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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036808
Receipt No. R000041939
Scientific Title Special drug use-results survey on ERLEADA 60 mg Tablets (Long-term use in patients with non-distant metastatic castration-resistant prostate cancer)
Date of disclosure of the study information 2019/05/31
Last modified on 2019/06/19

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Basic information
Public title Special drug use-results survey on ERLEADA 60 mg Tablets (Long-term use in patients with non-distant metastatic castration-resistant prostate cancer)
Acronym ELD1L
Scientific Title Special drug use-results survey on ERLEADA 60 mg Tablets (Long-term use in patients with non-distant metastatic castration-resistant prostate cancer)
Scientific Title:Acronym ELD1L
Region
Japan

Condition
Condition non-distant metastatic castration-resistant prostate cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the incidence of seizures and severe skin disorder in patients with non-distant metastatic castration-resistant prostate cancer who receive long-term treatment with ERLEADA 60 mg Tablets (hereinafter referred to as ERLEADA) in regular clinical practice.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes [Patient composition]
(a) Number of patients registered
(b) Number of patients whose CRFs were collected
(c) Number of patients for safety analysis
(d) Number of patients excluded for analysis and the reason for exclusion
[Safety analysis]
(a) Incidence of safety specifications
(b) Factors considered affecting safety specification (incidence by patient background, etc.)
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
Key inclusion criteria Patients with non-distant metastatic castration-resistant prostate cancer who received ERLEADA for the first time are targeted.
The target patients must understand the contents of this survey and give consent to participation.
Key exclusion criteria Patients with a history of the use of Apalutamide
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Toshiya
Middle name
Last name Kato
Organization Janssen Pharmaceutical K.K.
Division name Safety Risk Management Dept.
Zip code 101-0065
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 Sayuri
Middle name
Last name Harada
Organization Janssen Pharmaceutical K.K.
Division name Safety Risk Management Dept.
Zip code 101-0065
Address 5-2, Nishi-kanda, 3-Chome, Chiyoda-ku, Tokyo
TEL 03-4411-5874
Homepage URL
Email sharada8@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 Janssen Pharmaceutical K.K.
Address 5-2, Nishi-kanda, 3-Chome, Chiyoda-ku, Tokyo
Tel 03-4411-5874
Email sharada8@its.jnj.com

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
2019 Year 05 Month 31 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
2019 Year 04 Month 12 Day
Date of IRB
2019 Year 04 Month 12 Day
Anticipated trial start date
2019 Year 05 Month 30 Day
Last follow-up date
2023 Year 11 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observation period: For 12 months (52 weeks) from the launch date for ERLEADA

Management information
Registered date
2019 Year 05 Month 21 Day
Last modified on
2019 Year 06 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041939

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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