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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000043711
Receipt No. R000049909
Scientific Title Effect of using of local anesthesia for injection pain due to long-acting injectable antipsychotics
Date of disclosure of the study information 2021/03/23
Last modified on 2021/03/23

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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

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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