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

• Status: Withdrawn
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Purdue Pharma LP
• Treatments: Analgesics, Opioid; Buprenorphine

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.