UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011775 |
|---|---|
| Receipt number | R000013733 |
| Scientific Title | A clinical study on the correlation between oxidative stress/antioxidant status and small intestinal mucosal injury in patients taking NSAIDs for long periods |
| Date of disclosure of the study information | 2013/09/17 |
| Last modified on | 2020/11/12 08:36:43 |
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Basic information
Public title
A clinical study on the correlation between oxidative stress/antioxidant status and small intestinal mucosal injury in patients taking NSAIDs for long periods
Acronym
A prospective multicenter observational study on the correlation between oxidative stress/antioxidant status and NSAIDs-induced small intestinal mucosal injury
Scientific Title
A clinical study on the correlation between oxidative stress/antioxidant status and small intestinal mucosal injury in patients taking NSAIDs for long periods
Scientific Title:Acronym
A prospective multicenter observational study on the correlation between oxidative stress/antioxidant status and NSAIDs-induced small intestinal mucosal injury
Region
| Japan |
Condition
Condition
Subjects who take NSAIDs(including low-dose aspirin) for more than 3 months and are suspected of occult OGIB
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to evaluate the incidence of NSAID-induced small intestinal mucosal injury, we will screen patients taking NSAIDs for long periods by using a capsule endoscopy. We will also ascertain the correlation between oxidative stress/antioxidant status and small intestinal mucosal injury in each case, and research the antioxidant treatment in the future.
Basic objectives2
Others
Basic objectives -Others
clinical verification
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The correlation between the number of oxidative stress marker/antioxidant status/regulatory T-cells in serum and the incidence of small intestinal mucosal injury
Key secondary outcomes
1) The incidence rate of NSAIDs-induced small intestinal mucosal injury in a capsule endoscopy
2) The correlation between the rate of PPI or H2-RA takers and the extent of small intestinal mucosal injury
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Subjects obtained written informed consent
2) Subjects taking NSAIDs(including commercial drugs and low-dose aspirin) for more than 3 months
3) Subjects who have iron deficient anemia the cause of which is unclear with esophagogastroduodenoscopy and colonoscopy, and are diagnosed Occult OGIB
Key exclusion criteria
1) Pregnant and nursing women
2) Subjects with contraindication of capsule endoscopy(gastrointestinal obstruction, stenosis, or fistula and a disorder of swallowing, etc)
3) Subjects who are judged inappropriate for the participation of the study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Okada |
Organization
Okayama University Hospital
Division name
Department of Endoscopy
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 700 8558, Japan
TEL
086-235-7219
hiro@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiyasu Kono |
Organization
Okayama University Hospital
Division name
Department of Gastroenterology
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 700 8558, Japan
TEL
086-235-7219
Homepage URL
hxnwq178@yahoo.co.jp
Sponsor or person
Institute
Department of Gastroenterology, Okayama University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Iwakuni Medical Center
Okayama Saiseikai General Hospital
Okayama Citizen's Hospital
Japanese Red Cross Okayama Hospital
Kagawa Prefectual Central Hospital
Kurashiki Central Hospital
Tsuyama Central Hospital
Japanese Red Cross Society Himeji Hospital
Fukuyama Medical Center
Fukuyama City Hospital
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
| 2013 | Year | 09 | Month | 17 | 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
Completed
Date of protocol fixation
| 2013 | Year | 07 | Month | 23 | Day |
Date of IRB
| 2013 | Year | 07 | Month | 23 | Day |
Anticipated trial start date
| 2013 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will asess the oxidative stress/antioxidant status by measuring d-ROM/OXY in the serum of the patients who are suspected of NSAIDs-induced small intestinal mucosal injury. After that we will perform a capsule endoscopy and score the extent of mucosal injury.
Management information
Registered date
| 2013 | Year | 09 | Month | 15 | Day |
Last modified on
| 2020 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013733
