UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014449 |
|---|---|
| Receipt number | R000012765 |
| Scientific Title | Evaluation of Treatment Response and Quality of Life of Esomeprazole for Reflux Esophagitis Patients |
| Date of disclosure of the study information | 2014/07/07 |
| Last modified on | 2022/07/07 12:38:38 |
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Basic information
Public title
Evaluation of Treatment Response and Quality of Life of Esomeprazole for
Reflux Esophagitis Patients
Acronym
Evaluation of Treatment Response and Quality of Life of Esomeprazole for
Reflux Esophagitis Patients
Scientific Title
Evaluation of Treatment Response and Quality of Life of Esomeprazole for
Reflux Esophagitis Patients
Scientific Title:Acronym
Evaluation of Treatment Response and Quality of Life of Esomeprazole for
Reflux Esophagitis Patients
Region
| Japan |
Condition
Condition
Reflux Esophagitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The aim of this study is to evaluate treatment response and quality of life of esomeprazole for
reflux esophagitis patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Response rate by GerdQ questionnaire 4, 8 weeks after administration of esomeprazole
Key secondary outcomes
Influence of CYP2C19 Polymorphism on esomaplazole responsiveness
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
esomeprazole 20mg/day for 8 weeks p.o.
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
The patient who is diagnosed as a reflux esophagitis and has been treated with PPI (expect for esomaprazole) for 4weeks, but GerdQ questionare shows insufficient therapeutic effect.
Key exclusion criteria
1,Patients with a history of hypersensitivity to the study drug.
2,Patients in the administration of atazanavir sulfate or a Rirupibirin hydrochloride.
3,Patients with confirmed gastric ulcer, duodenal ulcer by endoscopy.
4,Patients who have unstable merger liver, kidney, heart disease or serious medical conditions.
5,History of gastrointestinal tract resection or vagotomy.
6,Pregnancy and lactation.
7,Patients treated with esomeprazole 14 days before obtaining informed consent
8,Patient in need of administration of the following agents other than the study drug during the study period
(Excluding test drug), histamine H2-receptor antagonist, prokinetics, gastric mucosal protection, anticholinergic drugs, antacids, antidepressants, anti-anxiety drugs, steroids, bisphosphonates.
9,Patients who judged unsuitable for research participation.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Hidemi |
| Middle name | |
| Last name | Goto |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
466-8560
Address
65 Tsurumai-cho,Showa-ku, Nagoya
TEL
052-744-2172
hgoto@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Kohei |
| Middle name | |
| Last name | Funasaka |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
466-8560
Address
65 Tsurumai-cho,Showa-ku, Nagoya
TEL
052-744-2172
Homepage URL
k-funa@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine, Department of Gastroentelorogy and Hepatology
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University school of medicine
Address
65 Tsurumai-cho,Showa-ku, Nagoya
Tel
052-744-2423
ethics@med.nagoya-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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 07 | Month | 07 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
3
Results
Because of the difficulty for gathering a new registration, we unfortunately decided to discontinue this study.
Results date posted
| 2022 | Year | 07 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
None
Participant flow
None
Adverse events
None
Outcome measures
None
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2013 | Year | 09 | Month | 26 | Day |
Date of IRB
| 2013 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2013 | Year | 09 | Month | 27 | Day |
Last follow-up date
| 2017 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 07 | Month | 01 | Day |
Last modified on
| 2022 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012765
