UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029365 |
|---|---|
| Receipt number | R000033560 |
| Scientific Title | Intravenous chlorpromazine for the treatment of insomnia in end-stage cancer patients with difficulty in oral administration |
| Date of disclosure of the study information | 2017/10/01 |
| Last modified on | 2017/10/01 14:34:04 |
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Basic information
Public title
Intravenous chlorpromazine for the treatment of insomnia in end-stage cancer patients with difficulty in oral administration
Acronym
Intravenous chlorpromazine for the treatment of insomnia
Scientific Title
Intravenous chlorpromazine for the treatment of insomnia in end-stage cancer patients with difficulty in oral administration
Scientific Title:Acronym
Intravenous chlorpromazine for the treatment of insomnia
Region
| Japan |
Condition
Condition
sleep disturbance
Classification by specialty
| Psychiatry |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of the study was to evaluate efficacy and safety of intravenous chlorpromazine for the treatment of insomnia in end-stage cancer patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary endpoint in this study was sleep quality based on St. Marys Hospital Sleep Questionnaire 3 days after the chlorpromazine treatment as a chlorpromazine efficacy index.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Study subjects were 30 end-stage cancer patients with difficulty in oral administration from whom the informed consent for intravenous chlorpromazine was obtained.
Key exclusion criteria
We focused on only primary insomnia excluding secondary insomnia attributed to delirium or medications.
The study excluded psychiatric disorder patients with difficulty in communication such as dementia.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideaki Hasuo |
Organization
Kansai Medical University
Division name
Department of Psychosomatic Medicine
Zip code
Address
Shinmachi 2-5-1, Hirakata, Osaka
TEL
072-804-0101
hasuohid@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideaki Hasuo |
Organization
Kansai Medical University
Division name
Department of Psychosomatic Medicine
Zip code
Address
Shinmachi 2-5-1, Hirakata, Osaka
TEL
072-804-0101
Homepage URL
hasuohid@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
Kansai Medical 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
Address
Tel
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
| 2017 | Year | 10 | Month | 01 | 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
Sleep quality was significantly improved on the day after intravenous chlorpromazine and later.Efficacy rate 3 days after the intravenous chlorpromazine was 0.63 (95% CI: 0.45-0.81). Increased total sleep time and decreased sleep latency time were observed on the day after the treatment, accompanied with improvement of satisfaction with sleep and clearheadedness on arising.On the other hand, no significant improvement was not observed in depth of sleep or number of awakenings during sleep time.
After the chlorpromazine treatment, 2 patients dropped out due to difficulty in communication caused by the development of hypoactive delirium.There were no onsets of acute extrapyramidal symptoms, fall, vasculitis, or subcutaneous callus during the treatment.
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
| 2015 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2017 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 09 | Month | 30 | Day |
Other
Other related information
We retrospectively evaluated 30 end-stage cancer patients with difficulty in oral administration that received intravenous chlorpromazine for the treatment of insomnia.
Management information
Registered date
| 2017 | Year | 10 | Month | 01 | Day |
Last modified on
| 2017 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033560
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
