Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00269737
Status:
COMPLETED
Last Update Posted:
2011-05-19
First Post:
2005-12-22
Brief Title:
Efficacy of the Fentanyl Transdermal Therapeutic System TTS in the Management of Pain in Patients With Cancer
Sponsor:
Alza Corporation DE USA
Organization:
Alza Corporation DE USA
Study Overview
Official Title:
Efficacy of TTS Fentanyl in the Management of Pain in Patients With Malignancy - Study III
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the safety and effectiveness of continuous use of TTS fentanyl a transdermal patch delivering the narcotic pain reliever fentanyl for the treatment of chronic cancer pain
Detailed Description:
Moderate to severe pain is experienced by about one-third of cancer patients during the intermediate stage of their disease Currently used medications for the treatment of moderate to severe pain due to cancer often provide inadequate pain relief and require repeated oral administration of a narcotic Providing prolonged safe and effective pain relief on a continuous basis would be a major therapeutic advance in the management of cancer pain This is an open-label pilot study to evaluate the safety and effectiveness of the fentanyl Transdermal Therapeutic System TTS in the management of chronic pain in patients with cancer The initial dose of the fentanyl transdermal patch is calculated based upon the equi-analgesic potency ratio of the narcotic used prior to study entry Four dosage strengths of the fentanyl transdermal patch are available as study medication with a nominal delivery rate of 100 75 50 and 25 micrograms of fentanyl per hour Multiple transdermal patches are worn when higher doses are required Morphine sulfate is available as needed as rescue medication to treat breakthrough pain After the initial application the dose is titrated for each patient within a hospital setting over the course of 3 days or as long as is necessary to achieve adequate pain control Changes in dose during titration occur no more frequently than once every 24 hours After an appropriate dose is reached the transdermal patch is replaced every 72 hours with a new transdermal patch applied to a fresh skin site When discharged patients enter a 3-week program of twice weekly nursing visits to monitor patient progress Patients are evaluated at designated time intervals for pain intensity vital signs and serum fentanyl concentration Records are kept of all concomitant medications administered during the study and any adverse events After completion of the 3-week program patients are given the opportunity to remain on the fentanyl Transdermal Therapeutic System TTS for long-term treatment of their chronic pain
The TTS fentanyl transdermal patch starting dose is calculated based upon the equi-analgesic potency ratio of the narcotic used prior to study entry titrated as needed to achieve adequate pain control The patch is replaced every 72 hours The treatment phase is 3 weeks
The TTS fentanyl transdermal patch starting dose is calculated based upon the equi-analgesic potency ratio of the narcotic used prior to study entry titrated as needed to achieve adequate pain control The patch is replaced every 72 hours The treatment phase is 3 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None