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Sponsored by: |
Janssen Pharmaceutica N.V., Belgium |
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Information provided by: | Janssen Pharmaceutica N.V., Belgium |
ClinicalTrials.gov Identifier: | NCT00271414 |
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 children ages 2 to 12 with continuous pain requiring narcotic pain relief therapy. Pharmacokinetics (fentanyl levels in the bloodstream during treatment) will also be assessed.
Condition | Intervention | Phase |
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Chronic Pain |
Drug: Duragesic® (fentanyl) Transdermal Therapeutic System (TTS) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study |
Official Title: | A 15-Day Trial to Document the Safety, Clinical Utility and Pharmacokinetics of Duragesic® ¿ (TTS Fentanyl) in the Treatment of Pediatric Subjects With Continuous Pain Requiring Opioid Therapy |
Estimated Enrollment: | 53 |
Study Start Date: | March 1999 |
Study Completion Date: | March 2001 |
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 orally, and considered a safe starting dose in children aged 2 to 12 years. This is a single-arm, non-randomized, open-label, 15-day multicenter trial to determine the safety, clinical utility, and pharmacokinetics of Duragesic® in pediatric subjects who require treatment with a potent opioid for the management of continuous pain, allowing individual titration. After the 15-day primary treatment period, subjects may, at the investigator's discretion, continue long-term treatment with Duragesic® for a period of up to 1 year. All subjects start treatment with a 12.5 micrograms/hour patch. Immediate-release morphine is available to treat breakthrough pain. The patches are replaced every 72 hours. The objective is to have subjects pain-free as much as possible, using the least possible rescue medication. Duragesic® dose increases are considered based on rescue medication consumption and pain assessment. Where a subject is maintained pain-free with a daily consumption of 45 mg of rescue morphine or more, a dose increase of Duragesic® with 12.5 micrograms/hour is permitted. No increase in Duragesic® dose is to be performed within the 72-hour dosing interval. The primary outcome of this study is an assessment of safety, including the incidence and severity of adverse events, and physical examination results and vital signs. Clinical utility is assessed by the parent's treatment assessment of pain relief, tolerability and convenience (pre-treatment and after each patch change); the investigator's and the parent's global assessments on Day 16 of pain control, adverse events, and convenience; daily measures of pain levels; use of rescue medication; and the child's play performance. Pharmacokinetics will also be assessed.
Duragesic® will be applied to the upper torso, and replaced every 72 hours. The initial dose is one patch with a fentanyl delivery rate of approximately 12.5 micrograms/hour. Dose increases in steps of 12.5 micrograms/hour are considered if pain is inadequately controlled. The treatment phase is 15 days.
Ages Eligible for Study: | 2 Years to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | CR005962 |
Study First Received: | December 30, 2005 |
Last Updated: | January 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00271414 |
Health Authority: | Belgium: Ministry of Social Affairs, Public Health and the Environment; United States: Food and Drug Administration |
fentanyl opioid chronic pain |
morphine Duragesic transdermal |
Morphine Fentanyl Pain |
Anesthetics, Intravenous Physiological Effects of Drugs Central Nervous System Depressants Anesthetics Narcotics Pharmacologic Actions Adjuvants, Anesthesia |
Sensory System Agents Anesthetics, General Therapeutic Uses Analgesics Peripheral Nervous System Agents Central Nervous System Agents Analgesics, Opioid |