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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017151
Receipt No. R000019898
Scientific Title Special Drug Use-results survey for long term administration of Reminyl 4mg/8mg/12mg Tablets, 4mg/8mg/12mg OD Tablets, 4mg/mL Oral Solution
Date of disclosure of the study information 2015/04/20
Last modified on 2019/03/06

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Basic information
Public title Special Drug Use-results survey for long term administration of Reminyl 4mg/8mg/12mg Tablets, 4mg/8mg/12mg OD Tablets, 4mg/mL Oral Solution
Acronym Special Drug Use-results survey for long term administration of Reminyl 4mg/8mg/12mg Tablets, 4mg/8mg/12mg OD Tablets, 4mg/mL Oral Solution
Scientific Title Special Drug Use-results survey for long term administration of Reminyl 4mg/8mg/12mg Tablets, 4mg/8mg/12mg OD Tablets, 4mg/mL Oral Solution
Scientific Title:Acronym Special Drug Use-results survey for long term administration of Reminyl 4mg/8mg/12mg Tablets, 4mg/8mg/12mg OD Tablets, 4mg/mL Oral Solution
Region
Japan

Condition
Condition Mild to moderately severe dementia of the Alzheimer's type
Classification by specialty
Neurology Psychosomatic Internal Medicine Geriatrics
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To collect, screen or confirm or verify information relating to efficacy and safety of long term administration of Reminyl 4mg/8mg/12mg tablets, 4mg/8mg/12mg OD tablets, 4mg/mL oral solution in actual medical practice.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Safety (Adverse Drug Reactions)
Efficacy (Mini-Mental State Examination, Clinical Global Impression-Improvement scale, Medication Satisfaction Questionnaire of caretaker)
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with mild to moderately severe dementia of the Alzheimer's type who was admnistered Reminyl for the first time
Key exclusion criteria NA
Target sample size 600

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiya Kato
Organization Janssen Pharmaceutical K.K.
Division name Safety Risk Management Dept.
Zip code
Address 5-2, Nishi-Kanda 3-chome, Chiyoda-ku, Tokyo
TEL 03-4411-5478
Email tkato1@its.jnj.com

Public contact
Name of contact person
1st name
Middle name
Last name Hirokazu Shirai
Organization Janssen Pharmaceutical K.K.
Division name Safety Risk Management Dept.
Zip code
Address 5-2, Nishi-Kanda 3-chome, Chiyoda-ku, Tokyo
TEL 03-4411-5951
Homepage URL
Email hshirai3@ITS.JNJ.com

Sponsor
Institute Janssen Pharmaceutical K.K.
Institute
Department

Funding Source
Organization Janssen Pharmaceutical K.K.
Organization
Division
Category of Funding Organization Profit organization
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
2015 Year 04 Month 20 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Completed
Date of protocol fixation
2010 Year 12 Month 07 Day
Date of IRB
Anticipated trial start date
2011 Year 04 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective study

Management information
Registered date
2015 Year 04 Month 16 Day
Last modified on
2019 Year 03 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019898

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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