17 completed, 3 withdrawn, 1 recruiting, 1 unknown. 13 Phase 3, 6 Phase 2, 1 Phase 1, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 13 | Completed 10, Withdrawn 3 |
| Phase 2 | 6 | Completed 6 |
| Phase 1 | 1 | Completed 1 |
| Phase 4 | 1 | Unknown 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| True Functional Restoration and Analgesia in Non-Radicular Low Back Pain Buprenorphine Buccal Film [Belbuca], Urine Drug Screening, actigraph - Back Pain Lower Back Chronic, Chronic Pain | Phase 4 | Unknown | Carolinas Pain Institute | 40 | 2022-08-03 | 2023-02-08 |
| Single Dose Crossover Study to Compare the Respiratory Drive After Administration of Belbuca, Oxycodone and Placebo. Belbuca 300 µg, Belbuca 600 µg, Belbuca 900 µg - Respiratory Depression | Phase 1 | Completed | BioDelivery Sciences International | 19 | 2019-07-23 | 2021-02-05 |
| Risk of Major Adverse Cardiovascular Events for Naldemedine & Other Medications for Opioid Induced Constipation Naldemedine, Lubiprostone, Naloxegol - Opioid-induced Constipation | Recruiting | BioDelivery Sciences International | 34532 | 2019-01-04 | 2026-09-30 | |
| Efficacy, Tolerability, and Safety of DFN-15 DFN-15 Active, DFN-15 Placebo - Migraine Headache | Phase 3 | Completed | BioDelivery Sciences International | 631 | 2016-12-01 | 2023-01-10 |
| Efficacy, Tolerability, and Safety Study of DFN-15 DFN-15 Active, DFN-15 Placebo - Migraine Headache | Phase 3 | Completed | BioDelivery Sciences International | 622 | 2016-12-01 | 2023-01-10 |
| The Efficacy and Safety of Clonidine Hydrochloride Topical Gel, vs Clonidine Hydrochloride Gel Comparator to Treat Painful Diabetic Neuropathy Clonidine Hydrochloride Topical Gel, 0.1%, Clonidine Hydrochloride Gel Comparator - Painful Diabetic Neuropathy, Diabetic Neuropathy | Phase 2 | Completed | BioDelivery Sciences International | 138 | 2015-12-01 | 2017-09-20 |
| A Safety Study of Clonidine Hydrochloride Topical Gel, 0.1% in the Treatment of Painful Diabetic Neuropathy clonidine hydrochloride topical gel, 0.1% - Painful Diabetic Neuropathy, Diabetes | Phase 2 | Completed | BioDelivery Sciences International | 197 | 2014-06-01 | 2017-09-19 |
| Study of Clonidine Hydrochloride Topical Gel, 0.1% in the Treatment of Pain Associated With Diabetic Neuropathy Clonidine Gel 0.1%, Placebo - Painful Diabetic Neuropathy, Diabetic Neuropathy | Phase 2 | Completed | BioDelivery Sciences International | 260 | 2014-03-01 | 2017-09-26 |
| Evaluation of the Tolerability of Switching Subjects on Chronic ATC Opioid Therapy to Buprenorphine HCl Buccal Film Buprenorphine, Placebo film, Oxycodone - Pain | Phase 2 | Completed | BioDelivery Sciences International | 39 | 2013-06-01 | 2017-02-27 |
| Long-term Open-Label Safety Study to Evaluate EN3409 EN3409 - Low Back Pain, Osteoarthritis | Phase 3 | Completed | BioDelivery Sciences International | 304 | 2012-12-01 | 2018-10-18 |
| Efficacy Study to Evaluate Buprenorphine HCl Buccal Film in Opioid-Experienced Subjects Buprenorphine, Placebo - Low Back Pain | Phase 3 | Completed | BioDelivery Sciences International | 815 | 2012-09-01 | 2017-02-27 |
| Efficacy Study to Evaluate Buprenorphine HCl Buccal Film in Opioid-Naive Subjects Buprenorphine, Placebo - Low Back Pain | Phase 3 | Completed | BioDelivery Sciences International | 752 | 2012-08-01 | 2017-02-27 |
| An Open Label Study To Assess The Safety And Tolerability Of BEMA® Buprenorphine NX In Opioid Dependent Subjects BEMA Buprenorphine NX films - Opioid Dependence | Phase 2 | Completed | BioDelivery Sciences International | 249 | 2012-08-01 | 2017-04-04 |
| Longterm Safety Study of BEMA Buprenorphine in Subjects With Chronic Low Back Pain BEMA Buprenorphine - Pain, Low Back Pain | Phase 3 | Withdrawn | BioDelivery Sciences International | 2012-07-01 | 2012-04-17 | |
| Longterm Safety Study of BEMA Buprenorphine in Subjects With Chronic Pain BEMA Buprenorphine - Pain, Low Back Pain | Phase 3 | Completed | BioDelivery Sciences International | 302 | 2011-03-01 | 2018-08-07 |
| Efficacy and Safety Study of Buprenorphine HCl Buccal Film in Subjects With Low Back Pain Buprenorphine, Placebo - Pain, Low Back Pain | Phase 3 | Completed | BioDelivery Sciences International | 334 | 2010-11-01 | 2017-02-27 |
| Study of Buprenorphine HCl Buccal Film in the Treatment of Dental Pain Oxycodone, Buprenorphine, Placebo Film - Dental Pain | Phase 2 | Completed | BioDelivery Sciences International | 153 | 2009-08-01 | 2017-02-27 |
| Long-term Extension Study of BEMA™ Fentanyl BEMA Fentanyl - Respiratory Depression | Phase 3 | Completed | BioDelivery Sciences International | 5 | 2008-06-01 | 2019-09-24 |
| Study of BEMA™ Fentanyl in the Treatment of Breakthrough Pain in Cancer Subjects BEMA™, Placebo - Pain, Cancer | Phase 3 | Completed | BioDelivery Sciences International | 152 | 2006-02-01 | 2019-11-18 |
| Study of the Safety of BEMA™ Fentanyl Use for Breakthrough Pain in Cancer Subjects on Chronic Opioid Therapy BEMA Fentanyl - Pain, Cancer | Phase 3 | Completed | BioDelivery Sciences International | 244 | 2006-02-01 | 2012-10-05 |
Showing 20 of 22. Sign in to see all of them.
Pain (10) · Chronic Pain (6) · Low Back Pain (6) · Back Pain (4) · Diabetes Mellitus (3) · Diabetic Neuropathies (3) · Opioid-Related Disorders (3) · Behavior, Addictive (2) · Migraine Disorders (2) · Neoplasms (2) · Neuralgia (2) · Osteoarthritis (2) · Respiratory Insufficiency (2) · Ataxia Telangiectasia (1) · Neuropathy, Painful (1)
Buprenorphine (8) · Oxycodone (3) · Buprenorphine, Naloxone Drug Combination (2) · Celecoxib (2) · Fentanyl (2) · Lubiprostone (1) · Morphine (1) · naldemedine (1) · naloxegol (1)
United States (21)
Andrew Finn, PharmD (6) · Aziz Shaibani, MD (3) · David Blum, MD (3) · Greg Sullivan, MD (1) · James G Sullivan, MD (1) · Lynn Webster (1) · M. Todd Kirby, PhD (1) · Stephen Lanes (1) · Todd Kirby, PhD (1)
PMID 25823919, PMID 32978722, PMID 34447267, PMID 35524938, PMID 35587172