Overview

A Study of the Effect on Pain Control of Treatment With Fentanyl, Administered Through the Skin, Compared With Placebo in Patients With Osteoarthritis

Status:
Completed
Trial end date:
2004-04-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of the study is to determine if fentanyl, delivered through the skin via an adhesive patch, has a superior pain-relieving effect compared with placebo in patients with osteoarthritis pain that is inadequately controlled by therapeutic treatment with weak opioids, which are often taken in combination with non-opioid analgesics.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Janssen Pharmaceutica N.V., Belgium
Treatments:
Fentanyl
Criteria
Inclusion Criteria:

- Patients with osteoarthritis (OA) of the hip or the knee (as defined by the American
College of Rheumatology) and radiological evidence of OA from the target joint

- patients must be in need of and waiting for hip or knee replacement

- patients with chronic pain for longer than 3 months for >=20 days/month

- patients with moderate to severe OA pain of the target joint (VAS score >=50 on a
scale of 0-100), whose pain was not adequately controlled with weak opioids, with or
without non-opioid pain medication

- women must be postmenopausal or using adequate contraception, have a negative
pregnancy test at study initiation, and not be breastfeeding.

Exclusion Criteria:

- Patients who had previously failed fentanyl therapy or had discontinued treatment due
to adverse events

- known allergy or hypersensitivity to fentanyl or to the adhesives

- patients being treated for depression or epilepsy

- patients who received sedative hypnotics, anaesthetics and/or muscle relaxants in the
week preceding the Run-In Period

- patients experiencing another type of continuous pain that stands out in comparison
with OA pain

- patients with major trauma to the target joints, infection in these joints, or
irreversible damage to these joints during the 6 months before the study.