Status:
COMPLETED
A 15-day Study to Assess the Safety and Clinical Utility of Duragesic (Fentanyl Transdermal Patch) in the Treatment of Children With Continuous Pain Requiring Narcotic Pain Relief Therapy
Lead Sponsor:
Janssen Pharmaceutica N.V., Belgium
Conditions:
Chronic Pain
Eligibility:
All Genders
2-12 years
Phase:
PHASE3
Brief Summary
The objective of this study is to assess the safety and clinical utility of Duragesic® 12.5 micrograms/hour (a transdermal patch delivering the narcotic pain-reliever fentanyl) in the treatment of ch...
Detailed Description
A new dosage strength of Duragesic® TTS patch was developed to deliver 12.5 micrograms of fentanyl per hour, which is considered to be equi-analgesic to a daily dose of 45 mg of morphine administered ...
Eligibility Criteria
Inclusion
- Pediatric (age 2-12) patients suffering from continuous pain of a well-documented cause
- currently requiring treatment of pain with a strong opioid and expected to continue to require treatment with a strong opioid for the next 7 days
- prior therapy for pain included a minor analgesic, weak opioid, or strong opioid equivalent to the pain relief of 45 mg morphine or less a day
Exclusion
- Patients with a history of allergy or hypersensitivity to fentanyl or morphine
- have active skin disease that precludes application of Duragesic® or which may affect the absorption of fentanyl
- have a life expectancy was less than 1 month
- have a clinical condition that in the investigator's judgment prevents participation in the study (e.g., clinically relevant liver dysfunction), plan to undergo a surgical procedure within 3 days of study entry, or are currently using protease inhibitors (HIV/AIDS treatment)
- have participated in any other drug trial relating to pain control within one month of study entry or currently participating in any other study or research project which would interfere with this trial
Key Trial Info
Start Date :
March 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2001
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT00271414
Start Date
March 1 1999
End Date
March 1 2001
Last Update
May 17 2011
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