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

NCT01324544 | Withdrawn Phase 3

• 2 other identifiers: BUP30302010-021955-14
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Other Acute Postoperative Pain; Prolonged Endotracheal Intubation

Keywords

Acute Pain; Opioid; Analgesia

Outcome Measures

Primary Outcomes (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.

  Up to 24 hours

Secondary Outcomes (1)

• The number of participants with adverse events as a measure of safety.

  Up to 10 days

Study Arms (1)

Buprenorphine IV

EXPERIMENTAL

Buprenorphine IV

Drug: Buprenorphine IV

Interventions

Buprenorphine IV DRUG

Buprenorphine IV administered via patient-controlled analgesia (PCA) pump for at least 24 hours and up to 72 hours.

Also known as: Buprenex

Buprenorphine IV

Eligibility Criteria

• Age: Up to 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Purdue Pharma LP: lead

MeSH Terms

Conditions

Acute Pain; Agnosia

Interventions

Buprenorphine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2011
• First Posted: March 29, 2011
• Study Start: November 1, 2011
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: February 4, 2016

Record last verified: 2016-02