UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031901 |
|---|---|
| Receipt number | R000036425 |
| Scientific Title | Efficacy of acotiamide for scleroderma patients with esophageal symptoms |
| Date of disclosure of the study information | 2018/03/26 |
| Last modified on | 2020/10/17 09:19:05 |
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Basic information
Public title
Efficacy of acotiamide for scleroderma patients with esophageal symptoms
Acronym
Efficacy of acotiamide for scleroderma patients with esophageal symptoms.
Scientific Title
Efficacy of acotiamide for scleroderma patients with esophageal symptoms
Scientific Title:Acronym
Efficacy of acotiamide for scleroderma patients with esophageal symptoms.
Region
| Japan |
Condition
Condition
systemic sclerosis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Improvement of modified F scale
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
improvement of modified F scale
Key secondary outcomes
improvement of Izumo scale
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
proton pump inhibitor
Interventions/Control_2
proton pump inhibitor and acotiamide
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
Patients who meet the ACR/EULAR criteria for systemic sclerosis (2013)
Patients who have esophageal symptoms (modified F scale of 8 or more)
Key exclusion criteria
Patients who have gastric ulcer and duodenal ulcer (excluding reflux esophagitis)
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoto Tamura |
Organization
Juntendo University School of Medicine
Division name
Department of Internal Medicine and Rheumatology
Zip code
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
81-3-5802-1067
tnaoto@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kurisu Tada |
Organization
Juntendo University School of Medicine
Division name
Department of Internal Medicine and Rheumatology
Zip code
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
81-3-5802-1067
Homepage URL
chris@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University 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
Juntendo Tokyo Koto Geriatric Medical Center
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
| 2018 | Year | 03 | Month | 26 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 22 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 26 | Day |
Last modified on
| 2020 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036425
