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

This study has been withdrawn prior to enrollment.
(Due to change in development plan.)
Sponsor:
Information provided by (Responsible Party):
Purdue Pharma LP
ClinicalTrials.gov Identifier:
NCT01324544
First received: March 24, 2011
Last updated: November 17, 2011
Last verified: November 2011
  Purpose

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


Condition Intervention Phase
Other Acute Postoperative Pain
Prolonged Endotracheal Intubation
Drug: Buprenorphine IV
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Purdue Pharma LP:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

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

Enrollment: 0
Study Start Date: November 2011
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   up to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
No Contacts or Locations Provided
  More Information

Additional Information:
No publications provided

Responsible Party: Purdue Pharma LP
ClinicalTrials.gov Identifier: NCT01324544     History of Changes
Other Study ID Numbers: BUP3030, 2010-021955-14
Study First Received: March 24, 2011
Last Updated: November 17, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Purdue Pharma LP:
Acute Pain
Opioid
Analgesia

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Buprenorphine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotic Antagonists
Narcotics

ClinicalTrials.gov processed this record on April 16, 2014