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

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 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


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

Value
https://center6.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