Status:
COMPLETED
An Efficacy and Safety Study of Transdermal Therapeutic System (TTS)-Fentanyl in Thai Participants With Chronic Non-Malignant Pain
Lead Sponsor:
Janssen-Cilag Ltd.,Thailand
Conditions:
Chronic Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Transdermal Therapeutic System (TTS)-fentanyl patch (transdermal patch containing a drug that is put on the skin so the drug will en...
Detailed Description
This is an open label (all people know the identity of the intervention), single arm study to assess the efficacy and safety of TTS-fentanyl in Thai participants with chronic non-malignant pain (excep...
Eligibility Criteria
Inclusion
- Participants with chronic non-malignant pain (of any etiology except for headaches or central spinal cord mediated pain) with moderate (medium level of seriousness) to severe (very serious, life threatening) pain that requires treatment with a potent opioid
- Participants must also be currently treated with short or long acting opioid medications other than Transdermal Therapeutic System (TTS)-fentanyl at a dose less than or equal to 134 milligram per day (mg/day) of oral morphine (or an equianalgesic dose of another opioid), participants may have been treated with TTS-fentanyl in the past
- Participants who had side effects after receiving Non Steroidal Anti-inflammatory Drugs (NSAIDs)
- Participants who failed from other treatments such as operation or lack of efficacy of current treatment
- Participants with spinal cord stimulators may enroll, provided that they turn the spinal cord stimulator off for the duration of the trial, or leave it continually on for the duration of the trial
Exclusion
- History of allergy, hypersensitivity, or lack of ability to tolerate fentanyl
- Skin disease that precludes the use of the transdermal system or which could affect the absorption of fentanyl or local tolerability
- History or suspicion of alcohol or drug abuse within the past 5 years
- History of narcotic (strong habit-forming drug that stops pain and depresses the central nervous system) therapy
- Pregnancy or breast-feeding female
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT01816243
Start Date
April 1 2004
End Date
March 1 2008
Last Update
April 28 2014
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Anesthesia, Faculty of Medicine, Siriraj Hospital, Mahidol University
Bangkok, Thailand
2
Bangkok, Thailand