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

• Status: Completed
• Trial end date: 1998-10-01
• Target enrollment: 0
• Participant gender: All

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 requiring long-term narcotic pain relief therapy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Fentanyl

Criteria

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.