At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 71 enrolled
Drug / intervention
fentanyldrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open Label Evaluation of the Safety and Clinical Utility of the Active, Separated System With Enhanced Controller (SSEC) Fentanyl 40 mcg for the Management of Acute Postoperative Pain in Pediatric Patients 12 to Less Than 18 Years of Age
In Brief
A Phase 3 clinical trial evaluating fentanyl for Pain, Postoperative. Completed, enrolled 71 participants across 10 sites.
Detailed Summary
The objective of this study is to evaluate the safety and clinical utility of the active, SSEC fentanyl 40 micrograms (mcg) for the management of acute, postoperative pain in pediatric participants.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain, Postoperative
CountriesUnited States
CollaboratorsIncline Therapeutics, Inc.
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 2015
Enrollment StartJun 2015
Primary CompletionSep 2016
TodayJul 2026
First PostedMar 23, 2015
Enrollment StartJun 29, 2015
Primary CompletionSep 12, 2016
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 11.3 years ago
Interventions
fentanyldrug
An opioid that has been administered parenterally as an anesthetic and analgesic for more than 20 years.