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 : Completed
First Posted : December 23, 2015
Last Update Posted : July 31, 2020
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer||Drug: Ilaprazole Drug: Rabeprazole||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||176 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Primary Completion Date :||March 2018|
|Actual Study Completion Date :||March 2018|
Ilaprazole tab 10mg, 2 tablets once daily for 8 weeks.
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.
Rabeprazole 20mg 1tablets once a day(1 times / day), before breakfast
Other Name: Pariet®
- The Ulcer healing rate after endoscopic submucosal dissection [ Time Frame: participants will be followed at 8 weeks ]
- 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)
- 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.
- 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.
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
|Korea, Republic of|
|HALLYM UNIVERSITY MEDICAL CENTER, Chuncheon Sacred Heart Hospital|
|Chuncheon, Gangwon-do, Korea, Republic of|
|Principal Investigator:||ChangSeok Bang, MD, PhD||HALLYM UNIVERSITY MEDICAL CENTER, Chuncheon Sacred Heart Hospital|