Overview

An Efficacy and Safety Study of Transdermal Therapeutic System (TTS)-Fentanyl in Severe Chronic Low Back Pain

Status:
Completed

Trial end date:
2009-06-01

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 severe (very serious, life threatening) chronic (lasting a long time) low back pain in Thai participants.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Janssen-Cilag Ltd.,Thailand

Treatments:

Fentanyl

Criteria

Inclusion Criteria: -Chronic low back pain with moderate to severe pain at least 3 months
-Participants needed to be treated with strong opioid and haven't been treated with strong
opioid in the past -Participants who still had moderate to severe pain (Visual Analog Scale
[VAS] >= 4), which was not adequately controlled by weak opioids such as tramadol or
codeine at optimal doses (at least 120 milligram [mg] per day for tramadol or 200 mg per
day for codeine) for at least 7 consecutive days

-Participants who failed from other treatments such as operation or lack of efficacy of
current treatment -Participant who has signed the informed consent form Exclusion Criteria:
-Skin disease that prevent 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 cardiac, nervous system or respiratory disease which in
the investigator's judgment precludes participation in the study because of the potential
for respiratory depression -Concomitant use of Non Steroidal Anti-Inflammatory Drugs
(NSAIDs), Cyclooxygenase - 2 (COX-2), muscle relaxant, topical analgesic during the
previous week (unless on stable drug dose for at least 1 month before study entry)
-Pregnancy or breast-feeding female; female participants of childbearing potential without
adequate contraception