A Study to Evaluate the Safety and Effectiveness of Fentanyl-TTS Compared to Weak Opioids in Patients With Moderate to Severe Chronic Cancer Pain Previously Treated With NSAIDS (Non-steroidal Anti-inflammatory Drugs).
|ClinicalTrials.gov Identifier: NCT00576017|
Recruitment Status : Completed
First Posted : December 18, 2007
Last Update Posted : May 19, 2011
|Condition or disease||Intervention/treatment||Phase|
|Pain||Drug: Fentanyl-TTS||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomised Study to Evaluate the Efficacy and Safety of Fentanyl-TTS Versus Weak Opioids in Patients With Moderate to Severe Chronic Cancer Pain Previously Treated With NSAIDs (Non-steroidal Anti-inflammatory Drugs).|
|Study Start Date :||October 2003|
|Study Completion Date :||March 2005|
- The primary endpoint was the control of pain during treatment. Pain was assessed by the visual analogue scale. Pain severity was assessed at each follow-up visit.
- The secondary endpoint was to assess the advantages of using fentanyl-TTS after the first step of the WHO analgesic ladder as compared to minor opioids.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00576017
|Study Director:||Janssen-Cilag S.A. (formerly Janssen Sp) Clinical Trial||Janssen-Cilag, S.A.|