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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2018-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Gastric Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ilaprazole

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

Group Type EXPERIMENTAL

Ilaprazole

Intervention Type DRUG

Ilaprazole 10mg 2tablets once a day(1 times / day), before breakfast

Rabeprazole

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

Group Type ACTIVE_COMPARATOR

Rabeprazole

Intervention Type DRUG

Rabeprazole 20mg 1tablets once a day(1 times / day), before breakfast

Interventions

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Ilaprazole

Ilaprazole 10mg 2tablets once a day(1 times / day), before breakfast

Intervention Type DRUG

Rabeprazole

Rabeprazole 20mg 1tablets once a day(1 times / day), before breakfast

Intervention Type DRUG

Other Intervention Names

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Ilaprazole(Noltec®) Pariet®

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No