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

Phase 3

Withdrawn

• Conditions: Other Acute Postoperative Pain; Prolonged Endotracheal Intubation
• Interventions: Drug: Buprenorphine IV

• Registration Number: NCT01324544
• Lead Sponsor: Purdue Pharma LP

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.

Study Timeline

• Study First Submitted: 2011-03-24
• Study First Submitted QC: 2011-03-28
• Study First Posted: 2011-03-29
• Study Start: 2011-11
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-03
• Last Update Posted: 2016-02-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Buprenorphine IV	Buprenorphine IV	Buprenorphine IV

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
The number of participants with adverse events as a measure of safety.	Up to 10 days