UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024135 |
|---|---|
| Receipt number | R000027791 |
| Scientific Title | Effect of botulinum toxin on Raynaud's phenomenon in patients with systemic sclerosis |
| Date of disclosure of the study information | 2016/09/23 |
| Last modified on | 2019/03/27 09:43:43 |
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Basic information
Public title
Effect of botulinum toxin on Raynaud's phenomenon in patients with systemic sclerosis
Acronym
BTX on Raynaud's phenomenon in SSc
Scientific Title
Effect of botulinum toxin on Raynaud's phenomenon in patients with systemic sclerosis
Scientific Title:Acronym
BTX on Raynaud's phenomenon in SSc
Region
| Japan |
Condition
Condition
Raynaud's phenomenon
Classification by specialty
| Clinical immunology | Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy of BTX on Raynaud's pehnomenon in Japanese patients with SSc.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Assessment
Primary outcomes
The change in severity of RP, including the frequency, pain, color and duration, by the Raynaud's condition score at 4 weeks after treatment compared with the baseline.
Key secondary outcomes
The change in severity of RP, including the frequency, pain, color and duration, by the Raynaud's condition score at 8, 12, 16 weeks after treatment compared with the baseline.
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
botulinum toxin injection
one time injection, subcutaneously injection
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All patients fulfilled the criteria of SSc proposed by the American College of Rheumatology and the American College of Rheumatology/European League Against Rheumatism classification criteria.
Key exclusion criteria
Patients under the age 16, with the pregnancy or having the past medical histories with BTX were excluded.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Sei-ichiro |
| Middle name | |
| Last name | Motegi |
Organization
Gunma University Graduate School of Medicine
Division name
Department of Dermatology
Zip code
371-8511
Address
3-39-22 Showa, Maebashi, Gunma 371-8511.
TEL
027-220-8284
smotegi@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Sei-ichiro |
| Middle name | |
| Last name | Motegi |
Organization
Gunma University Graduate School of Medicine
Division name
Department of Dermatology
Zip code
371-8511
Address
3-39-22 Showa, Maebashi, Gunma 371-8511.
TEL
027-220-8284
Homepage URL
smotegi@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japanese Ministry of Health, Labour
and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Gunma University
Address
3-39-15, Showa, Maebashi, Gunma, Japan
Tel
027-220-8740
smotegi@gunma-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
| 2016 | Year | 09 | Month | 23 | 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
2
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
| 2016 | Year | 05 | Month | 26 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 26 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 07 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 23 | Day |
Last modified on
| 2019 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027791
