MedTrace Logo

Safety Study of Flector Patch in Children With Minor Soft Tissue Injuries

NCT02132247 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2018-05-11

Study results available
· View outcomes & findings →

Summary

The primary purpose of this study is to determine whether Flector Patch is safe for use in children. The secondary purpose is to assess blood levels of diclofenac, the active ingredient in Flector Patch.

Conditions

  • Athletic Injuries

Interventions

DRUG

Diclofenac hydroxyethylpyrrolidine

Sponsors & Collaborators

  • IBSA Institut Biochimique SA

    lead INDUSTRY

Principal Investigators

  • Clarence Jones, Ph.D. · IBSA Institut Biochimique SA

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2016-10-31
Completion
2017-05-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT02132247 on ClinicalTrials.gov