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Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034647
Receipt No. R000039501
Scientific Title Pain relief effect by local anesthetic at botulinum injection for essential blepharospasm
Date of disclosure of the study information 2018/10/26
Last modified on 2018/10/25

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Basic information
Public title Pain relief effect by local anesthetic at botulinum injection for essential blepharospasm
Acronym Pain relief effect by local anesthetic at botulinum injection
Scientific Title Pain relief effect by local anesthetic at botulinum injection for essential blepharospasm
Scientific Title:Acronym Pain relief effect by local anesthetic at botulinum injection
Region
Japan

Condition
Condition blepharospasm
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Blepharospasm (BS) is a disease in which eyelids opening becomes difficult, and in severe cases, effecti it is close to functional blindness. Although effectiveness of botulinum toxin type A (BTX - A) therapy is widely spread, injection site pain greatly affects patient satisfaction. Therefore, as the local anesthetics are also applied to insurance for adults, we evaluate the analgesic effect for injection site pain to compare the right eyelid with local anesthetics for 30 minutes and the left eyelid in BS patients who receive BTX-A for the first time at our hospital. Furthermore, in consecutive BS patients who received 5 or more times injections, we evaluate the analgesic effect in comparison with the past and this time with local anesthetics applied to both eyelids. Since a cure has yet to be found in BS, it is necessary to continue BTX-A treatment over a long period, and mental stress affect the medical condition, therefore, reduction of injection pain was an important issue. If analgesic effects of local anesthetics are demonstrated, patients who have extended the injection interval due to pain will be able to receive injections regularly, leading to amelioration of patient satisfaction for BTX treatment.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Visual analog scale(VAS) score
First injection group: comparison with righ eye and left eye
consecutive group: comparison with the past and this time
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
30 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria patinets with BTX therapy for the first time and consecutive patients with 5 or more times injection
Key exclusion criteria past history of lid surgery
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Osamu Mimura
Organization Hyogo college of medicine hospital
Division name Deoartment of Ophthalmology
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya city, Hyogo, Japan
TEL 0798-45-6462
Email mimu@hyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akiko Kimura
Organization Hyogo college of medicine hospital
Division name Deoartment of Ophthalmology
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya city, Hyogo, Japan
TEL 0798-45-6462
Homepage URL
Email akis@hyo-med.ac.jp

Sponsor
Institute Hyogo college of medicine hospital
Institute
Department

Funding Source
Organization Ministory 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
Address
Tel
Email

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
2018 Year 10 Month 26 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 No longer recruiting
Date of protocol fixation
2018 Year 06 Month 29 Day
Date of IRB
Anticipated trial start date
2018 Year 06 Month 29 Day
Last follow-up date
2018 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information There are 10 people in the first group and 70 in the cosecutive group, and we prepare to give a presentation at the annual meeting of the Japanese Ophthalmological Society in April 2019.

Management information
Registered date
2018 Year 10 Month 25 Day
Last modified on
2018 Year 10 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039501

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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