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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029365
Receipt No. 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

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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
Email 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
Email hasuohid@hirakata.kmu.ac.jp

Sponsor
Institute Kansai Medical University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033560

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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