Who is sponsoring ISTART?

ISTART is sponsored by Orexo AB.

What condition does ISTART study?

ISTART studies Opioid Dependence, on Agonist Therapy.

What drugs are being tested in ISTART?

Interventions: BNX sublingual tablets, BNX sublingual film, Buprenorphine.

Last reviewed 2017-04-03 · How we verify

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

NCT01908842 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	Orexo AB
Phase	Phase 3
Status	COMPLETED
Enrolment	759
Start date	2013-08
Completion	2014-04

Conditions

Opioid Dependence, on Agonist Therapy

Interventions

BNX sublingual tablets
BNX sublingual film
Buprenorphine

Primary outcomes

Primary Endpoints of Retention in Treatment at Days 3 and 15 — Day 3 and Day 15
Retention rates (number of patients retained) for the primary efficacy endpoints of retention in treatment at Days 3 and 15, which was defined as the number of patients who received treatment on Days 3 and 15.

Countries

United States