UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027774
Receipt No. R000028425
Scientific Title Finding out causes of breakthrough pain focused on circadian rhythm-related factors
Date of disclosure of the study information 2017/06/16
Last modified on 2018/12/16

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Finding out causes of breakthrough pain focused on circadian rhythm-related factors
Acronym Finding out causes of breakthrough pain focused on circadian rhythm-related factors
Scientific Title Finding out causes of breakthrough pain focused on circadian rhythm-related factors
Scientific Title:Acronym Finding out causes of breakthrough pain focused on circadian rhythm-related factors
Region
Japan

Condition
Condition Cancer, Sleep disorder, Circadian rhythm disorder
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To reveal the relationship between breakthrough pain and circadian rhythm related factors
Basic objectives2 Others
Basic objectives -Others The relationship
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The relationship between breakthrough pain and circadian rhythm related factors
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Subjects will be received following two interventions for three days.
1.Recording the time of breakthrough pain and the degree of pain (NRS).
2.Measuring circadian rhythm related factors (actigraph, Saint Mary's hospital sleep questionnaire, urine 6-sulfatoxymelatonin and so on).
In addition, assessment anxiety and depression by HAD at getting informed consent.

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Cancer patients without changing opioid medication for more than three days.
Key exclusion criteria Cancer patients with heavy dementia, <= PS2, on anticancer drug medicaton.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuyuki Niki
Organization Osaka University/Ashiya Municipal Hospital
Division name Graduate School of Pharmaceutical Sciences/Department of Pharmacy
Zip code
Address Osaka, Suita, Yamadaoka1-6/Hyogo, Ashiya, Asahigaokacho 39-1
TEL 06-6879-8250
Email k-niki@phs.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuyuki Niki
Organization Osaka University/Ashiya Municipal Hospital
Division name Graduate School of Pharmaceutical Sciences/Department of Pharmacy
Zip code
Address Osaka, Suita, Yamadaoka1-6/Hyogo, Ashiya, Asahigaokacho 39-1
TEL 06-6879-8250
Homepage URL
Email k-niki@phs.osaka-u.ac.jp

Sponsor
Institute Osaka University
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
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 06 Month 16 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
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 Enrolling by invitation
Date of protocol fixation
2016 Year 11 Month 30 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 06 Month 15 Day
Last modified on
2018 Year 12 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028425

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.