CLINICAL TRIALS PROFILE FOR BUPRENEX

All Clinical Trials for Buprenex

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01324544 ↗	Pharmacokinetics, Safety, and Efficacy of Intravenous Dosing of Buprenorphine in Pediatric Patients Who Require Opioid Analgesia for Acute Moderate to Severe Pain	Withdrawn	Purdue Pharma LP	Phase 3	2011-11-01	The purpose of this study is to characterize the safety, pharmacokinetics (PK), and efficacy of intravenous (IV) buprenorphine in pediatric patients.
NCT01407575 ↗	Buprenorphine for Treatment Resistant Depression	Completed	National Alliance for Research on Schizophrenia and Depression	Phase 3	2011-09-01	The purpose of this study is to compare the safety and efficacy of buprenorphine with placebo for adults with treatment resistant depression (TRD).
NCT01407575 ↗	Buprenorphine for Treatment Resistant Depression	Completed	University of Pittsburgh	Phase 3	2011-09-01	The purpose of this study is to compare the safety and efficacy of buprenorphine with placebo for adults with treatment resistant depression (TRD).
NCT01452789 ↗	Blinded Trial of Buprenorphine or Morphine in the Treatment of the Neonatal Abstinence Syndrome	Completed	National Institute on Drug Abuse (NIDA)	Phase 3	2011-11-01	The opioid neonatal abstinence syndrome (NAS) is a condition of withdrawal symptoms after utero exposure to opioids. In an open label Phase 1 trial sublingual buprenorphine was associated with a ~30% reduction length of treatment compared to standard of care morphine. Due to the subjective nature of the scoring instrument, efficacy in a blinded trial is needed to unequivocally establish the superiority of buprenorphine over morphine. The primary objective of the trial is to compare length of treatment using sublingual buprenorphine or oral morphine solution in the pharmacologic treatment of the NAS.
NCT01452789 ↗	Blinded Trial of Buprenorphine or Morphine in the Treatment of the Neonatal Abstinence Syndrome	Completed	Thomas Jefferson University	Phase 3	2011-11-01	The opioid neonatal abstinence syndrome (NAS) is a condition of withdrawal symptoms after utero exposure to opioids. In an open label Phase 1 trial sublingual buprenorphine was associated with a ~30% reduction length of treatment compared to standard of care morphine. Due to the subjective nature of the scoring instrument, efficacy in a blinded trial is needed to unequivocally establish the superiority of buprenorphine over morphine. The primary objective of the trial is to compare length of treatment using sublingual buprenorphine or oral morphine solution in the pharmacologic treatment of the NAS.

Clinical Trial Conditions for Buprenex

Condition Name

Condition Name for Buprenex
Intervention	Trials
Neonatal Abstinence Syndrome	2
Depression	2
Depressive Disorder	1
Depressive Disorder, Major	1

Condition MeSH

Condition MeSH for Buprenex
Intervention	Trials
Neonatal Abstinence Syndrome	3
Depressive Disorder, Major	2
Depressive Disorder	2
Depression	2

Clinical Trial Locations for Buprenex

Trials by Country

Trials by Country for Buprenex
Location	Trials
United States	7

Trials by US State

Trials by US State for Buprenex
Location	Trials
Pennsylvania	4
Wisconsin	1
Florida	1
Connecticut	1

Clinical Trial Progress for Buprenex

Clinical Trial Phase

Clinical Trial Phase for Buprenex
Clinical Trial Phase	Trials
Phase 3	3
Phase 2	2
Phase 1/Phase 2	2

Clinical Trial Status

Clinical Trial Status for Buprenex
Clinical Trial Phase	Trials
Completed	4
Unknown status	1
Active, not recruiting	1

Clinical Trial Sponsors for Buprenex

Sponsor Name

Sponsor Name for Buprenex
Sponsor	Trials
Thomas Jefferson University	2
National Institute of Mental Health (NIMH)	1
Jordan F. Karp	1

Sponsor Type

Sponsor Type for Buprenex
Sponsor	Trials
Other	10
NIH	2
U.S. Fed	1