UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010808 |
|---|---|
| Receipt number | R000012650 |
| Scientific Title | Study of the patient satisfaction in the self-reporting-questionnaire after the switching PPI from existing PPI to Esomeprazole in the reflux esophagitis patients |
| Date of disclosure of the study information | 2013/05/27 |
| Last modified on | 2017/06/22 10:54:15 |
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Basic information
Public title
Study of the patient satisfaction in the self-reporting-questionnaire after the switching PPI from existing PPI to Esomeprazole in the reflux esophagitis patients
Acronym
Study of the patient satisfaction in a self-reporting-questionnaire after the Esomeprazole switching
Scientific Title
Study of the patient satisfaction in the self-reporting-questionnaire after the switching PPI from existing PPI to Esomeprazole in the reflux esophagitis patients
Scientific Title:Acronym
Study of the patient satisfaction in a self-reporting-questionnaire after the Esomeprazole switching
Region
| Japan |
Condition
Condition
GERD
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Some reflux esophagitis patients remain with GERD symptom in spite of PPI treatment, and there are many patients who are not fully satisfied. Therefore, we switch PPI from other PPI to Esomeprazole for the RE patients who have GERD symptoms despite being administered other PPI, and we evaluate the change of the symptoms, the satisfaction level of patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assessment of patient satisfaction in a self-reporting-questionnaire
Key secondary outcomes
Comparison of the effect according to the background factor
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
Esomeplazole 20mg
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
Patient who fills everything the following
1) Man or woman who is 20 years old or older at the time of getting informed consent
2) Patient whom is given existing PPI, but one of the heartburn or acid reflux symptoms remains in
3) Patient that a document informed consent by the free intention of patients was gotten on enough understanding after having received enough explanation on participating in this study
Key exclusion criteria
The patient in conflict with the following exclusion criteria is not enrolled
1) Patient with the drug allergy
2) Patient who complicated a serious heart disease, serious liver disease, renal function disorder, and malignant tumor
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiko Inamori |
Organization
Yokohama City University Graduate School of Medicine
Division name
Gastroenterology Division
Zip code
Address
3-9 Fukuura, Kanagawa-ku, Yokohama, Japan
TEL
045-787-2800
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiko Inamori |
Organization
Yokohama City University Graduate School of Medicine
Division name
Gastroenterology Division
Zip code
Address
3-9 Fukuura, Kanagawa-ku, Yokohama, Japan
TEL
045-787-2800
Homepage URL
Sponsor or person
Institute
Yokohama City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
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 | 05 | Month | 27 | 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
| 2013 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 27 | 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 | 05 | Month | 27 | Day |
Last modified on
| 2017 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012650
