Status:
COMPLETED
A Study to Evaluate the Safety of D-TRANS Fentanyl With Naltrexone in Adult Patients With Chronic Pain and Who Are Opioid Tolerant
Lead Sponsor:
Alza Corporation, DE, USA
Conditions:
Chronic Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The primary objective was to evaluate the safety of D-TRANS fentanyl with naltrexone HCl system compared to the Duragesic (fentanyl transdermal system) in opioid tolerant patients.
Detailed Description
This was a multicenter, randomized, double-blind, double-dummy safety study in adult patients who required continuous opioid treatment for chronic pain. Patients had to be on a stable dose of duragesi...
Eligibility Criteria
Inclusion
- Diagnosis of chronic pain who require continuous opioid analgesia
- Must enter the study on a stable dose of Duragesic for at least 21 days and consent to use a medically acceptable method of contraception throughout the entire study, and for females 1 week after the study is completed and for males 3 months after the study is completed.
Exclusion
- Skin disease that precluded the use of a transdermal system
- Clinically significant laboratory abnormalities
- Significant mental status changes that result in disorientation, memory impairment, or inability to report accurately
- Illicit drug, prescription drug, or alcohol abuse
- Cardiopulmonary disease
- Pregnant or breastfeeding.
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2003
Estimated Enrollment :
406 Patients enrolled
Trial Details
Trial ID
NCT00650182
Start Date
January 1 2003
End Date
July 1 2003
Last Update
May 19 2011
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.