A Study to Evaluate the Safety of D-TRANS Fentanyl With Naltrexone in Adult Patients With Chronic Pain and Who Are Opioid Tolerant
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00650182|
Recruitment Status : Completed
First Posted : April 1, 2008
Last Update Posted : May 19, 2011
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain||Drug: fentanyl; naltrexone||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||406 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Safety Evaluation of D-TRANS Fentanyl With Naltrexone HCL in Opioid Tolerant Patients (ALZA C-2002-022)|
|Study Start Date :||January 2003|
|Study Completion Date :||July 2003|
- To assess the safety of 2 transdermal formulations of fentanyl (D-TRANS fentanyl with naltrexone transdermal system and Duragesic (fentanyl transdermal system) in patients with chronic pain who were opioid tolerant.
- Efficacy assessments included patient global assessments, investigator global assessments, pain intensity, and brief pain inventory. Blood samples were also to be collected for analysis of naltrexone and fentanyl prior to any dose change.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00650182
|Study Director:||Alza Corporation Clinical Trial||ALZA|