UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007403 |
|---|---|
| Receipt number | 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 12:30:54 |
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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
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
yamaji-tky@umin.ac.jp
Sponsor or person
Institute
Department of Gastroenterology, The University of Tokyo Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008725
