UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000011775
Receipt No. 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 2013/09/15

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Institute Department of Gastroenterology, Okayama University Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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 Enrolling by invitation
Date of protocol fixation
2013 Year 07 Month 23 Day
Date of IRB
Anticipated trial start date
2013 Year 08 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 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
2013 Year 09 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013733


Contact us.