UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009827 |
|---|---|
| Receipt number | R000011511 |
| Scientific Title | Botulinum toxin treatment for orofacial pain, bruxism or occlusal dysesthesia: (phase 2 patient study) Effect for the patients |
| Date of disclosure of the study information | 2013/04/01 |
| Last modified on | 2019/07/29 06:56:29 |
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Basic information
Public title
Botulinum toxin treatment for orofacial pain, bruxism or occlusal dysesthesia: (phase 2 patient study) Effect for the patients
Acronym
Botulinum toxin treatment for orofacial pain, bruxism or occlusal dysesthesia
Scientific Title
Botulinum toxin treatment for orofacial pain, bruxism or occlusal dysesthesia: (phase 2 patient study) Effect for the patients
Scientific Title:Acronym
Botulinum toxin treatment for orofacial pain, bruxism or occlusal dysesthesia
Region
| Japan |
Condition
Condition
orofacial pain, bruxism, occlusal dysethesia
Classification by specialty
| Neurology | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Measure of effect of BOTOX, A1 Botulinum toxin or A2 Botulinum toxin for orofacial pain, bruxism or occlusal dysethesia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
visual analogue scale data for subjective symptom
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Botulinum toxin 100U
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Out patients who will agree to enter this study. Over 20 years old. Male and female.
Key exclusion criteria
Subjects who have systematic problem
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yoshizo |
| Middle name | |
| Last name | Matsuka |
Organization
Tokushima University Hospital
Division name
Dentistry (Second prosthodontic)
Zip code
770-8504
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
088-633-7350
matsuka@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshizo |
| Middle name | |
| Last name | Matsuka |
Organization
Tokushima University Hospital
Division name
Dentistry (Second prosthodontic)
Zip code
770-8504
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
088-633-7350
Homepage URL
matsuka@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokushima University
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Trial Center for Developmental Therapeutics
Address
2-50-1 Kuramoto-cho, Tokushima
Tel
088-633-9294
awachiken@tokushima-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
徳島大学病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 04 | Month | 01 | 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
4
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 | 03 | Month | 31 | Day |
Date of IRB
| 2013 | Year | 02 | Month | 25 | Day |
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 01 | Month | 21 | Day |
Last modified on
| 2019 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011511
| Research Plan | |
|---|---|
| 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 |
