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NCT01713803
Evaluation of BEMA® Buprenorphine NX for Buprenorphine Induction of Opioid Dependent Subjects
Phase 3 trial testing Buprenorphine and naloxone in Opioid Dependence. Withdrawn.
1 May 2017
Quick facts
| Lead sponsor | BioDelivery Sciences International |
|---|---|
| Phase | Phase 3 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Primary completion | 1 May 2017 |
| Estimated completion | 1 May 2017 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Buprenorphine and naloxone — full drug profile →
Conditions studied
- Opioid Dependence — all drugs for Opioid Dependence →
Sponsor
BioDelivery Sciences International — full company profile →
Who can join
Adults 18 to 65, any sex, with Opioid Dependence. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a randomized, double blind, placebo controlled study in opioid dependent subjects. Subjects meeting entry criteria will be treated with multiple doses of B-BNX or B-Placebo, with non-responders rescued within 6 hours. Open treatment B-BNX will be administered as follow-up therapy. Clinical efficacy assessments include the clinical opioid withdrawal scale (COWS), subject-rated assessments, and a urine drug screen.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT01713803
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other BioDelivery Sciences International trials
Trials by the same sponsor.
- NCT03996694 — Single Dose Crossover Study to Compare the Respiratory Drive After Administration of Belbuca, Oxycodone and Placebo. · Phase 1 · completed
- NCT03720613 — Risk of Major Adverse Cardiovascular Events for Naldemedine & Other Medications for Opioid Induced Constipation · recruiting
- NCT02516436 — The Safety of Using Buprenorphine With Naloxone in a Buccal Film to Initiate Treatment of Opioid Dependent Subjects · Phase 3 · withdrawn
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01713803 (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 BioDelivery Sciences International
- Last refreshed: 4 May 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/NCT01713803.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing