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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042033
Receipt No. R000047973
Scientific Title Special Drug Use-Results Survey for Long-term Use of XEPLION TRI Aqueous Suspension for IM Injection 175 mg, 263 mg, 350 mg, and 525 mg Syringe
Date of disclosure of the study information 2020/12/01
Last modified on 2020/10/07

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Basic information
Public title Special Drug Use-Results Survey for Long-term Use of XEPLION TRI Aqueous Suspension for IM Injection 175 mg, 263 mg, 350 mg, and 525 mg Syringe
Acronym TRI1L
Scientific Title Special Drug Use-Results Survey for Long-term Use of XEPLION TRI Aqueous Suspension for IM Injection 175 mg, 263 mg, 350 mg, and 525 mg Syringe
Scientific Title:Acronym TRI1L
Region
Japan

Condition
Condition Schizophrenia
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate safety and adherence in clinical use for long-term use of XEPLION TRI Aqueous Suspension for IM Injection 175 mg, 263 mg, 350 mg, and 525 mg Syringe (hereinafter referred to as the drug).
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Incidence of adverse events related to QT prolongation (Includes relevant laboratory tests.), Concomitant use of oral antipsychotics, etc., Adherence (Treatment Compliance)
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who meet all of the following A to D (Confirm the eligibility of subjects at the time of registration.)
A. Patients who have been continuously treated with paliperidone palmitate sustained-release suspension for injection in an intramuscular fashion for 4 weeks (Hereinafter referred to as "Paliperidone 4-Week Subcutaneous Intramuscular Injection") without concomitant use of other antipsychotics for at least 4 months in patients with schizophrenia, and in whom the safety and tolerability were confirmed.
B. Patients who switched to this drug 4 weeks after the last dose of paliperidone 4 weeks after the last dose of paliperidone.
C. Paliperidone at the same dose in at least the last 2 4-week IM injections prior to switching.
D. Patients who understand the contents of this investigation and agree to participate in the investigation (Informed Consent)
Key exclusion criteria Patients not meeting Key inclusion criteria
Target sample size 1050

Research contact person
Name of lead principal investigator
1st name Hiroaki
Middle name
Last name Kinoshita
Organization Janssen Pharma KK
Division name Safety Risk Management Dept.
Zip code 112-0002
Address Chiyoda-ku
TEL 81344115484
Email hkinosh4@its.jnj.com

Public contact
Name of contact person
1st name Hiroaki
Middle name
Last name Kinoshita
Organization Janssen Pharma
Division name Safety Risk Management Dept.
Zip code 112-0002
Address Chiyoda-ku
TEL 81344115484
Homepage URL
Email hkinosh4@its.jnj.com

Sponsor
Institute Janssen Pharma
Institute
Department

Funding Source
Organization Janssen Pharma
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization 38

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Janssen Pharma
Address 5-2 Nishikanda, 3-chome
Tel 81344115484
Email hkinosh4@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
2020 Year 12 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
2020 Year 09 Month 29 Day
Date of IRB
Anticipated trial start date
2020 Year 12 Month 01 Day
Last follow-up date
2024 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Nothing in particular

Management information
Registered date
2020 Year 10 Month 07 Day
Last modified on
2020 Year 10 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047973

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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