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Withdrawn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.
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.
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