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NCT02203838 · ClinicalTrials.gov registry record · Phase 3
Long Term Study of RBP 7000 in the Treatment of Subjects With Schizophrenia
A Phase 3 study, sponsored by Indivior.
- Completed
- Registry status
- Phase 3
- Development phase
- 500
- Enrollment target
NCT02203838: Completed Phase 3 study, sponsored by Indivior.
NCT02203838 is a Phase 3 study that has completed, run by Indivior. The registered enrollment target is 500 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02203838, a Phase 3 study, has completed, sponsored by Indivior.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 500 participants
- Enrollment target
Study Summary
This is a Phase 3, open label study administering RBP-7000 in the treatment of patients with schizophrenia. Study will assess the long-term safety and tolerability of RBP-7000 subcutaneous (SC) injections in subjects with schizophrenia and to continue collecting clinical outcome data with RBP-7000 SC injections in subjects with schizophrenia using the Positive and Negative Syndrome Scale (PANSS) and Clinical Global Impression-Severity Illness (CGI-S) scale.
Primary Outcome
An adverse event (AE) is defined as any study-related event that represents a change (positive or negative) in frequency or severity from a baseline (prestudy) event (if any), regardless of the presence of causal relationship or medical significance. Treatment-emergent adverse events are defined as any adverse event with a start date on or after the first study dose date. AEs are determined by the Investigator to be related or not related to the study drug. A serious AE (SAE) is defined by fede
Interventions
- DRUG RBP-7000
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2014-06 |
| Est. Completion | 2016-09 |
| Phase | Phase 3 |
What the finished NCT02203838 record still lists
NCT02203838 is an interventional study that assigns participants to a tested intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% lower).
The record links to 0 conditions, and to 1 intervention - of which RBP-7000 is the first listed.
NCT02203838 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02203838 about?
NCT02203838 is a clinical study titled "Long Term Study of RBP 7000 in the Treatment of Subjects With Schizophrenia". This is a Phase 3, open label study administering RBP-7000 in the treatment of patients with schizophrenia. Study will assess the long-term safety and tolerability of RBP-7000 subcutaneous (SC) injections in subjects with schizophrenia and to continue collecting clinical outcome data with RBP-7000 S...
What is the current status of trial NCT02203838?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 500 participants. The study started on 2014-06. Estimated completion is 2016-09.
What interventions are being tested in trial NCT02203838?
The interventions under investigation include: RBP-7000 (DRUG).
Who is sponsoring clinical trial NCT02203838?
This trial is sponsored by Indivior, which has 37 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02203838's enrollment target sits among peer trials
500 744th of 2000 higher than 1,226 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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