UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009264
Receipt number R000010866
Scientific Title The evaluation of symptom and pathophysiological changes after 20mg of esomeprazole administration by 24-hour intraesophageal pH/impedance (MII-pH) monitoring.
Date of disclosure of the study information 2012/11/10
Last modified on 2019/11/11 09:13:24

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Basic information

Public title

The evaluation of symptom and pathophysiological changes after 20mg of esomeprazole administration by 24-hour intraesophageal pH/impedance (MII-pH) monitoring.

Acronym

The evaluation of symptom and pathophysiological changes after esomeprazole administration by impedance monitoring.

Scientific Title

The evaluation of symptom and pathophysiological changes after 20mg of esomeprazole administration by 24-hour intraesophageal pH/impedance (MII-pH) monitoring.

Scientific Title:Acronym

The evaluation of symptom and pathophysiological changes after esomeprazole administration by impedance monitoring.

Region

Japan


Condition

Condition

PPI-resistant gastro-esophageal reflux disease

Classification by specialty

Medicine in general Gastroenterology

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

To evaluate the symptom and pathophysiological changes by esomeprazole, PPI-resistant GERD patients are administrated esmeprazole instead of other PPIs and evaluate the symptom and pathophysiological changes.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

symptom, QOL, neurosis evaluation by questionnaire

Key secondary outcomes

pathophysiology of GERD by 24-hour intraesophageal pH/impedance monitoring, HP infection, gastric mucosal atropy, CYP2C19 genetic polymorphism


Base

Study type

Interventional


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

The subjects take 20 mg of esomeprazole once a day for four 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

(1) The study is conducted with the written informed consent of patients who had been given a full explanation of the study.
(2)The GERD patients who has taken standard dose PPIs for 8 weeks.
(3)The patients who was judged to be insufficient therapeutic response by GerdQ questionnaire.

Key exclusion criteria

(1)alarm sign such as vomitting or gastrointestinal bleeding
(2)Zollinger Ellison syndrome, esophageal stenosis, achalasia, cerebrovascular disorder
(3)Serious hepatic disorder, renal disease, heart disorder
(4)malignant disorder
(5)A pregnant woman, nursing mother or the woman who may be pregnant.
(6)In addition, clinical studies supervisor or the study attending physician judged the subject to be inadequate to attend this study.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Kunio
Middle name
Last name Kasugai

Organization

Aichi Medical University School of Medicine

Division name

Gastroenterology

Zip code

480-1195

Address

1-1 Yazakokarimata, Nagakute, Aichi, 480-1195, Japan

TEL

0561-62-3311

Email

kuku3487@aichi-med-u.ac.jp


Public contact

Name of contact person

1st name Kunio
Middle name
Last name Kasugai

Organization

Aichi Medical University School of Medicine

Division name

Gastroenterology

Zip code

480-1195

Address

1-1 Yazakokarimata, Nagakute, Aichi, 480-1195, Japan

TEL

0561-62-3311

Homepage URL


Email

kuku3487@aichi-med-u.ac.jp


Sponsor or person

Institute

Division of Gastroenterology, Aichi Medical University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Research Organization for GastroEnterological Disease Treatment

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

non

Name of secondary funder(s)

non


IRB Contact (For public release)

Organization

Aichi Medical University School of Medicine

Address

1-1 Yazakokarimata, Nagakute, Aichi, 480-1195, Japan

Tel

0561-62-3311

Email

syomu@aichi-med-u.ac.jp


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

愛知医科大学病院(愛知県)


Other administrative information

Date of disclosure of the study information

2012 Year 11 Month 10 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

2012 Year 05 Month 01 Day

Date of IRB

2012 Year 05 Month 30 Day

Anticipated trial start date

2012 Year 05 Month 30 Day

Last follow-up date

2016 Year 04 Month 30 Day

Date of closure to data entry

2016 Year 05 Month 31 Day

Date trial data considered complete

2016 Year 08 Month 31 Day

Date analysis concluded

2016 Year 10 Month 30 Day


Other

Other related information



Management information

Registered date

2012 Year 11 Month 05 Day

Last modified on

2019 Year 11 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010866


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name