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
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
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
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
