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

Sponsor

Il-Yang Pharm. Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT02638584

Collaborator

(none)

176

Enrollment

Location

Arms

Duration (Months)

6.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer	Drug: Ilaprazole Drug: Rabeprazole	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

176 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Dec 1, 2015

Actual Primary Completion Date :

Mar 1, 2018

Actual Study Completion Date :

Mar 1, 2018

Arms and Interventions

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®

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®

Outcome Measures

Primary Outcome Measures

The Ulcer healing rate after endoscopic submucosal dissection [participants will be followed at 8 weeks]

Secondary Outcome Measures

The rate of Ulcer size reduction as assessed by measurements of ulcer size change. [at 8 weeks after treatment]
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. [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.
The evaluation of symptom score as assessed by the Korean Gastrointestinal Symptom Rating Scale questionnaire. [at 8 weeks after treatment]
The Korean Gastrointestinal Symptom Rating Scale questionnaire measured the patient's symptom degree.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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