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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name