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

Other Acute Postoperative Pain Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01324544
• Other study ID #: BUP3030
• Secondary ID: 2010-021955-14
• Status: Withdrawn
• Phase: Phase 3
• First received: March 24, 2011
• Last updated: February 3, 2016
• Start date: November 2011
• Est. completion date: August 2014

Study information

• Verified date: February 2016
• Source: Purdue Pharma LP
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 6 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Other Acute Postoperative Pain
• Pain, Postoperative
• Prolonged Endotracheal Intubation

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Purdue Pharma LP

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	The number of participants with adverse events as a measure of safety.		Up to 10 days	Yes

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