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NCT02896296 · ClinicalTrials.gov registry record · Phase 3
Open-Label Treatment Extension Study
A Phase 3 study of Opioid Use Disorder and Opioid-Related Disorders, sponsored by Indivior.
- Completed
- Registry status
- Phase 3
- Development phase
- 208
- Enrollment target
- 20
- Study locations
NCT02896296: Completed Phase 3 study of Opioid Use Disorder and Opioid-Related Disorders, sponsored by Indivior.
NCT02896296 is a Phase 3 study of Opioid Use Disorder and Opioid-Related Disorders that has completed, run by Indivior. The registered enrollment target is 208 participants, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (96% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02896296, a Phase 3 study of Opioid Use Disorder and Opioid-Related Disorders, has completed, sponsored by Indivior.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 208 participants
- Enrollment target
- 20
- Study locations
Study Summary
Study is to provide ongoing treatment with RBP-6000 and safety monitoring for subjects who complete the RB-US-13-0003 study (NCT02510014) and for whom a new treatment venue has not been identified or arranged.
Primary Outcome
TEAE=any untoward medical occurrence that develops or worsens in severity after dispensation of the study drug and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= a marked limitation in activity. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalizati
Conditions Studied
Interventions
- DRUG RBP-6000
Study Locations (20)
Florida
- Sarkis Clinical Trials - Gainesville
- Amit Vijapura - Jacksonville
- Meridien Research - Lakeland
- Innovative Clinical Research - Lauderhill
- Scientific Clinical Research - North Miami
California
- Collaborative Neuroscience Network - Long Beach
- Pacific Research Partners - Oakland
Louisiana
- Louisiana Research Associates - New Orleans
- Louisiana Clinical Research - Shreveport
Massachusetts
- Stanley Street Treatment and Resources - Fall River
- Adams Clinical Trials - Watertown
New Jersey
- Hassman Research Institute - Berlin
- Center for Emotional Fitness - Cherry Hill
Alabama
- Boyett Health Services - Hamilton
Arkansas
- Woodland International Research Group - Little Rock
Kansas
- Phoenix Medical Research - Prairie Village
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 208 participants |
| Start Date | 2016-08-17 |
| Est. Completion | 2017-08-23 |
| Phase | Phase 3 |
What the finished NCT02896296 record still lists
NCT02896296 is an interventional study that assigns participants to a tested intervention. The registered 208 participants enrollment target is mid-sized for trials with a published cap, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (96% lower).
The record links to 2 conditions, with Opioid Use Disorder appearing as the primary indexed condition, and to 1 intervention - of which RBP-6000 is the first listed.
NCT02896296 names 20 study sites across 12 states, led by Florida, California, Louisiana.
Frequently Asked Questions
What is clinical trial NCT02896296 about?
NCT02896296 is a clinical study titled "Open-Label Treatment Extension Study". Study is to provide ongoing treatment with RBP-6000 and safety monitoring for subjects who complete the RB-US-13-0003 study (NCT02510014) and for whom a new treatment venue has not been identified or arranged.
What is the current status of trial NCT02896296?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 208 participants. The study started on 2016-08-17. Estimated completion is 2017-08-23.
What conditions does trial NCT02896296 study?
This clinical trial studies the following conditions: Opioid Use Disorder, Opioid-Related Disorders.
What interventions are being tested in trial NCT02896296?
The interventions under investigation include: RBP-6000 (DRUG).
Who is sponsoring clinical trial NCT02896296?
This trial is sponsored by Indivior, which has 37 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02896296 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Florida, Kansas. 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 NCT02896296's enrollment target sits among peer trials
208 89th of 257 higher than 169 of 257 other Opioid Use Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Opioid Use Disorder 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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