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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

Primary Purpose

About this trial

This is an interventional treatment trial for Other Acute Postoperative Pain focused on measuring Acute Pain, Opioid, Analgesia

Eligibility Criteria

undefined - 6 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Buprenorphine IV

Arm Description

Buprenorphine IV

Outcomes

Primary Outcome Measures

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 Measures

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

Full Information

NCT ID

NCT01324544

First Posted

March 24, 2011

Last Updated

February 3, 2016

Sponsor

Purdue Pharma LP

1. Study Identification

Unique Protocol Identification Number

NCT01324544

Brief Title

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

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Withdrawn

Why Stopped

Due to change in development plan.

Study Start Date

November 2011 (undefined)

Primary Completion Date

August 2014 (Anticipated)

Study Completion Date

August 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Purdue Pharma LP

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Other Acute Postoperative Pain, Prolonged Endotracheal Intubation

Keywords

Acute Pain, Opioid, Analgesia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Buprenorphine IV

Arm Type

Experimental

Arm Description

Buprenorphine IV

Intervention Type

Drug

Intervention Name(s)

Buprenorphine IV

Other Intervention Name(s)

Buprenex

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

Up to 24 hours

Secondary Outcome Measure Information:

Title

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

Time Frame

Up to 10 days

10. Eligibility

Sex

All

Maximum Age & Unit of Time

6 Years

Accepts Healthy Volunteers

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.

12. IPD Sharing Statement

Links:

URL

http://app.purduepharma.com/xmlpublishing/pi.aspx?id=b

Description

Product Information

Learn more about this trial

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

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