Skip to content

A Study to Assess the Safety and Effectiveness of Durogesic (Fentanyl Transdermal Patch) in the Treatment of Children With Chronic Pain Requiring Long-term Narcotic Pain Relief Therapy

CompletedPhase 3NCT00271453
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

The purpose of this study is to assess the effectiveness and safety of Durogesic® (a transdermal patch delivering the narcotic pain-reliever fentanyl) in the treatment of children with chronic pain requiring long-term narcotic pain relief therapy.

Study details

Official title
A Study to Assess the Safety, Efficacy and Pharmacokinetics of Durogesic (Fentanyl Transdermal Drug Delivery System) in the Treatment of Pediatric Patients With Chronic Pain Requiring Long-term Opioid Therapy
Conditions
Interventions
  • Drug: Durogesic® (fentanyl transdermal drug delivery system)
Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Start date
1996-02
Sex
All
Age range
from 2 Years to 18 Years
Results posted
No results posted in this snapshot
Total sites listed
0

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Patients with a confirmed malignancy (whose pain is judged by the investigator to be caused by the malignancy), or patients with other life-threatening/terminal disease whose pain requires treatment with strong opioid analgesia * requiring treatment of pain with a strong opioid and who are expected to continue to require treatment with a strong opioid for the duration of the study * receiving a stable dose of immediate-release oral morphine or sustained-release morphine (minimum daily dose of morphine is 30 mg/day) for at least 48 hours immediately prior to entry into the study Exclusion Criteria: * Patients with a history of allergy or hypersensitivity to fentanyl or morphine * have active skin disease that precludes application of Durogesic® or which may affect the absorption of fentanyl * have a clinical condition that in the investigator's judgment prevents participation in the study * have participated in any other drug trial relating to pain control within one month of study entry * currently participating in any other study or research project which would interfere with this trial.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00271453