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Pharmacokinetics, Safety, and Efficacy of SPRIX in 12 to 17 Year Old Patients vs. Adult Patients Undergoing Open Surgical Procedures

NCT01819610 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2015-07-07

No results posted yet for this study

Summary

A SPRIX trial in pediatric subjects vs. adults undergoing open surgical procedures resulting in at least a moderate pain level. Subjects will receive SPRIX and blood samples will be collected for pharmacokinetic (PK) assessment. Subjects will also be assessed on the safety and efficacy of SPRIX.

Conditions

Interventions

DRUG

SPRIX

Sponsors & Collaborators

  • American Regent, Inc.

    lead INDUSTRY

Principal Investigators

  • David Bregman, M.D, Ph.D. · American Regent, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2014-03-31
Completion
2014-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT01819610 on ClinicalTrials.gov