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
CompletedPhase 3NCT00271414
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- 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
- Conditions
- Interventions
- Drug: Duragesic® (fentanyl) Transdermal Therapeutic System (TTS)
- Sponsor
- Janssen Pharmaceutica N.V., Belgium
- Start date
- 1999-03
- Sex
- All
- Age range
- from 2 Years to 12 Years
- Results posted
- No results posted in this snapshot
- Total sites listed
- 0
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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 Criteria: * 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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00271414