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

NCT00236366 | Completed Phase 4

• 1 other identifier: CR003004
• Study Type: interventional
• Target: 418
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Osteoarthritis; Arthritis

Keywords

Fentanyl; opioid analgesics; osteoarthritis; arthritis; transdermal administration

Outcome Measures

Primary Outcomes (1)

• Average Area Under the Curve Minus Baseline (AAUCMB) of pain relief, as measured by Visual Analogue Scale (VAS) scores for daily pain during the treatment period (6 weeks)

Secondary Outcomes (1)

• SF-36 Quality of Life Questionnaire (QoL) and WOMAC questionnaire on Days 1 and 43 and at end of tapering-off period; adverse events throughout study

Interventions

fentanyl DRUG

Eligibility Criteria

• Age: 41 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Janssen Pharmaceutica N.V., Belgium: lead

Related Links

• Randomized, double-blind, placebo-controlled, parallel-group, multicentre trial to investigate DurogesicTM in subjects with moderate to severe pain induced by osteoarthritis of the hip or the knee.

MeSH Terms

Conditions

Osteoarthritis; Arthritis

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Janssen Pharmaceutica N.V. Clinical Trial

  Janssen Pharmaceutica N.V.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 7, 2005
• First Posted: October 12, 2005
• Study Start: June 1, 2002
• Study Completion: April 1, 2004
• Last Updated: May 17, 2011

Record last verified: 2010-12