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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: Completed Phase 3 study of Opioid-Related Disorders and Opiate Dependence, sponsored by Orexo AB.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Retention in treatment at Day 3 in the per protocol population (n=256) was defined as the number of patients in each induction arm completing the induction phase and who received study medication on Day 3. Treatment with BNX sublingual tablets was considered non-inferior to generic buprenorphine if the lower limit of the 95% confidence interval for the difference between BNX and generic buprenorphine was ≥-10% in the number of patients retained in treatment on Day 3.

Conditions Studied

Opioid-Related Disorders Opiate Dependence

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

FieldValue
Enrollment Target 313 participants
Start Date 2013-06
Est. Completion 2014-01
Phase Phase 3
Orexo AB

4 total trials

What the finished NCT01848054 record still lists

NCT01848054 is an interventional study that assigns participants to a tested intervention. The registered 313 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 340-participant average among 47 other Opioid-Related Disorders trials with a reported enrollment target.

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 lists 14 locations in 10 states (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.

Learn More About Clinical Trials

Similar trials for Opioid-Related Disorders

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 NCT01848054's enrollment target sits among peer trials

313 11th of 47 higher than 37 of 47 other Opioid-Related Disorders trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Opioid-Related Disorders 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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Related registry views

Source: ClinicalTrials.gov NCT01848054, the US trial registry maintained by the National Library of Medicine. NCT01848054 (mid enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.