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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000007403
Receipt No. R000008725
Scientific Title The mucosal injury of small intestine in regular users of COX-2 selective inhibitor (Celecoxib) investigated by capsule endoscopy
Date of disclosure of the study information 2012/02/29
Last modified on 2014/08/29

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Basic information
Public title The mucosal injury of small intestine in regular users of COX-2 selective inhibitor (Celecoxib) investigated by capsule endoscopy
Acronym Capsule endoscopic findings in regular users of COX-2 selective inhibitor
Scientific Title The mucosal injury of small intestine in regular users of COX-2 selective inhibitor (Celecoxib) investigated by capsule endoscopy
Scientific Title:Acronym Capsule endoscopic findings in regular users of COX-2 selective inhibitor
Region
Japan

Condition
Condition Mucosal injury of small intestine due to COX-2 selective inhibitor
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate small intesinal mucosal injury due to regular use of COX-2 selective inhibitor by using capsule endoscopy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The prevalence of small intestinal lesions evaluated by capsule endoscopy
Key secondary outcomes Grade and number of the small intestinal lesions, The relationship between small intestinal lesions and patients' factors

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria Regular users of the COX-2 selective inhibitor who have already used it more than 4 weeks
Key exclusion criteria 1) Patients taking misoprostol

2) Patients taking other NSAIDs, steroid, anti-platelet agents except aspirin, anti-coagulants, or anti-cancer drugs

3) Patients with contraindication to capsule endoscopy

4) Patients with active bleeding lesions

5) Severely ill patients
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yamaji Yutaka
Organization The University of Tokyo Hospital
Division name Department of Gastroenterology
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-3815-5411
Email yamaji-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yutaka Yamaji
Organization The University of Tokyo Hospital
Division name Department of Gastroenterology
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-3815-5411
Homepage URL
Email yamaji-tky@umin.ac.jp

Sponsor
Institute Department of Gastroenterology, The University of Tokyo Hospital
Institute
Department

Funding Source
Organization Department of Gastroenterology, The University of Tokyo Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2012 Year 02 Month 29 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2011 Year 06 Month 23 Day
Date of IRB
Anticipated trial start date
2011 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Regular users of COX-2 selective inhibitor who have already used it more than 4 weeks are examined by capsule endoscopy. The lesions are classified as follows.
Category1:petechiae/red spot
Category2:reddened folds
Category3:denuded area
Category4:mucosal break/erosion/ulcer
Category5:stricture
Category6:presence of blood
Category7:other/angiodysplasia/polyp

Management information
Registered date
2012 Year 02 Month 29 Day
Last modified on
2014 Year 08 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008725

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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