Clinical trial NCT02638584: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastric Cancer
Keywords: Ilaprazole
Gastric Adenoma
Early Gastric Cancer
Endoscopic Submucosal Dissection
Lead sponsor: Il-Yang Pharm. Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-12-23
Enrollment: 176
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The Ulcer healing rate after endoscopic submucosal dissection
timeFrame: participants will be followed at 8 weeks
Secondary outcomes:
measure: The rate of Ulcer size reduction as assessed by measurements of ulcer size change.
timeFrame: at 8 weeks after treatment
measure: The quality of ulcer healing as evaluated by the observation of investigator at tracking endoscopy.
timeFrame: at 8 weeks after treatment
measure: The evaluation of symptom score as assessed by the Korean Gastrointestinal Symptom Rating Scale questionnaire.
timeFrame: at 8 weeks after treatment
Other outcomes:
Locations:
city: Chuncheon
country: Korea, Republic of
facility: HALLYM UNIVERSITY MEDICAL CENTER, Chuncheon Sacred Heart Hospital
state: Gangwon-do
Study officials:
affiliation: HALLYM UNIVERSITY MEDICAL CENTER, Chuncheon Sacred Heart Hospital
name: ChangSeok Bang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.