Who is sponsoring NCT01903005?

NCT01903005 is sponsored by Orexo AB.

What drugs are being tested in NCT01903005?

Interventions in NCT01903005: Higher bioavailability BNX sublingual tablets.

What condition does NCT01903005 study?

NCT01903005 studies Opioid Dependence, on Agonist Therapy.

Is NCT01903005 still recruiting?

NCT01903005 is currently completed. Last updated 28 September 2015.

Are results published for NCT01903005?

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

Last reviewed 2015-09-28 · How we verify

NCT01903005

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

A Multi-center, Open-Label, 24-Week, Follow-Up Study to Assess Safety, Efficacy, and Treatment Adherence For Maintenance Treatment of Opioid Dependence With OX219

Completed Phase 4 Results posted Last updated 28 September 2015

What this trial tests

Phase 4 trial testing Higher bioavailability BNX sublingual tablets in Opioid Dependence, on Agonist Therapy in 668 participants. Completed in 1 September 2014.

Timeline

1 July 2013

Primary endpoint
1 September 2014

1 September 2014

Quick facts

Lead sponsor	Orexo AB
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	668
Start date	1 July 2013
Primary completion	1 September 2014
Estimated completion	1 September 2014
Sites	28 locations across United States

Drugs / interventions tested

Higher bioavailability BNX sublingual tablets — full drug profile →

Conditions studied

Opioid Dependence, on Agonist Therapy — all drugs for Opioid Dependence, on Agonist Therapy →

Sponsor

Orexo AB — full company profile →

Who can join

Adults 18 to 65, any sex, with Opioid Dependence, on Agonist Therapy. 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.

Number of Patients Reporting Treatment-Emergent Adverse Events
Time frame: Day 1 through week 24
Number of patients reporting treatment-emergent adverse events during open-label, extension treatment with higher bioavailability BNX sublingual tablets
Number of Patients Reporting Treatment-Related, Treatment-Emergent Adverse Events
Time frame: Day 1 through week 24
Treatment-emergent adverse events considered related to treatment with the higher bioavailability BNX sublingual tablets
Number of Patients Reporting Treatment-Emergent Serious Adverse Events
Time frame: Day 1 throught week 24
Patients reporting treatment-emergent serious adverse events considered either related or not related to treatment with the higher bioavailability BNX sublingual tablets
Number of Patient Discontinuations Due to Treatment-Emergent Adverse Events
Time frame: Day 1 through week 24
Study discontinuations due to treatment-emergent adverse events that occurred during treatment with bioavailability BNX sublingual tablets

Sponsor's own description

The purpose of this study was to assess safety, efficacy, and treatment retention following extended treatment with OX219, a higher-bioavailability buprenorphine/naloxone (BNX) sublingual tablet formulation in opioid-dependent patients who completed 1 of 2 primary efficacy and safety studies of OX219.

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 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 NCT01903005 (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: 28 September 2015

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/NCT01903005.

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