UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043711 |
|---|---|
| Receipt number | 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 02:23:19 |
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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
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
tsune1027@hotmail.com
Sponsor or person
Institute
Showa University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049909
