Pharmacokinetics, Safety, and Efficacy of Intravenous Dosing of Buprenorphine in Pediatric Patients Who Require Opioid Analgesia for Acute Moderate to Severe Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01324544
Recruitment Status : Withdrawn (Due to change in development plan.)
First Posted : March 29, 2011
Last Update Posted : February 4, 2016
Information provided by (Responsible Party):
Purdue Pharma LP

Brief Summary:
The purpose of this study is to characterize the safety, pharmacokinetics (PK), and efficacy of intravenous (IV) buprenorphine in pediatric patients.

Condition or disease Intervention/treatment Phase
Other Acute Postoperative Pain Prolonged Endotracheal Intubation Drug: Buprenorphine IV Phase 3

Detailed Description:
A study of the PK, safety, and efficacy of IV buprenorphine in acute moderate to severe pain in male and female pediatric patients aged from birth to 6 years, inclusive, requiring continuous opioid analgesic treatment for at least 24 hours and up to 72 hours.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Inpatient, Open-label Study to Characterize the Pharmacokinetics, Safety, and Efficacy of Intravenous Dosing of Buprenorphine in Pediatric Patients Aged From Birth to 6 Years of Age (Inclusive) Who Require Opioid Analgesia for Acute Moderate to Severe Pain
Study Start Date : November 2011
Estimated Primary Completion Date : August 2014
Estimated Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Buprenorphine IV
Buprenorphine IV
Drug: Buprenorphine IV
Buprenorphine IV administered via patient-controlled analgesia (PCA) pump for at least 24 hours and up to 72 hours.
Other Name: Buprenex

Primary Outcome Measures :
  1. The primary outcome measures are clearance (CL/F) and apparent central volume of distribution (Vc/F) estimated using standard population nonlinear mixed effects methodology. [ Time Frame: Up to 24 hours ]

Secondary Outcome Measures :
  1. The number of participants with adverse events as a measure of safety. [ Time Frame: Up to 10 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria include:

  • Must have written informed consent provided by the parent or legal guardian and/or patient assent, when appropriate
  • Male and female children, from birth to aged 6 years, inclusive, with minimum weight of 2.5 kg
  • Have or are anticipated to have acute moderate to severe pain; requiring treatment with an intravenous (IV) opioid analgesic medication for at least 24 hours postoperatively or; due to prolonged endotracheal intubation requiring IV opioid analgesic treatment for at least 24 hours poststabilization
  • Must have stable vital signs
  • Must have stable respiratory status
  • Must be inpatient for the treatment period of the study

Exclusion Criteria include:

  • Have any known allergy or sensitivity to buprenorphine or other opioids (this criterion does not include patients who have experienced common opioid side effects [eg, nausea, constipation])
  • Have evidence of impaired renal function
  • Have hepatic impairment
  • Have history of seizures
  • Have a history of sleep apnea within the past year
  • Have structural heart disease or a pacemaker
  • Have clinically unstable cardiac disease
  • Have used any investigational medication/therapy within 30 days prior to the first dose of study drug
  • Are deemed to be unsuitable by the investigator for reason(s) not specifically stated in the exclusion criteria.

Other protocol-specific inclusion/exclusion criteria may apply.

Additional Information:
Responsible Party: Purdue Pharma LP Identifier: NCT01324544     History of Changes
Other Study ID Numbers: BUP3030
2010-021955-14 ( EudraCT Number )
First Posted: March 29, 2011    Key Record Dates
Last Update Posted: February 4, 2016
Last Verified: February 2016

Keywords provided by Purdue Pharma LP:
Acute Pain

Additional relevant MeSH terms:
Pain, Postoperative
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists