A Study of the Effect on Pain Control of Treatment With Fentanyl, Administered Through the Skin, in Patients With Rheumatoid Arthritis or Osteoarthritis

This study has been completed.
Sponsor:
Information provided by:
Janssen Pharmaceutica N.V., Belgium
ClinicalTrials.gov Identifier:
NCT00524160
First received: August 31, 2007
Last updated: November 24, 2010
Last verified: November 2010
  Purpose

The purpose of this study is to assess the degree of pain control achieved by treatment with fentanyl, administered via adhesive patches applied to the skin ('transdermal system") in patients with rheumatoid arthritis or osteoarthritis of the knee or hip. Treatment will be administered fo r4 weeks, added on to existing therapy with other medications.


Condition Intervention Phase
Arthritis
Osteoarthritis
Rheumatoid Arthritis
Drug: Fentanyl transdermal patch
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-Label Study To Assess The Effect On Pain Control Of Durogesic (Fentanyl Transdermic Therapeutic System) Treatment In Subjects With Rheumatoid Arthritis Or Osteoarthritis Of The Knee Or Hip.

Resource links provided by NLM:


Further study details as provided by Janssen Pharmaceutica N.V., Belgium:

Primary Outcome Measures:
  • Assessment of pain control (excellent, good, moderate, poor, very poor) and Pain Assessment Questionnaire at baseline and then weekly through Day 28.

Secondary Outcome Measures:
  • Incidence of adverse events throughout study; efficacy of anti-nausea treatment (weekly); SF-36 Quality of Life Questionnaire and Health Assessment Questionnaire (HAQ) at start of treatment and Day 28.

Enrollment: 264
Study Start Date: July 2001
Study Completion Date: December 2002
Detailed Description:

Chronic, non-cancer pain may result from injury or illness, such as rheumatoid arthritis or osteoarthritis, 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 an open-label, prospective study to assess the degree of pain control provided by treatment with fentanyl administered through the skin via adhesive patches ("transdermal system") for 28 days in patients with rheumatoid arthritis or osteoarthritis of the hip or knee, whose pain is inadequately controlled by other medications. During the first week of treatment, a prophylactic anti-nausea and vomiting agent will be given to patients to control these symptoms that can occur during opioid therapy. After 28 days, patients who do not respond adequately to treatment will be tapered off by gradually reducing the dose of fentanyl. Assessment of effectiveness will include a rating of pain control (excellent, good, moderate, poor, very poor), Pain Assessment Questionnaire, Quality of Life Questionnaire (SF-36), Health Assessment Questionnaire (HAQ), recording of the usage of any additional pain-relieving medications, and an evaluation of the anti-nausea and vomiting treatment. Safety evaluations include incidence of adverse events, and physical examinations. The study hypothesis is that patients with rheumatoid arthritis or osteoarthritis of the hip or knee whose pain is not adequately controlled by other medications will show an improvement in pain control after 28 days of treatment with the fentanyl transdermal system. Fentanyl transdermal patches to deliver from 25 micrograms/hr to 100 micrograms/hr, changed every 3 days, for 28 days; doses may be adjusted for adequate pain control, Anti-nausea tablets (Metoclopramide, 10 mg, 3 times/day) during first week. Paracetamol tablets (500mg) to supplement pain control.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must meet the American College of Rheumatology criteria for rheumatoid arthritis (RA) or osteoarthritis (OA) of the hip or knee and have moderate or severe pain that is not adequately controlled by other medications (paracetamol (acetaminophen), NSAIDs, COX-2 inhibitors, weak opioids)
  • OA patients must be in need of and waiting for hip or knee replacement
  • RA patients using disease modifying antirheumatic drugs (DMARDs) must have been on stable dose of medication for >=3 months.

Exclusion Criteria:

  • Patients who have received regular treatment with strong opioids during the month prior to study
  • another continuous pain that stands out compared to RA or OA pain
  • skin disease or known allergy or hypersensitivity to fentanyl or to the adhesives
  • history of liver disease
  • new physical therapy or change in that therapy within one month of study
  • pregnant or nursing females, or those without adequate contraception.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00524160

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

Publications:
ClinicalTrials.gov Identifier: NCT00524160     History of Changes
Other Study ID Numbers: CR001981
Study First Received: August 31, 2007
Last Updated: November 24, 2010
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment

Keywords provided by Janssen Pharmaceutica N.V., Belgium:
Fentanyl
opioid analgesics
arthritis
osteoarthritis
rheumatoid arthritis
transdermal administration

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Osteoarthritis
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Fentanyl
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid

ClinicalTrials.gov processed this record on July 20, 2014