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

Information source: Purdue Pharma LP
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Other Acute Postoperative Pain; Prolonged Endotracheal Intubation

Intervention: Buprenorphine IV (Drug)

Phase: Phase 3

Status: Withdrawn

Sponsored by: Purdue Pharma LP

Summary

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

Clinical Details

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 design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The primary outcome measures are clearance (CL/F) and apparent central volume of distribution (Vc/F) estimated using standard population nonlinear mixed effects methodology.

Secondary outcome: The number of participants with adverse events as a measure of safety.

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

Minimum age: N/A. Maximum age: 6 Years. Gender(s): Both.

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.

Locations and Contacts

Additional Information

Product Information

Starting date: November 2011
Last updated: November 17, 2011

Page last updated: August 20, 2015

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