Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-24 @ 4:44 PM
NCT ID:
NCT00271466
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
15 Years
Study:
NCT00271466
Study Brief:
Protocol Section:
NCT00271466