UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042033 |
|---|---|
| Receipt number | 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 | 2023/10/10 09:07:01 |
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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
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
hkinosh4@its.jnj.com
Sponsor or person
Institute
Janssen Pharma
Institute
Department
Personal name
Funding Source
Organization
Janssen Pharma
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 Pharma
Address
5-2 Nishikanda, 3-chome
Tel
81344115484
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
990
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 09 | Month | 29 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 29 | Day |
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
| 2024 | Year | 09 | Month | 24 | Day |
Date trial data considered complete
| 2024 | Year | 09 | Month | 25 | Day |
Date analysis concluded
| 2024 | Year | 12 | Month | 24 | Day |
Other
Other related information
Nothing in particular
Management information
Registered date
| 2020 | Year | 10 | Month | 07 | Day |
Last modified on
| 2023 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047973
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
