Overview

An Efficacy and Safety Study of Transdermal Therapeutic System (TTS)-Fentanyl in Thai Participants With Chronic Non-Malignant Pain

Status:
Completed
Trial end date:
2008-03-01
Target enrollment:
0
Participant gender:
All
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 enter the body through the skin) in Thai participants with chronic (lasting a long time) non-malignant (non-cancerous) pain.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Janssen-Cilag Ltd.,Thailand
Treatments:
Fentanyl
Morphine
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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