Overview

An Efficacy and Safety Study of Transdermal Therapeutic System (TTS)-Fentanyl in Participants With Osteoarthritis

Status:
Completed

Trial end date:
2009-04-01

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 participants with moderate (medium level of seriousness) to severe (very serious, life threatening) pain of osteoarthritis (disorder, which is seen mostly in older persons, in which the joints become painful and stiff).

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Janssen-Cilag Ltd.,Thailand

Treatments:

Fentanyl

Criteria

Inclusion Criteria:

- Chronic (lasting a long time) primary osteoarthritis pain for more than 3 months with
Visual Analog Scale (VAS) greater than or equal to 5

- Participants having moderate to severe pain (VAS greater than or equal to 5), which
was not adequately controlled by weak opioids such as tramadol or codeine at optimal
doses (at least 150 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

Exclusion Criteria:

- Skin disease that prevents 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

- Confusion, reduced level of consciousness, or concomitant (given at the same time)
psychiatric disorder which, in the opinion of the investigator, could prevent
participation in the trial

- Pregnant or breast-feeding female; female participants of child bearing potential
without adequate contraception