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

Gastric Cancer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02638584
• Other study ID #: HUMC-ILA01
• Status: Completed
• Phase: Phase 4
• Start date: December 2015
• Est. completion date: March 2018

Study information

• Verified date: August 2018
• Source: Il-Yang Pharm. Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Gastrointestinal Hemorrhage
• Stomach Neoplasms

Intervention

Drug:
• Ilaprazole
Ilaprazole 10mg 2tablets once a day(1 times / day), before breakfast
• Rabeprazole
Rabeprazole 20mg 1tablets once a day(1 times / day), before breakfast

Locations

Country	Name	City	State
Korea, Republic of	HALLYM UNIVERSITY MEDICAL CENTER, Chuncheon Sacred Heart Hospital	Chuncheon	Gangwon-do

Sponsors (1)

Lead Sponsor	Collaborator
Il-Yang Pharm. Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Ulcer healing rate after endoscopic submucosal dissection		participants will be followed at 8 weeks
Secondary	The rate of Ulcer size reduction as assessed by measurements of ulcer size change.	The rate of Ulcer size reduction(?) : [(Initial ulcer size) - (Ulcer size at 8 weeks)] / (Initial ulcer size)	at 8 weeks after treatment
Secondary	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
Secondary	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