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
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 |
The purpose of this study is to characterize the safety, pharmacokinetics (PK), and efficacy of intravenous (IV) buprenorphine in pediatric patients.
Status | Withdrawn |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. |
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Purdue Pharma LP |
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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