CompletedInterventionalPhase 3Last updated May 17, 2011

A 15-day Study to Assess the Safety and Clinical Utility of Duragesic (Fentanyl Transdermal Patch) in the Treatment of Children With Continuous Pain Requiring Narcotic Pain Relief Therapy

A 15-day Trial to Document the Safety, Clinical Utility and Pharmacokinetics of Duragesic (TTS Fentanyl) in the Treatment of Pediatric Subjects With Continuous Pain Requiring Opioid Therapy

Overview

ClinicalTrials.gov ID: NCT00271414
Lead Sponsor: Janssen Pharmaceutica N.V., BelgiumINDUSTRY
Brief Summary: The objective of this study is to assess the safety and clinical utility of DuragesicÂ® 12.5 micrograms/hour (a transdermal patch delivering the narcotic pain-reliever fentanyl) in the treatment of children ages 2 to 12 with continuous pain requiring narcotic pain relief therapy. Pharmacokinetics (fentanyl levels in the bloodstream during treatment) will also be assessed.
Study Type

Status

Overall Status: Completed
Start Date: Mar 1999
Primary Completion Date: No data available
Completion Date: Mar 2001Actual

Study Record Dates

First Submitted: Dec 30, 2005
First Submitted that Met QC Criteria: Dec 30, 2005
First Posted: Jan 2, 2006Estimated
Last Update Submitted that Met QC Criteria: May 16, 2011
Last Update Posted: May 17, 2011Estimated
Last Verified: Apr 2010

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