UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024818 |
|---|---|
| Receipt number | R000028566 |
| Scientific Title | The efficacy and safety of botulinum toxin type B on digital ulcers in patients with systemic sclerosis |
| Date of disclosure of the study information | 2016/11/14 |
| Last modified on | 2020/05/10 18:15:18 |
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Basic information
Public title
The efficacy and safety of botulinum toxin type B on digital ulcers in patients with systemic sclerosis
Acronym
The efficacy and safety of BTX-B on digital ulcers in patients with SSc
Scientific Title
The efficacy and safety of botulinum toxin type B on digital ulcers in patients with systemic sclerosis
Scientific Title:Acronym
The efficacy and safety of BTX-B on digital ulcers in patients with SSc
Region
| Japan |
Condition
Condition
digital ulcers in systemic sclerosis patients
Classification by specialty
| Clinical immunology | Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and safety of BTX-B on digital ulcers in Japanese patients with SSc.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of the patients which digital ulcer was healed by BTX-B at 8 weeks after treatment compared with that treated with placebo control.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
placebo subcutaneously injection into hands with digital ulcers
Interventions/Control_2
botulinum toxin type B subcutaneously injection into hands with digital ulcers
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
| 18 | 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.
SSc patients with digital ulcers
Key exclusion criteria
Patients under the age 18, 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 | Motegi |
| Middle name | |
| Last name | Sei-ichiro |
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
gunmaciru-office@umin.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
Gunma University
Address
Gunma
Tel
027-220-7111
gunmaciru-office@umin.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
群馬大学医学部附属病院（群馬県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 11 | 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
10
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 | 11 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 30 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 12 | Day |
Last follow-up date
| 2019 | Year | 05 | Month | 14 | Day |
Date of closure to data entry
| 2019 | Year | 05 | Month | 14 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 11 | Month | 14 | Day |
Last modified on
| 2020 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028566
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| Registered date | File name |
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