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
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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