CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 313 enrolled
Drug / intervention
Buprenorphine/naloxone sublingual tablets +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01848054
NCT01848054Phase 3Completed
CompareCT.gov

A Randomized, Blinded, Active-controlled Non-inferiority Study of the Efficacy and Safety of OX219 for the Induction of Treatment of Opioid Dependence

Orexo AB·interventional·Posted May 7, 2013·Updated May 10, 2017

In Brief

A Phase 3 clinical trial evaluating Buprenorphine/naloxone sublingual tablets and Buprenorphine for Opioid-Related Disorders and Opiate Dependence. Completed, enrolled 313 participants across 14 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpioid-Related Disorders, Opiate Dependence
CountriesUnited States
CollaboratorsWorldwide Clinical Trials

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMay 7, 2013
Enrollment StartJun 1, 2013
Primary CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 13.2 years ago

Interventions

Buprenorphine/naloxone sublingual tabletsdrug

Advanced-formulation buprenorphine/naloxone sublingual tablets

Buprenorphinedrug

Buprenorphine sublingual tablets