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Fish and Richardson
Citi
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UBS
Farmers Insurance
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Fuji
Chubb
Moodys

Generated: February 18, 2019

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CLINICAL TRIALS PROFILE FOR BUPRENEX

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Clinical Trials for Buprenex

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Dosing of Buprenorphine in Pediatric Patients Who Require Opioid Analgesia for Acute Moderate to Severe Pain Withdrawn Purdue Pharma LP Phase 3 The purpose of this study is to characterize the safety, pharmacokinetics (PK), and efficacy of intravenous (IV) buprenorphine in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

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Clinical Trial Conditions for Buprenex

Condition Name

Condition Name for Buprenex
Intervention Trials
Depression 2
Neonatal Abstinence Syndrome 2
Fetus and Newborn Affected by Other Maternal Medication 1
Withdrawal 1
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Condition MeSH

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

Trials by Country

Trials by Country for Buprenex
Location Trials
United States 6
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Trials by US State

Trials by US State for Buprenex
Location Trials
Pennsylvania 4
Florida 1
Connecticut 1
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Clinical Trial Progress for Buprenex

Clinical Trial Phase

Clinical Trial Phase for Buprenex
Clinical Trial Phase Trials
Phase 3 4
Phase 1/Phase 2 2
Phase 1 1
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Clinical Trial Status

Clinical Trial Status for Buprenex
Clinical Trial Phase Trials
Completed 3
Recruiting 2
Withdrawn 1
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Clinical Trial Sponsors for Buprenex

Sponsor Name

Sponsor Name for Buprenex
Sponsor Trials
Thomas Jefferson University 2
National Institute of Mental Health (NIMH) 1
Gauda, Estelle B., M.D. 1
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Sponsor Type

Sponsor Type for Buprenex
Sponsor Trials
Other 9
NIH 2
Industry 1
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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Fish and Richardson
McKesson
Julphar
US Army
Baxter
QuintilesIMS
Argus Health
UBS

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