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Epidemiology of NonSteroidal Anti-Inflammatory Drugs (NSAIDs) associated small bowel injuries and Protective effect of mucosa protecting agents against NSAIDs associated small bowel injuries: A cohort study based upon Korean National Health Insurance Service claim database.

Status Approved

  • First Submitted Date

    2020/05/27

  • Registered Date

    2020/07/06

  • Last Updated Date

    2020/07/03

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number    		 KCT0005201
    Unique Protocol ID DUIH 2020-05-010
    Public/Brief Title Epidemiology of Non-Steroidal Anti-inflammatory Drug enteropathy : nationwide population study
    Scientific Title Epidemiology of NonSteroidal Anti-Inflammatory Drugs (NSAIDs) associated small bowel injuries and Protective effect of mucosa protecting agents against NSAIDs associated small bowel injuries: A cohort study based upon Korean National Health Insurance Service claim database.
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable

  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted exempt
    Board Approval Number DUIH 2020-05-010
    Approval Date 2020-05-25
    Institutional Review Board Name Dongguk University Ilsan Hospital IRB
    Institutional Review Board Address 27, Dongguk-ro, Ilsandong-gu, Goyang-si, Gyeonggi-do
    Institutional Review Board Telephone 031-961-8405
    Data Monitoring Committee No

  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name yun jeong LIM
    Title professor
    Telephone +82-31-961-7133
    Affiliation Dongguk University Ilsan Hospital
    Address 27 Donggukro ilsan- donggu
    Contact Person for Public Queries
    Name yun jeong LIM
    Title professor
    Telephone +82-31-961-5756
    Affiliation Dongguk University Ilsan Hospital
    Address 27 Donggukro ilsan- donggu
    Contact Person for Updating Information
    Name yun jeong LIM
    Title professor
    Telephone +82-31-961-5756
    Affiliation Dongguk University Ilsan Hospital
    Address 27 Donggukro ilsan- donggu

  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Multi-center Number of center : 2
    Overall Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-07-06 Anticipated
    Target Number of Participant 10000
    Primary Completion Date 2020-09-30 , Anticipated
    Study Completion Date 2020-12-31 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study Dongguk University Ilsan Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-07-06 ,
    Recruitment Status by Participating Study Site 2
    Name of Study Kyungpook National University Medical Center
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-07-06 ,

  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Dong-A ST
    Organization Type Pharmaceutical Company
    Project ID

  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Dongguk University Ilsan Hospital
    Organization Type Medical Institute

  • 7. Study Summary

    Study Summary Information
    Lay Summary 
    The aim is to identify the relation between Non-Steroidal Anti-inflammatory Drug-associated small bowel injury and mucosa-protecting agent.
The background is that there is little evidence on the effect of mucosa-protecting agent in the Non-Steroidal Anti-inflammatory Drug associated small bowel injury. 
The hypothesis is that mucosa-protecting agent can lower the risk of Non-Steroidal Anti-inflammatory Drug-associated small bowel injury.
The plan for this clinical study is that firstly, based on NHIS claim data, to find the patient who underwent small bowel capsule endoscopy, and to find out the patient who took Non-Steroidal Anti-inflammatory Drug and mucosa-protecting agent. Based on these, we will identify the relation between Non-Steroidal Anti-inflammatory Drug-associated small bowel injury and mucosa-protecting agent.

  • 8. Study Design

    Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
    Study Type Observational Study
    Observational Study Model Cohort
    Time Perspective Retrospective  
    Target Number of Participant 10000
    Cohort/Group Number 1
    Cohort/
    Group 1

    Cohort/Group Label

    patients with Non-Steroidal Anti-inflammatory Drug-associated small bowel injury

    Cohort/Group Description

    investigate patients with Non-Steroidal Anti-inflammatory Drug-associated small bowel injury  and patients who underwent small bowel capsule endoscopy
Collect the group of small intestine bleeding lesions observed in the small intestine capsule endoscopy and investigate the medication history. Match the age, sex, medication history, and past medical history of the collected observation group and set the control number 2-3 times. 
Based on data from national health insurance service, data was extracted using keywords. After close communication with the responsible research team (Gastroenterologist), an experienced big data research institute will extract data and perform statistical analysis
    Biospecimen
    Collection & Archiving    		 
    Not collect nor Archive
    Biospecimen Description 
    		
												
    
											    
										
    
									
									
								
							
    
						
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									9. Subject Eligibility
								
    
								
							
    
							
    
								
    
									Subject Eligibility Information
									
										
											
    
												Study Population Description
												
    In the NHIS claim data, pateints who underwent small bowel capsule endoscopy and took Non-Steroidal Anti-inflammatory Drug.
    		
											
    
											
    
												Sampling Method
												
    non-probability sampling :: To ask national health insurance service for the data on the pateints who underwent small bowel capsule endoscopy and took  Non-Steroidal Anti-inflammatory Drug,
collection of data regarding duration of usage of aspirin, Non-Steroidal Anti-inflammatory Drug, Aspirin and proton pump inhibitor.
    		
											
    
										
										
    
											Condition(s)/Problem(s)
											
												
												
												   (K00-K93)Diseases of the digestive system 
												
												
												

    
												Non-Steroidal Anti-inflammatory Drug-associated small bowel injury
												
											    		
										
    
										
    
											Rare Disease
											
												
													
													No
												
											
										
    
										
    
											
												Inclusion Criteria
											
											
												
    Gender
    
												Both
											    		
										
    
										
    
											
												
    Age
    
												No Limit~No Limit
											    		
										
    
										
    
											
												
    Description
    
												
    small bowel ulcer
small bowel bleeding
iron deficiency anemia
hematochezia
    
											    		
										
    
										
    
											
												Exclusion Criteria
											
											
												
    patient who did not take Non-Steroidal Anti-inflammatory Drug
patient who did not take mucosa-protecting agent
    
											    		
										
    
										
    
											
												Healthy Volunteers
											
											
												
													
													No
												
											
										
    
									    
								
    
							
    
						
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									10. Outcome Measure(s)
								
    
								
							
    
							
    
								
    
									Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
									
										
    
											
												
												Type of Primary Outcome
											
											Efficacy
										
    
										
											
    
												
													Primary Outcome(s) 1
												
											
    
											
    
												Outcome
												
    incidence rate of Non-Steroidal Anti-inflammatory Drug-associated small bowel injury in patient who took and did not take mucosa-protecting agent
    		
											
    
											
    
												Timepoint
												
    2020-11
    		
											
    
										
										
											
    
												
													Secondary Outcome(s) 1
												
											
    
											
    
												Outcome
												
    the kind of mucosa-protecting agents
    		
											
    
											
    
												Timepoint
												
    2020-11
    		
											
    
										
									    
								
    
							
    
						
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									11. Study Results and Publication
								
    
								
							
    
							
    
								
    
									Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
									
										
    
											Result Registered
											
												
													
													No
												
												
												
											
										
    
										
									    
								
    
							
    
						
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									12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
								
    
								
							
    
							
    
								
    
									Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
									
										
    
											Sharing Statement
											
												
													
													No
													
												
											
										
    
										
									    
								
    
							
    
						
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