UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000001945
Receipt No. 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

* 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 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
Email 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
Email ejimay@med.kobe-u.ac.jp

Sponsor
Institute Department od Radiology, Kobe University Graduate School of Medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002367

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.