UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014543 |
|---|---|
| Receipt number | R000016909 |
| Scientific Title | The investigation of the association of low-dose aspirin and reflux esophagitis |
| Date of disclosure of the study information | 2014/07/14 |
| Last modified on | 2017/07/17 09:30:56 |
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Basic information
Public title
The investigation of the association of low-dose aspirin and reflux esophagitis
Acronym
The investigation of the association of low-dose aspirin and reflux esophagitis
Scientific Title
The investigation of the association of low-dose aspirin and reflux esophagitis
Scientific Title:Acronym
The investigation of the association of low-dose aspirin and reflux esophagitis
Region
| Japan |
Condition
Condition
Reflux esophagitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate whether low-dose aspirin is related to reflux esophagitis and to evaluate treatment response of proton pump inhibitor for reflux esophagitis patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The risk odds ratio of the low-dose aspirin for the reflux esophagitis onset
Key secondary outcomes
The rate that reflux esophagitis improves by proton pump inhibitor administration
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
We let reflux esophagitis patients take esomeprazole 20mg/day for 8 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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients who diagnosed as reflux esophagitis, Los Angeles classification, grade A, B, C, or D, by esophagogastroduodenoscopy
Key exclusion criteria
1. Patients with active gastric ulcer or duodenal ulcer.
2. Patients with hypersensitivity to esomeprazole.
3. Patients in the administration of atazanavir sulfate or a Rirupibirin hydrochloride.
4. Patients with chronic alcoholism or drug dependence.
5. Patients with warning symptoms, such as vomitting, or sudden weight loss.
6. The patient who has difficulty in participation in this examination by the mergers such as a serious liver disease, renal disease, or heart trouble.
7. Pregnant women, nursing girls or the women who may be pregnant.
8. Patients who judged unsuitable for research participation.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Mizukami |
Organization
Oita university
Division name
Department of Gastroenterology
Zip code
Address
1-1, Idaigaoka, Hasama, Yufu, Oita
TEL
097-586-6193
mizkaz0809@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Mizukami |
Organization
Oita university
Division name
Department of Gastroenterology
Zip code
Address
1-1, Idaigaoka, Hasama, Yufu, Oita
TEL
097-586-6193
Homepage URL
mizkaz0809@oita-u.ac.jp
Sponsor or person
Institute
Oita university, department of Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
Non-profit Organization for Promotion of Gastrointestinal Disease Treatment Research
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
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
| 2014 | Year | 07 | Month | 14 | 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 | 09 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | 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
| 2014 | Year | 07 | Month | 13 | Day |
Last modified on
| 2017 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016909
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
