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NCT01848054 · ClinicalTrials.gov registry record · Phase 3
Study to Assess Efficacy and Safety of BNX Sublingual Tablets for the Induction of Treatment of Opioid Dependence
A Phase 3 study of Opioid-Related Disorders and Opiate Dependence, sponsored by Orexo AB.
- Completed
- Registry status
- Phase 3
- Development phase
- 313
- Enrollment target
- 14
- Study locations
NCT01848054 is a Phase 3 study of Opioid-Related Disorders and Opiate Dependence that has completed, run by Orexo AB. The registered enrollment target is 313 participants, roughly in line with the 340-participant average among 47 other Opioid-Related Disorders trials with a reported enrollment target. The trial reports 14 study locations across 10 states.
The verdict
NCT01848054, a Phase 3 study of Opioid-Related Disorders and Opiate Dependence, has completed, sponsored by Orexo AB.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 313 participants
- Enrollment target
- 14
- Study locations
Study Summary
The purpose of the study was to assess the efficacy of induction treatment with buprenorphine/naloxone (BNX) sublingual tablet s compared with induction treatment with buprenorphine only. The hypothesis is that starting directly on OX219 works equally well (e.g. not significantly worse) as starting on buprenorphine only and switching to OX219 on Day 3.
Conditions Studied
Interventions
- DRUG Buprenorphine
- DRUG Buprenorphine/naloxone sublingual tablets
Study Locations (14)
Florida
- - Jacksonville
- - Maitland
- - North Miami
Alabama
- - Birmingham
- - Haleyville
California
- - National City
- - Oceanside
Maryland
- - Baltimore
Massachusetts
- - Fall River
Mississippi
- - Flowood
Pennsylvania
- - Philadelphia
South Carolina
- - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 313 participants |
| Start Date | 2013-06 |
| Est. Completion | 2014-01 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01848054
The ClinicalTrials.gov registry entry for NCT01848054 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 313 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 340-participant average among 47 other Opioid-Related Disorders trials with a reported enrollment target. The listed sponsor is Orexo AB, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Opioid-Related Disorders appearing as the primary indexed condition, and to 2 interventions - of which Buprenorphine is the first listed.
NCT01848054 reports 14 study locations spanning 10 distinct geographic areas - top geographies include Florida, Alabama, California.
Frequently Asked Questions
What is clinical trial NCT01848054 about?
NCT01848054 is a clinical study titled "Study to Assess Efficacy and Safety of BNX Sublingual Tablets for the Induction of Treatment of Opioid Dependence". The purpose of the study was to assess the efficacy of induction treatment with buprenorphine/naloxone (BNX) sublingual tablet s compared with induction treatment with buprenorphine only. The hypothesis is that starting directly on OX219 works equally well (e.g. not significantly worse) as starting ...
What is the current status of trial NCT01848054?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 313 participants. The study started on 2013-06. Estimated completion is 2014-01.
What conditions does trial NCT01848054 study?
This clinical trial studies the following conditions: Opioid-Related Disorders, Opiate Dependence.
What interventions are being tested in trial NCT01848054?
The interventions under investigation include: Buprenorphine (DRUG), Buprenorphine/naloxone sublingual tablets (DRUG).
Who is sponsoring clinical trial NCT01848054?
This trial is sponsored by Orexo AB, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01848054 being conducted?
This trial has 14 study locations across Alabama, California, Florida, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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