Status:
COMPLETED
A Study to Assess the Safety, Dose Conversion, and Dose Individualization of Duragesic® (Fentanyl Transdermal Patch) in the Treatment of Children With Chronic Pain Requiring Narcotic Pain Relief Therapy
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Chronic Pain
Eligibility:
All Genders
2-15 years
Phase:
PHASE3
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/ho...
Detailed Description
This is a single-arm, nonrandomized, open-label, multicenter trial designed to enroll a total of approximately 200 pediatric subjects with moderate to severe chronic pain due to malignant or nonmalign...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2002
Estimated Enrollment :
199 Patients enrolled
Trial Details
Trial ID
NCT00271466
Start Date
February 1 2000
End Date
April 1 2002
Last Update
May 18 2011
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