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Safety and Clinical Utility Study of SSEC Fentanyl 40 mcg for Acute Post-op Pain Management in Pediatric Participants

NCT02395653 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2017-10-26

Study results available
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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.

Conditions

  • Pain, Postoperative

Interventions

DRUG

fentanyl

An opioid that has been administered parenterally as an anesthetic and analgesic for more than 20 years.

Sponsors & Collaborators

  • Incline Therapeutics, Inc.

    collaborator INDUSTRY

  • The Medicines Company

    lead INDUSTRY

Principal Investigators

  • Elliot J Krane, MD · Stanford Children's Health

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-29
Primary Completion
2016-09-12
Completion
2016-09-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02395653 on ClinicalTrials.gov