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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000009264
Receipt No. 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 2018/05/10

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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
Middle name
Last name Kunio Kasugai
Organization Aichi Medical University School of Medicine
Division name Gastroenterology
Zip code
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
Middle name
Last name Kunio Kasugai
Organization Aichi Medical University School of Medicine
Division name Gastroenterology
Zip code
Address 1-1 Yazakokarimata, Nagakute, Aichi, 480-1195, Japan
TEL 0561-62-3311
Homepage URL
Email kuku3487@aichi-med-u.ac.jp

Sponsor
Institute Division of Gastroenterology, Aichi Medical University School of Medicine
Institute
Department

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
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 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 Open public recruiting
Date of protocol fixation
2012 Year 05 Month 01 Day
Date of IRB
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
2018 Year 05 Month 10 Day


Link to view the page
URL(English) https://upload.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


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