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

Primary Purpose

Gastric Cancer

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ilaprazole
Rabeprazole
Sponsored by
Il-Yang Pharm. Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Ilaprazole, Gastric Adenoma, Early Gastric Cancer, Endoscopic Submucosal Dissection

Eligibility Criteria

19 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • HALLYM UNIVERSITY MEDICAL CENTER, Chuncheon Sacred Heart Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ilaprazole

Rabeprazole

Arm Description

Ilaprazole tab 10mg, 2 tablets once daily for 8 weeks.

Rabeprazole tab 20mg, 1 tablet once daily for 8 weeks.

Outcomes

Primary Outcome Measures

The Ulcer healing rate after endoscopic submucosal dissection

Secondary Outcome Measures

The rate of Ulcer size reduction as assessed by measurements of ulcer size change.
The rate of Ulcer size reduction(Δ) : [(Initial ulcer size) - (Ulcer size at 8 weeks)] / (Initial ulcer size)
The quality of ulcer healing as evaluated by the observation of investigator at tracking endoscopy.
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.
The evaluation of symptom score as assessed by the Korean Gastrointestinal Symptom Rating Scale questionnaire.
The Korean Gastrointestinal Symptom Rating Scale questionnaire measured the patient's symptom degree.

Full Information

First Posted
December 14, 2015
Last Updated
July 29, 2020
Sponsor
Il-Yang Pharm. Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02638584
Brief Title
Effects of Ilaprazole on Ulcer Healing Rate and Prevention of Gastrointestinal Bleeding in the Patients Undergone ESD.
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2018 (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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
Ilaprazole, Gastric Adenoma, Early Gastric Cancer, Endoscopic Submucosal Dissection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
176 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ilaprazole
Arm Type
Experimental
Arm Description
Ilaprazole tab 10mg, 2 tablets once daily for 8 weeks.
Arm Title
Rabeprazole
Arm Type
Active Comparator
Arm Description
Rabeprazole tab 20mg, 1 tablet once daily for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Ilaprazole
Other Intervention Name(s)
Ilaprazole(Noltec®)
Intervention Description
Ilaprazole 10mg 2tablets once a day(1 times / day), before breakfast
Intervention Type
Drug
Intervention Name(s)
Rabeprazole
Other Intervention Name(s)
Pariet®
Intervention Description
Rabeprazole 20mg 1tablets once a day(1 times / day), before breakfast
Primary Outcome Measure Information:
Title
The Ulcer healing rate after endoscopic submucosal dissection
Time Frame
participants will be followed at 8 weeks
Secondary Outcome Measure Information:
Title
The rate of Ulcer size reduction as assessed by measurements of ulcer size change.
Description
The rate of Ulcer size reduction(Δ) : [(Initial ulcer size) - (Ulcer size at 8 weeks)] / (Initial ulcer size)
Time Frame
at 8 weeks after treatment
Title
The quality of ulcer healing as evaluated by the observation of investigator at tracking endoscopy.
Description
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.
Time Frame
at 8 weeks after treatment
Title
The evaluation of symptom score as assessed by the Korean Gastrointestinal Symptom Rating Scale questionnaire.
Description
The Korean Gastrointestinal Symptom Rating Scale questionnaire measured the patient's symptom degree.
Time Frame
at 8 weeks after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ChangSeok Bang, MD, PhD
Organizational Affiliation
HALLYM UNIVERSITY MEDICAL CENTER, Chuncheon Sacred Heart Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
HALLYM UNIVERSITY MEDICAL CENTER, Chuncheon Sacred Heart Hospital
City
Chuncheon
State/Province
Gangwon-do
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
not yet decided
Citations:
PubMed Identifier
30167954
Citation
Bang CS, Shin WG, Seo SI, Choi MH, Jang HJ, Park SW, Kae SH, Yang YJ, Shin SP, Baik GH, Kim HY. Effect of ilaprazole on the healing of endoscopic submucosal dissection-induced gastric ulcer: randomized-controlled, multicenter study. Surg Endosc. 2019 May;33(5):1376-1385. doi: 10.1007/s00464-018-6412-9. Epub 2018 Aug 30.
Results Reference
derived

Learn more about this trial

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

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