UMIN-CTR Clinical Trial

Basic information
Public title	Effect of using of local anesthesia for injection pain due to long-acting injectable antipsychotics
Acronym	Effect of using of local anesthesia for injection pain due to long-acting injectable antipsychotics
Scientific Title	Effect of using of local anesthesia for injection pain due to long-acting injectable antipsychotics
Scientific Title:Acronym	Effect of using of local anesthesia for injection pain due to long-acting injectable antipsychotics
Region	Japan

Condition
Condition	F20-29 Schizophrenia, schizophrenia-type disorder and delusional disorder
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Investigate whether it is possible to reduce pain by using a local anesthetic (topical) when using a long-acting injection.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	VAS
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Application of local anesthetic
Interventions/Control_2	Placebo application
Interventions/Control_3	do nothing
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Patients who are hospitalized or outpatient at Showa University Karasuyama Hospital. 2) Patients whose age at the time of obtaining consent is between 20 and 75 years old. 3) Patients who have been given the same type and amount of long-acting injection 3 times or more by the time consent is obtained. 4) Patients who have given written consent to participate in this study.
Key exclusion criteria	1)Patients who are contraindicated for topical use of lidocaine / propitocaine combination cream, 10% urea cream white petrolatum 2) Patients who are hospitalized for measures at the time of obtaining consent 3) Patients who are judged to be ineligible by the judgment of the research doctor.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name TOSHIAKI Middle name Last name TSUNEOKA
Organization	Showa University Karasuyama Hospital
Division name	Department of Psychiatry, School of Medicine, Showa University
Zip code	1578577
Address	6-11-11 Kita-Karasuyama, Setagaya, Tokyo, Japan
TEL	0333005231
Email	tsune1027@hotmail.com

Public contact
Name of contact person	1st name TOSHIAKI Middle name Last name TSUNEOKA
Organization	Showa University Karasuyama Hospital
Division name	Department of Psychiatry, School of Medicine, Showa University
Zip code	1578577
Address	6-11-11 Kita-Karasuyama, Setagaya, Tokyo, Japan
TEL	0333005231
Homepage URL
Email	tsune1027@hotmail.com

Sponsor
Institute	Showa University
Institute
Department

Funding Source
Organization	Showa University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	lnstitutional Review Board of ShowaUniversity Karasuyama Hospital
Address	6-11-11 Kitakarasuyama,Setagaya-ku,Tokyo,157-8577 Japan
Tel	0333005231
Email	tsune1027@hotmail.com

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	2021 Year 03 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	30
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	2019 Year 06 Month 26 Day
Date of IRB	2019 Year 07 Month 12 Day
Anticipated trial start date	2019 Year 07 Month 12 Day
Last follow-up date	2020 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 03 Month 23 Day
Last modified on	2021 Year 03 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049909