NCT00271466

Brief Summary

The objective of this study is to assess the safety of treatment with Duragesic® (a transdermal patch delivering the narcotic pain-reliever fentanyl) in doses of 12.5, 25, 50, 75 and 100 micrograms/hour in pediatric subjects requiring narcotic pain relief therapy. Particular attention is paid to appropriate dose conversion to Duragesic® therapy from the subject's current narcotic pain relief therapy, and to the parameters for increasing the Duragesic® dose to achieve analgesic effectiveness. Pharmacokinetics (fentanyl levels in the bloodstream during treatment) will also be assessed.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
199

participants targeted

Target at P25-P50 for phase_3 chronic-pain

Timeline
Completed

Started Feb 2000

Typical duration for phase_3 chronic-pain

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2000

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2002

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

December 30, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 2, 2006

Completed
Last Updated

May 18, 2011

Status Verified

April 1, 2010

First QC Date

December 30, 2005

Last Update Submit

May 17, 2011

Conditions

Chronic Pain

Keywords

opioidfentanylDuragesictransdermalchronic painmorphine

Outcome Measures

Primary Outcomes (1)

  • Incidence and severity of adverse events; Physical examination results and vital signs

Secondary Outcomes (1)

  • Parent's global assessment of pain control on Days 1 and 16; Pain level assessed once in the morning and in the evening; Pain level at the time rescue medication is given and one hour afterwards; Pharmacokinetics

Interventions

Duragesic® (fentanyl) Therapeutic Transdermal System (TTS)DRUG

Eligibility Criteria

Age2 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patients suffering from chronic pain of a well documented cause that requires continuous administration of opioids
  • Received opioids continuously for a minimum of 7 days prior to enrollment with a projected need for continuous opioids for at least the length of the primary treatment period (15 days)
  • Received the pain relief medication equivalent to at least 30 mg of oral morphine the day prior to enrollment
  • Available for careful monitoring during the first 72 hours following administration of Duragesic®
  • If female of child-bearing potential, must have a negative serum or urine pregnancy test within 1 week of enrollment

You may not qualify if:

  • Patients with skin disease that precludes application of Duragesic® or which may affect the absorption of fentanyl
  • Known sensitivity to fentanyl, other opioids, or adhesives
  • Have a life expectancy less than the length of the primary treatment period (15 days)
  • Have pain due to surgery, a clinically significant fever (i.e., above 38 C/100.4 F), a clinical condition that in the investigator's judgment prevents participation in the study (e.g., clinically significant liver or kidney dysfunction), or are currently being treated with ketoconazole, ritonavir or other disallowed concomitant therapy
  • Female patients who are pregnant or breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Finkel JC, Finley A, Greco C, Weisman SJ, Zeltzer L. Transdermal fentanyl in the management of children with chronic severe pain: results from an international study. Cancer. 2005 Dec 15;104(12):2847-57. doi: 10.1002/cncr.21497.

    PMID: 16284992RESULT

Related Links

MeSH Terms

Conditions

Chronic Pain

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial

    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 30, 2005

First Posted

January 2, 2006

Study Start

February 1, 2000

Study Completion

April 1, 2002

Last Updated

May 18, 2011

Record last verified: 2010-04