UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011641
Receipt number R000013607
Scientific Title Magnification and ultra-magnification endoscopic evaluation of esphageal mucosa epithelia, inflammatory cells and micro vessels in patients with reflux esophagitis bofore and after esomeprazole prescription
Date of disclosure of the study information 2013/09/05
Last modified on 2015/01/11 22:27:18

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Basic information

Public title

Magnification and ultra-magnification endoscopic evaluation of esphageal mucosa epithelia, inflammatory cells and micro vessels in patients with reflux esophagitis bofore and after esomeprazole prescription

Acronym

reflux esophagitis, PPI treatment and magnification and ultra-magnification endoscopy

Scientific Title

Magnification and ultra-magnification endoscopic evaluation of esphageal mucosa epithelia, inflammatory cells and micro vessels in patients with reflux esophagitis bofore and after esomeprazole prescription

Scientific Title:Acronym

reflux esophagitis, PPI treatment and magnification and ultra-magnification endoscopy

Region

Japan


Condition

Condition

reflux esophagitis

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

to evaluate magnification and ultra-magnification endoscopic findings before and after administration of esomeprazole with special reference to inflammatory cell infiltration

Basic objectives2

Others

Basic objectives -Others

to evaluate the relationship between histopathological and immunohistochemical appearances and magnification and ultramagnification endoscopic findings

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

magnification and ultra-magnification endoscopic findings in reflux esophagitis before and after esomeprazole treatment

Key secondary outcomes

alteration in magnification and ultra-magnification endoscopic findings before and after esomeprazole treatment


Base

Study type


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

oral administration of 20mg of esomeprazole for 8 weeks

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

over 20 years old
PS(ECOG) 0 or 1
more than WBC, 3,000/mm3; Hb, 8.0g/d; Plt, 75,000/mm3; AST, 100IU/L; ALT, 100IU/L; T-bil, 2.0mg/dL; sCr, 2.0mg/dL
written informed consent

Key exclusion criteria

without cormobid severe diseases including heart, kidney and liver failure
during pregnancy and/or milk feeding

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hajime isomoto

Organization

Nagasaki University Hospital

Division name

Endoscopy

Zip code


Address

1-7-1 Sakamoto, Nagasaki

TEL

095-819-7336

Email

hhisomot@nagasaki-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hajime isomoto

Organization

Nagasaki University Hospital

Division name

Endoscopy

Zip code


Address

1-7-1 Sakamoto, Nagasaki

TEL

095-819-7336

Homepage URL


Email

hhisomot@nagasaki-u.ac.jp


Sponsor or person

Institute

Nagasaki University Hospital

Institute

Department

Personal name



Funding Source

Organization

Astra Zeneka

Organization

Division

Category of Funding Organization

Profit organization

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

2013 Year 09 Month 05 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

Open public recruiting

Date of protocol fixation

2013 Year 07 Month 22 Day

Date of IRB


Anticipated trial start date

2013 Year 09 Month 05 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 09 Month 03 Day

Last modified on

2015 Year 01 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013607


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name