Pharmacokinetics, Safety, and Efficacy of Intravenous Dosing of Buprenorphine in Pediatric Patien… (NCT01324544) | Clinical Trial Compass
WithdrawnPhase 3
Pharmacokinetics, Safety, and Efficacy of Intravenous Dosing of Buprenorphine in Pediatric Patients Who Require Opioid Analgesia for Acute Moderate to Severe Pain
Stopped: Due to change in development plan.
0Started 2011-11
Plain-language summary
The purpose of this study is to characterize the safety, pharmacokinetics (PK), and efficacy of intravenous (IV) buprenorphine in pediatric patients.
Who can participate
Age range
6 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The primary outcome measures are clearance (CL/F) and apparent central volume of distribution (Vc/F) estimated using standard population nonlinear mixed effects methodology.