Clinical Trial Results:
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
Summary
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EudraCT number |
2010-021955-14 |
Trial protocol |
HU |
Global completion date |
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Paediatric regulatory details
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Is the trial part of an agreed EMA paediatric investigation plan? |
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Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
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Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
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Results information
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Results version number |
v1(current) |
This version publication date |
14 Oct 2021
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First version publication date |
14 Oct 2021
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Other versions |
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Summary report(s) |
BUP3030 |
Note: The legislation allows summary attachments to be posted instead of the full dataset for this trial. Refer to Commission Guideline 2012/C 302/03
for further information.