Who is sponsoring NCT01848054?

NCT01848054 is sponsored by Orexo AB.

What drugs are being tested in NCT01848054?

Interventions in NCT01848054: Buprenorphine/naloxone sublingual tablets, Buprenorphine.

What condition does NCT01848054 study?

NCT01848054 studies Opioid-Related Disorders, Opiate Dependence.

Is NCT01848054 still recruiting?

NCT01848054 is currently completed. Last updated 3 April 2017.

Are results published for NCT01848054?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2017-04-03 · How we verify

NCT01848054

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 3 Results posted Last updated 3 April 2017

What this trial tests

Phase 3 trial testing Buprenorphine/naloxone sublingual tablets in Opioid-Related Disorders in 313 participants. Completed in 1 January 2014.

Timeline

1 June 2013

Primary endpoint
1 January 2014

1 January 2014

Quick facts

Lead sponsor	Orexo AB
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	313
Start date	1 June 2013
Primary completion	1 January 2014
Estimated completion	1 January 2014
Sites	14 locations across United States

Drugs / interventions tested

Buprenorphine/naloxone sublingual tablets — full drug profile →
Buprenorphine (BUPRENORPHINE) — full drug profile →

Conditions studied

Opioid-Related Disorders — all drugs for Opioid-Related Disorders →
Opiate Dependence — all drugs for Opiate Dependence →

Sponsor

Orexo AB — full company profile →

Who can join

Adults 18 to 65, any sex, with Opioid-Related Disorders or Opiate Dependence. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Retention in Treatment in the Per Protocol Population
Time frame: Day 3
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 buprenorph

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Opioid-Related Disorders

Currently open trials in the same condition.

NCT06810076 — Developing and Evaluating a Machine-Learning Opioid Overdose Prediction & Risk-Stratification Tool in Primary Care · NA · active not recruiting
NCT06454903 — Developing a Smartphone Application to Support Veteran Opioid Use Disorder Treatment · NA · recruiting
NCT06387290 — Optimizing Chronic Pain Care With Mindfulness and Chronic Pain Management Visits · Phase 3 · recruiting
NCT06023459 — Extended-release Buprenorphine Compared to Sublingual Buprenorphine in Rural Settings (RXR) · Phase 3 · active not recruiting
NCT06001749 — Psilocybin in Cancer Pain Study · Phase 2 · recruiting

Other Orexo AB trials

Trials by the same sponsor.

NCT04948307 — OXD01 in Combination With Sublingual Buprenorphine/Naloxone for Treatment of Opioid Use Disorder · NA · completed
NCT01315886 — Conversion From Fast Acting Oral Opioids to Abstral® · Phase 4 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01848054 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Orexo AB
Last refreshed: 3 April 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01848054.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing