Clinical trial NCT01324544: Pharmacokinetics, Safety, and Efficacy of Intravenous Dosing of Buprenorphine in Pediatric Patients Who Require Opioid Analgesia for Acute Moderate to Severe Pain
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 type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Other Acute Postoperative Pain
Prolonged Endotracheal Intubation
Keywords: Acute Pain
Opioid
Analgesia
Lead sponsor: Purdue Pharma LP
Sponsor class: INDUSTRY
First posted: 2011-03-29
Enrollment: 0
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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 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.

Primary outcomes:
measure: The primary outcome measures are clearance (CL/F) and apparent central volume of distribution (Vc/F) estimated using standard population nonlinear mixed effects methodology.
timeFrame: Up to 24 hours
Secondary outcomes:
measure: The number of participants with adverse events as a measure of safety.
timeFrame: Up to 10 days
Other outcomes:
Locations:
Study officials:
References: