UMIN-CTR Clinical Trial

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
Email	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
Email	matsuka@tokushima-u.ac.jp

Sponsor
Institute	Tokushima University Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011511