UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043869 |
|---|---|
| Receipt number | R000050064 |
| Scientific Title | The efficacy and safety of intravenous chlorpromazine treatment for sleep disturbance in incurable cancer patients with difficulty receiving oral administration. |
| Date of disclosure of the study information | 2021/04/08 |
| Last modified on | 2021/04/08 16:16:56 |
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Basic information
Public title
The efficacy and safety of intravenous chlorpromazine treatment for sleep disturbance in incurable cancer patients with difficulty receiving oral administration.
Acronym
The efficacy and safety of intravenous chlorpromazine treatment for sleep disturbance.
Scientific Title
The efficacy and safety of intravenous chlorpromazine treatment for sleep disturbance in incurable cancer patients with difficulty receiving oral administration.
Scientific Title:Acronym
The efficacy and safety of intravenous chlorpromazine treatment for sleep disturbance.
Region
| Japan |
Condition
Condition
sleep disturbance in incurable cancer
patients
Classification by specialty
| Psychosomatic Internal Medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Re-evaluate the efficacy and safety of intravenous chlorpromazine treatment for sleep disturbances and to determine the feasibility seven days after the dose.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The efficacy rate of the St. Marys Hospital sleep questionnaire on sleep quality seven days after the intravenous chlorpromazine dose.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The incurable cancer patients with difficulty receiving oral administration diagnosed with sleep disturbances using the American Psychiatric Association's diagnostic criteria (DSM-V).
Key exclusion criteria
mental disorders such as dementia, which would create difficulties in completing St. Marys Hospital sleep questionnaire.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Ryohei |
| Middle name | |
| Last name | Fujii |
Organization
Kansai Medical University Hospital
Division name
Department of Pharmacist
Zip code
573-1191
Address
2-3-1 Shinmachi, Hirakata, Osaka
TEL
072-804-0101
fujiir@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Ryohei |
| Middle name | |
| Last name | Fujii |
Organization
Kansai Medical University Hospital
Division name
Department of Pharmacist
Zip code
573-1191
Address
2-3-1 Shinmachi, Hirakata, Osaka
TEL
072-804-0101
Homepage URL
fujiir@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Kansai Medical University Ethics Review Committee
Address
2-5-1 Shinmachi, Hirakata, Osaka
Tel
072-804-2440
rinriirb@hirakata.kumu.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 04 | Month | 08 | 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
52
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
| 2018 | Year | 05 | Month | 22 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 31 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
It was found that the safety of intravenous chlorpromazine is high.
Management information
Registered date
| 2021 | Year | 04 | Month | 08 | Day |
Last modified on
| 2021 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050064
