomitant drug.

  • Subjects with abnormal levels in the laboratory tests

    • Total Bilirubin, Creatinine> 1.5 times upper limit of normal
    • Alanine transaminase(ALT), Aspartate transaminase(AST), Alkaline phosphatase, Blood urea nitrogen(BUN)> 2 times upper limit of normal
  • Subjects diagnosed with other cancer within 5 years other than stomach cancer.
  • Subjects with a history of Zollinger-Ellison syndrome, Barrett's esophagus, primary esophageal motility abnormality, esophageal strictures, pancreatitis, malabsorption, severe cardiovascular or pulmonary disease
  • Subjects with a history of major surgery that can affect gastric acid secretion.
  • Subjects should continue taking the following medicine during the study period : anticholinergics, promoting motility agents, prostaglandin analogs, sucralfate, aspirin, steroid, NSAIDs drug
  • Subjects with uncontrolled organ failure (liver dysfunction, renal dysfunction)
  • Pregnant and/or lactating women
  • Subjects participating in a clinical trial before another trial within 30 days
  • Inconsistency judged subject by researcher

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Ilaprazole
Ilaprazole tab 10mg, 2 tablets once daily for 8 weeks.
Drug: Ilaprazole
Ilaprazole 10mg 2tablets once a day(1 times / day), before breakfast
Other Names:
  • Ilaprazole(Noltec®)
ACTIVE_COMPARATOR: Rabeprazole
Rabeprazole tab 20mg, 1 tablet once daily for 8 weeks.
Drug: Rabeprazole
Rabeprazole 20mg 1tablets once a day(1 times / day), before breakfast
Other Names:
  • Pariet®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The Ulcer healing rate after endoscopic submucosal dissection
Time Frame: participants will be followed at 8 weeks
participants will be followed at 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rate of Ulcer size reduction as assessed by measurements of ulcer size change.
Time Frame: at 8 weeks after treatment
The rate of Ulcer size reduction(Δ) : [(Initial ulcer size) - (Ulcer size at 8 weeks)] / (Initial ulcer size)
at 8 weeks after treatment
The quality of ulcer healing as evaluated by the observation of investigator at tracking endoscopy.
Time Frame: at 8 weeks after treatment
Apply 0.15% Indigo carmine to scarring of the ulcer and Describe the pattern of the scar as flat, nodular or intermediate at tracking endoscopy.
at 8 weeks after treatment
The evaluation of symptom score as assessed by the Korean Gastrointestinal Symptom Rating Scale questionnaire.
Time Frame: at 8 weeks after treatment
The Korean Gastrointestinal Symptom Rating Scale questionnaire measured the patient's symptom degree.
at 8 weeks after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Il-Yang Pharm. Co., Ltd.

Investigators

  • Principal Investigator: ChangSeok Bang, MD, PhD, HALLYM UNIVERSITY MEDICAL CENTER, Chuncheon Sacred Heart Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (ACTUAL)

March 1, 2018

Study Completion (ACTUAL)

March 1, 2018

Study Registration Dates

First Submitted

December 14, 2015

First Submitted That Met QC Criteria

December 20, 2015

First Posted (ESTIMATE)

December 23, 2015

Study Record Updates

Last Update Posted (ACTUAL)

July 31, 2020

Last Update Submitted That Met QC Criteria

July 29, 2020

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUMC-ILA01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

not yet decided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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