UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054351 |
|---|---|
| Receipt number | R000062085 |
| Scientific Title | Prospective randomized controlled trial between lemborexant and benzodiazepine for pancreatobiliary patients with high risk factor of delirium |
| Date of disclosure of the study information | 2024/06/01 |
| Last modified on | 2024/05/09 14:05:12 |
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Basic information
Public title
Prospective randomized controlled trial between lemborexant and benzodiazepine for pancreatobiliary patients with high risk factor of delirium
Acronym
Prospective randomized controlled trial between lemborexant and benzodiazepine for pancreatobiliary patients with high risk factor of delirium
Scientific Title
Prospective randomized controlled trial between lemborexant and benzodiazepine for pancreatobiliary patients with high risk factor of delirium
Scientific Title:Acronym
Prospective randomized controlled trial between lemborexant and benzodiazepine for pancreatobiliary patients with high risk factor of delirium
Region
| Japan |
Condition
Condition
Pancreatobiliary patents with high risk factor of delirium
Classification by specialty
| Hepato-biliary-pancreatic medicine | Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the incidence rate of delirium between benzodiazepine and lemborexant in pancreatobiliary patents with high risk factor of delirium
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence rate of delirium
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
benzodiazepine
Interventions/Control_2
lemborexant
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
| 18 | years-old | <= |
Age-upper limit
| 99 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1 Inpatients with pancreatobiliary disease
2 Patients who are complicated with risk factor associated with delirium
3 Complicating with insomnia
4 Age 18-99
Key exclusion criteria
1 Undertaken antipsychotic drugs
2 Undertaken sleeping pills
3 Refusal to participate this study
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Ogura |
Organization
Osaka Medical and Pharmaceutical University Hospital
Division name
Endoscopy Center
Zip code
569-8686
Address
2-7 Daigakuchou, Takatsukishi, Osaka
TEL
072-683-1221
oguratakeshi0411@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Ogura |
Organization
Osaka Medical and Pharmaceutical University Hospital
Division name
Endoscopy Center
Zip code
569-8686
Address
2-7 Daigakuchou, Takatsukishi, Osaka
TEL
072-683-1221
Homepage URL
oguratakeshi0411@yahoo.co.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical and Pharmaceutical 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
Osaka Medical and Pharmaceutical University Research Ethics Committee
Address
2-7 Daigakuchou, Takatsukishi, Osaka
Tel
072-683-1221
rinri@ompu.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
| 2024 | Year | 06 | 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
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
Preinitiation
Date of protocol fixation
| 2024 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 05 | Month | 09 | Day |
Last modified on
| 2024 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062085
