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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00236366
Recruitment Status : Completed
First Posted : October 12, 2005
Last Update Posted : May 17, 2011
Information provided by:
Janssen Pharmaceutica N.V., Belgium

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Arthritis Drug: fentanyl Phase 4

Detailed Description:
Chronic, non-cancer pain may result from injury or illness, such as osteoarthritis or rheumatoid arthritis, which causes suffering and a reduction in the quality of life. Opioids, such as fentanyl, are beneficial as potent pain-relieving drugs in patients with continuous pain. This is double-blind, parallel-group, placebo-controlled study to compare pain relief, and the effect on safety, functionality, and quality of life during treatment with fentanyl administered through the skin via adhesive patches ("transdermal system") with therapy with placebo in patients with osteoarthritis (OA). Specifically, patients with moderate to severe pain induced by osteoarthritis and for whom treatment with traditional pain medication (according to the World Health Organization [WHO] pain ladder, up to and including weak opioids) has failed to provide adequate pain relief, are eligible to enroll. After screening, patients enter a 1-week Run-In period, in which prior treatment with weak opioids, with or without non-opioid pain medication, continues. After this period, patients with moderate to severe pain are randomized to the fentanyl adhesive patch or placebo during the Double-Blind (Treatment) phase for 6 weeks. All patients, including those who discontinue or withdraw from the study, enter the Tapering-Off period, during which the medication is reduced gradually. Assessments of effectiveness include: Pain relief, determined with a Visual Analogue Scale (VAS) by means of an electronic pain diary updated by the patient at least twice daily; functionality, assessed by the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index; and quality of life, measured by the SF-36 Quality of Life Questionnaire. Safety assessments include identification of possible withdrawal symptoms at the end of the Tapering-Off period, measurement of vital signs at stated intervals, and incidence of adverse events throughout the study. The study hypothesis is that patients with osteoarthritis of the hip or knee whose pain is not adequately controlled by other pain-relieving medications will show an improvement in pain control after treatment with the fentanyl transdermal system. Fentanyl patches to deliver 25 micrograms/hour to 100 micrograms/hour, changed every 3 days, for 6 weeks; doses may be adjusted for adequate pain control; anti-nausea tablets (Metoclopramide, 10 milligrams[mg], and paracetamol tablets (500 mg; maximum 4 grams/day) as supplementary pain control

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 418 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre Trial To Investigate Durogesic™ In Comparison To Placebo In Subjects With Moderate To Severe Pain Induced By Osteoarthritis Of The Hip Or The Knee, Who Are In Need Of And Waiting For Hip Or Knee Replacement.
Study Start Date : June 2002
Actual Study Completion Date : April 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Primary Outcome Measures :
  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 Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   41 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00236366

Sponsors and Collaborators
Janssen Pharmaceutica N.V., Belgium
Study Director: Janssen Pharmaceutica N.V. Clinical Trial Janssen Pharmaceutica N.V.

Additional Information: Identifier: NCT00236366     History of Changes
Other Study ID Numbers: CR003004
First Posted: October 12, 2005    Key Record Dates
Last Update Posted: May 17, 2011
Last Verified: December 2010

Keywords provided by Janssen Pharmaceutica N.V., Belgium:
opioid analgesics
transdermal administration

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General