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NCT03345342 · ClinicalTrials.gov registry record · Phase 3
A Study of Paliperidone Palmitate 6-Month Formulation
A Phase 3 study of Schizophrenia, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 841
- Enrollment target
- 20
- Study locations
NCT03345342: Completed Phase 3 study of Schizophrenia, sponsored by Janssen Research & Development.
NCT03345342 is a Phase 3 study of Schizophrenia that has completed, run by Janssen Research & Development. The registered enrollment target is 841 participants, above the 216-participant average among 315 other Schizophrenia trials with a reported enrollment target (289% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03345342, a Phase 3 study of Schizophrenia, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 841 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to demonstrate that injection cycles consisting of a single administration of paliperidone palmitate 6-month (PP6M) are not less effective than 2 sequentially administered injections of paliperidone palmitate 3-month PP3M) (350 or 525 mg eq.) for the prevention of relapse in participants with schizophrenia previously stabilized on corresponding doses of paliperidone palmitate 1-month (PP1M) (100 or 150 mg eq.) or PP3M (350 or 525 mg eq.).
Primary Outcome
Time to relapse is time between participant randomization in DB Phase and first documentation of relapse event by end of Month 12 of DB phase. Relapse is defined as: a) Psychiatric hospitalization; b) Positive and Negative Syndrome Scale (PANSS) total score: Increase of 25 percentage (%), 10 point increase in PANSS for 2 analysis separated by 3-7 days if score was greater than (\>) 40, less than or equal to (\<=)40; c) Participants inflicted knowing self-injury/shown violent behavior leading to
Conditions Studied
Interventions
- OTHER Placebo
- DRUG PP6M
- DRUG PP3M 350 mg eq.
- DRUG PP3M 525 mg eq.
- DRUG PP1M
Study Locations (20)
California
- California Pharmaceutical Research Institute, Inc. - Anaheim
- ATP Clinical Research - Costa Mesa
- Collaborative NeuroScience Network - Garden Grove
- Synergy East - Lemon Grove
- Pacific Research Partners - Oakland
- SF-Care, Inc - San Rafael
Florida
- New Life Medical Research Center, Inc. - Hialeah
- Clintex Research Group - Miami
- Florida Research Center Inc. - Miami
- Olympian Clinical Research - Tampa
Illinois
- Uptown Research Institute - Chicago
- Alexian Behavioral Health Hospital - Hoffman Estates
Arkansas
- Woodland Research Northwest - Rogers
Georgia
- Atlanta Center for Medical Research - Atlanta
Kansas
- Ascension via Christi Research - Wichita
Massachusetts
- Massachusetts General Hospital - Boston
Michigan
- Cherry Street Services, Inc. - Grand Rapids
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 841 participants |
| Start Date | 2017-11-20 |
| Est. Completion | 2020-05-08 |
| Phase | Phase 3 |
What the finished NCT03345342 record still lists
NCT03345342 is an interventional study that assigns participants to a tested intervention. The registered 841 participants enrollment target is mid-sized for trials with a published cap, above the 216-participant average among 315 other Schizophrenia trials with a reported enrollment target (289% higher).
The record links to 1 condition, with Schizophrenia appearing as the primary indexed condition, and to 5 interventions - of which Placebo is the first listed.
NCT03345342 names 20 study sites across 11 states, led by California, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT03345342 about?
NCT03345342 is a clinical study titled "A Study of Paliperidone Palmitate 6-Month Formulation". The purpose of this study is to demonstrate that injection cycles consisting of a single administration of paliperidone palmitate 6-month (PP6M) are not less effective than 2 sequentially administered injections of paliperidone palmitate 3-month PP3M) (350 or 525 mg eq.) for the prevention of relaps...
What is the current status of trial NCT03345342?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 841 participants. The study started on 2017-11-20. Estimated completion is 2020-05-08.
What conditions does trial NCT03345342 study?
This clinical trial studies the following conditions: Schizophrenia.
What interventions are being tested in trial NCT03345342?
The interventions under investigation include: Placebo (OTHER), PP6M (DRUG), PP3M 350 mg eq. (DRUG), PP3M 525 mg eq. (DRUG), PP1M (DRUG).
Who is sponsoring clinical trial NCT03345342?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03345342 being conducted?
This trial has 20 study locations across Arkansas, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03345342's enrollment target sits among peer trials
841 12th of 315 higher than 304 of 315 other Schizophrenia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Schizophrenia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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