UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026859 |
|---|---|
| Receipt number | R000030742 |
| Scientific Title | Effectiveness of therapy with acotinamide hydrochloride and Trimebutine Maleateon gastro-oesophagial disease in systemic sclerosis |
| Date of disclosure of the study information | 2017/04/05 |
| Last modified on | 2017/04/04 21:08:42 |
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Basic information
Public title
Effectiveness of therapy with acotinamide hydrochloride and Trimebutine Maleateon gastro-oesophagial disease in systemic sclerosis
Acronym
Therapy with acotinamide hydrochloride and Trimebutine Maleateon gastro-oesophagial disease in SSC
Scientific Title
Effectiveness of therapy with acotinamide hydrochloride and Trimebutine Maleateon gastro-oesophagial disease in systemic sclerosis
Scientific Title:Acronym
Therapy with acotinamide hydrochloride and Trimebutine Maleateon gastro-oesophagial disease in SSC
Region
| Japan |
Condition
Condition
systemic sclerosis
Classification by specialty
| Gastroenterology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to compare of effectiveness of acotinamide hydrochloride and trimebutine maleateon for gastro-esophagial symptoms in systemic sclerosis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
tally a questionnaire survey; general assessment of the degree of improvement or deterioration of gastro-esophageal symptom at 4W and 8W
Key secondary outcomes
assessment of each question in a questionnaire.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
acotinamaide hydrpchloride
100 mg tablets, 3 times/day, 28 days
Interventions/Control_2
trimebutine maleateon
100 mg tablets, 3 times/day, 28 days
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 patients with systemic sclerosis (both lc-SSc and dc-SSc) who have symptoms esophgial dysfunction.
The patients satisfied the SSc criteria 2007 by the Specified Disease Treatment Research Program based on the Health Service Bureau of the Ministry of Health, Labour and Welfare.
Key exclusion criteria
1) the patients who have taken proton pomp inhibitor or vonoprazan within 2 months.
2) the patients who have sensitivity against acotinamide hydrochloride or trimebutine maleateon
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yohko Murakawa |
Organization
Shimane University
Division name
Faculty of Medicine, Third Department of Internal Medicine
Zip code
Address
89-1 Enya-cho, Izumo, Shimane
TEL
0853-20-2196
murakawa@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mayuko Moriyama |
Organization
Shimane University Hospital
Division name
Department of Rheumatology
Zip code
Address
89-1 Enya-cho, Izumo, Shimane
TEL
0853-20-2197
Homepage URL
mmayuko@med.shimane-u.ac.jp
Sponsor or person
Institute
Third Department of Internal Medicine (Department of Rheumatology) Shimane University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Third Department of Internal Medicine (Department of Rheumatology) Shimane University Faculty of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Japanese Cross Society Matsue JCS Hospital
Shimane Prefecture central Hospital
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
島根大学医学部附属病院（島根県）、島根県立中央病院（島根県）、松江赤十字病院（島根県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 05 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 03 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | Month | 10 | 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
| 2017 | Year | 04 | Month | 04 | Day |
Last modified on
| 2017 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030742
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
