Status:
COMPLETED
Efficacy and Safety Study of Fentanyl Transdermal Patch for Treatment of Chronic Pain
Lead Sponsor:
Janssen Korea, Ltd., Korea
Conditions:
Chronic Pain
Eligibility:
All Genders
19+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to confirm effectiveness and safety of fentanyl transdermal patch Durogesic® D-Trans for treatment of chronic pain in participants with chronic non-cancer pain.
Detailed Description
This trial is a Phase 4, prospective, open-label (meaning that both the research physician and study participants will know which medication is being administered) study of fentanyl transdermal patch-...
Eligibility Criteria
Inclusion
- spine related and extremity pain lasting for 3 months or longer
- pain with Numeric Rating Scale (NRS) at 4 or higher in the past 72 hours
- good overall health condition based on the medical history and clinical laboratory tests
- participants using appropriate contraception in case of childbearing potential during the study period.
Exclusion
- history of hypersensitive reaction to narcotic analgesics
- history of narcotic abuse
- serious psychotic disorder
- unable to use transdermal analgesics due to a dermatological condition
- history of CO2 retention (e.g., chronic obstructive pulmonary disease)
- surgery in the area with pain within 7 days prior to initiation of the clinical study.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT01902524
Start Date
October 1 2005
End Date
November 1 2006
Last Update
August 28 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Asan Medical Center
Seoul, South Korea, 140-702