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

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: Gastric Cancer
• Intervention / Treatment: Drug: Ilaprazole; Drug: Rabeprazole

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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.	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.	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.	The Korean Gastrointestinal Symptom Rating Scale questionnaire measured the patient's symptom degree.	at 8 weeks after treatment

Collaborators and Investigators

• 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

General Publications

• 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.

Study record dates

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: Endoscopic Submucosal Dissection; Ilaprazole; Gastric Adenoma; Early Gastric Cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Hemorrhage; Stomach Neoplasms; Gastrointestinal Hemorrhage; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Rabeprazole
• 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