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CLINICAL TRIALS PROFILE FOR BUPRENEX

Clinical Trials for Buprenex

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Trial ID	Title	Status	Sponsor	Phase	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Dosing of Buprenorphine in Pediatric Patients Who Require Opioid Analgesia for Acute Moderate to Severe Pain	Withdrawn	Purdue Pharma LP	Phase 3	The purpose of this study is to characterize the safety, pharmacokinetics (PK), and efficacy of intravenous (IV) buprenorphine in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	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	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	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	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.
NCT01671410	Buprenorphine for Treatment of Neonatal Abstinence Syndrome in Infants With In Utero Exposure to Benzodiazepines	Completed	Thomas Jefferson University	Phase 1	The opioid neonatal abstinence syndrome (NAS) is a condition of withdrawal symptoms after utero exposure to opioids. Sublingual buprenorphine shows promise as a new treatment in NAS. This trial will investigate the safety and tolerability of sublingual buprenorphine in infants exposed to both opioids and benzodiazepines in utero or with exposure of opioids in those who are breastfeeding.
NCT02176291	Incomplete Response in Late-Life Depression: Getting to Remission With Buprenorphine	Active, not recruiting	National Institute of Mental Health (NIMH)	Phase 3	The purposes of this project are to examine the feasibility, safety, tolerability and clinical effect of low-dose buprenorphine as a novel treatment for late-life treatment-resistant depression and to develop preliminary data about mechanism of action.
Trial ID	Title	Status	Sponsor	Phase	Summary