UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001945 |
|---|---|
| Receipt number | R000002367 |
| Scientific Title | Clinical effectiveness of Donepezil Hydrochloride for radiation-induced memory disturbance in patients with brain tumor |
| Date of disclosure of the study information | 2009/06/01 |
| Last modified on | 2016/05/09 16:37:08 |
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Basic information
Public title
Clinical effectiveness of Donepezil Hydrochloride for radiation-induced memory disturbance in patients with brain tumor
Acronym
Clinical effectiveness of Donepezil Hydrochloride for radiation-induced memory disturbance in patients with brain tumor
Scientific Title
Clinical effectiveness of Donepezil Hydrochloride for radiation-induced memory disturbance in patients with brain tumor
Scientific Title:Acronym
Clinical effectiveness of Donepezil Hydrochloride for radiation-induced memory disturbance in patients with brain tumor
Region
| Japan |
Condition
Condition
brain tumor
Classification by specialty
| Radiology | Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate clinical effectiveness of Donepezil Hydrochloride to radiation-induced memory disturbance in patients with brain tumor
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Improvement of memory disturbance
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Donepezil Hydrochloride
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
1. no history of radiation therapy to brain
2. expect more than 6 months survival
3. patiets with small cell lung cancer who will receive prophylactic cranial irradiation
4.patiets with multiple brain tumors, without midline shift, nor without huge tumors of more than 5cm diameter
5.patients without disease of contra-indication to Donepezil Hydrochloride
Key exclusion criteria
Patients of contra-indication to Donepezil Hydrochloride
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryohei Sasaki |
Organization
Kobe University Hospital
Division name
Division of Radiation Oncology
Zip code
Address
7-5-2 Kusunokicho Chuouku Kobe city
TEL
078-382-6104
rsasaki@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuo Ejima |
Organization
Kobe University Hospital
Division name
Division of Radiation Oncology
Zip code
Address
7-5-2 Kusunokicho Chuouku Kobe city
TEL
078-382-6104
Homepage URL
ejimay@med.kobe-u.ac.jp
Sponsor or person
Institute
Department od Radiology, Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department od Radiology, Kobe University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Other
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
| 2009 | 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
Open public recruiting
Date of protocol fixation
| 2009 | Year | 05 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 06 | 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
| 2009 | Year | 05 | Month | 07 | Day |
Last modified on
| 2016 | 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=R000002367
