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An Evaluation of Safety of the Fentanyl Transdermal System for Management of Acute Post-Operative Pain in Pediatric Patients

NCT00666393 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2014-03-03

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and clinical utility of fentanyl HCl 40 mcg system for the management of postoperative pain in pediatric inpatients.

Conditions

  • Pain, Postoperative
  • Pediatrics

Interventions

DRUG

fentanyl iontophoretic transdermal system (40mcg) No placebo

40 mcg per dose, maximum of 6 doses/hour; total maximum 80 doses/24 hours

DRUG

fentanyl iontophoretic transdermal system (40mcg)

40 mcg per dose, maximum of 6 doses/hour; total maximum 80 doses/24 hours

Sponsors & Collaborators

  • Alza Corporation, DE, USA

    lead INDUSTRY

Principal Investigators

  • Alza Corporation Clinical Trial · ALZA

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2010-12-31
Completion
2010-12-31

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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 NCT00666393 on ClinicalTrials.gov