NCT00524160

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
264

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2001

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2001

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2002

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 3, 2007

Completed
Last Updated

November 25, 2010

Status Verified

November 1, 2010

First QC Date

August 31, 2007

Last Update Submit

November 24, 2010

Conditions

ArthritisOsteoarthritisRheumatoid Arthritis

Keywords

Fentanylopioid analgesicsarthritisosteoarthritisrheumatoid arthritistransdermal administration

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

  • 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.

Interventions

Fentanyl transdermal patchDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Pavelka K, Le Loet X, Bjorneboe O, Herrero-Beaumont G, Richarz U. Benefits of transdermal fentanyl in patients with rheumatoid arthritis or with osteoarthritis of the knee or hip: an open-label study to assess pain control. Curr Med Res Opin. 2004 Dec;20(12):1967-77. doi: 10.1185/030079904X14120.

    PMID: 15701214RESULT

  • Herrero-Beaumont G, Bjorneboe O, Richarz U. Transdermal fentanyl for the treatment of pain caused by rheumatoid arthritis. Rheumatol Int. 2004 Nov;24(6):325-32. doi: 10.1007/s00296-004-0520-7. Epub 2004 Oct 5.

    PMID: 15480678RESULT

  • Le Loet X, Pavelka K, Richarz U. Transdermal fentanyl for the treatment of pain caused by osteoarthritis of the knee or hip: an open, multicentre study. BMC Musculoskelet Disord. 2005 Jun 15;6:31. doi: 10.1186/1471-2474-6-31.

    PMID: 15958159RESULT

MeSH Terms

Conditions

ArthritisOsteoarthritisArthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Janssen Pharmaceutica N.V. Clinical Trial

    Janssen Pharmaceutica N.V.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 31, 2007

First Posted

September 3, 2007

Study Start

July 1, 2001

Study Completion

December 1, 2002

Last Updated

November 25, 2010

Record last verified: 2010-11