Skip to main content
OpenTrials
Completed

NCT Number: NCT02638584

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

19 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

HALLYM UNIVERSITY MEDICAL CENTER, Chuncheon Sacred Heart Hospital

Chuncheon, Gangwon-do, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ilaprazole

Drug

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

Other names: Ilaprazole(Noltec®)

rabeprazole

Drug

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

Other names: Pariet®

Primary outcomes

  1. The Ulcer healing rate after endoscopic submucosal dissection

    Time frame: participants will be followed at 8 weeks

Secondary outcomes

  1. The rate of Ulcer size reduction as assessed by measurements of ulcer size change.

    Time frame: at 8 weeks after treatment

    The rate of Ulcer size reduction(Δ) : [(Initial ulcer size) - (Ulcer size at 8 weeks)] / (Initial ulcer size)

  2. The quality of ulcer healing as evaluated by the observation of investigator at tracking endoscopy.

    Time frame: 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.

  3. The evaluation of symptom score as assessed by the Korean Gastrointestinal Symptom Rating Scale questionnaire.

    Time frame: at 8 weeks after treatment

    The Korean Gastrointestinal Symptom Rating Scale questionnaire measured the patient's symptom degree.

Sponsors and collaborators

Lead sponsor

Il-Yang Pharm. Co., Ltd.

Industry

Registry information

Official study 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.

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Dec 23, 2015
Registry last updated
Jul 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.