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

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ClinicalTrials.gov Identifier: NCT02638584
Recruitment Status : Unknown
Verified August 2016 by Il-Yang Pharm. Co., Ltd..
Recruitment status was:  Recruiting
First Posted : December 23, 2015
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):
Il-Yang Pharm. Co., Ltd.

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.


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Study Type : Interventional  (Clinical Trial)
Estimated 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 : December 2015
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2017


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 Name: 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 Name: Pariet®




Primary Outcome Measures :
  1. The Ulcer healing rate after endoscopic submucosal dissection [ Time Frame: participants will be followed at 8 weeks ]

Secondary Outcome Measures :
  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.



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Ages Eligible for Study:   19 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02638584


Contacts
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Contact: ChangSeok Bang, MD, PhD cloudslove@hallym.or.kr

Locations
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Korea, Republic of
HALLYM UNIVERSITY MEDICAL CENTER, Chuncheon Sacred Heart Hospital Recruiting
Chuncheon, Gangwon-do, Korea, Republic of
Contact: ChangSeok Bang, MD,PhD       cloudslove@hallym.or.kr   
Sponsors and Collaborators
Il-Yang Pharm. Co., Ltd.
Investigators
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Principal Investigator: ChangSeok Bang, MD, PhD HALLYM UNIVERSITY MEDICAL CENTER, Chuncheon Sacred Heart Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Il-Yang Pharm. Co., Ltd.
ClinicalTrials.gov Identifier: NCT02638584     History of Changes
Other Study ID Numbers: HUMC-ILA01
First Posted: December 23, 2015    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: not yet decided

Keywords provided by Il-Yang Pharm. Co., Ltd.:
Ilaprazole
Gastric Adenoma
Early Gastric Cancer
Endoscopic Submucosal Dissection

Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Hemorrhage
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Hemorrhage
Pathologic Processes
Rabeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action