Status:
COMPLETED
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
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Chronic Pain
Eligibility:
All Genders
2-18 years
Phase:
PHASE3
Brief Summary
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 r...
Detailed Description
The objective of this study is to establish the analgesic efficacy, safety and pharmacokinetic profile of Durogesic® in the treatment of pediatric patients with chronic pain requiring long-term opioid...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 1996
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 1998
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00271453
Start Date
February 1 1996
End Date
October 1 1998
Last Update
May 18 2011
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