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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

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 - TRI1L

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000042033
Enrollment
1050
Registered
2020-12-01
Start date
2020-12-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Interventions

None listed

Sponsors

Janssen Pharmaceutical K.K.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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)

Exclusion criteria

Exclusion criteria: Patients not meeting Key inclusion criteria

Design outcomes

Primary

MeasureTime frame
Incidence of adverse events related to QT prolongation (Includes relevant laboratory tests.), Concomitant use of oral antipsychotics, etc., Adherence (Treatment Compliance)

Countries

Japan

Contacts

Public ContactKeiko Kawamura

Janssen Pharma Medical Affairs Delivery Unit

KKawamu8@ITS.JNJ.com+81-70-26518146

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026