CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 759 enrolled
Drug / intervention
BNX sublingual tablets +2 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/NCT01908842
NCT01908842Phase 3Completed
CompareCT.gov

Induction, STabilization, Adherence, and Retention Trial (ISTART) - A Randomized, Non-inferiority, Multicenter Study to Assess Early Treatment Efficacy of OX219 Versus SUBOXONE Film and to Explore Switching Between Treatments

Orexo AB·interventional·Posted Jul 26, 2013·Updated May 10, 2017

In Brief

A Phase 3 clinical trial evaluating BNX sublingual tablets, BNX sublingual film, and 1 other intervention for Opioid Dependence, on Agonist Therapy. Completed, enrolled 759 participants across 36 sites.

Detailed Summary

The purpose of this study was to assess retention in treatment after induction with buprenorphine/naloxone (BNX) sublingual tablets compared with generic buprenorphine and after stabilization with BNX sublingual tablets compared with BNX film. Secondary objectives included assessment of treatment effects on opioid withdrawal symptoms, opioid cravings, and safety.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpioid Dependence, on Agonist Therapy
CountriesUnited States
CollaboratorsWorldwide Clinical Trials

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 26, 2013
Enrollment StartAug 1, 2013
Primary CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 12.9 years ago

Interventions

BNX sublingual tabletsdrug

Buprenorphine/naloxone sublingual tablets

BNX sublingual filmdrug

Buprenorphine/naloxone sublingual film

Buprenorphinedrug

Buprenorphine sublingual tablets