ArthritisPhase 4NCT00524160
A Study of the Effect on Pain Control of Treatment With Fentanyl, Administered Through the Skin, in Patients With Rheumatoid Arthritis or Osteoarthritis
A Phase 4 study testing Fentanyl transdermal patch in people with Arthritis and Osteoarthritis, run by Janssen Pharmaceutica N.V., Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Osteoarthritis, Rheumatoid Arthritis
- What is being tested?
- Fentanyl transdermal patch
- How many people
- 264 participants
- Where
- No sites listed yet
- Study dates
- Jul 2001to Dec 2002
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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.
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.
Read the 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.
- Conditions
- Arthritis, Osteoarthritis, Rheumatoid Arthritis
- Being tested
- Fentanyl transdermal patch
- Keywords
- Fentanyl, opioid analgesics, arthritis, osteoarthritis, rheumatoid arthritis, transdermal administration
- Medical subject headings
- Arthritis, Osteoarthritis, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl transdermal patchDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2007 (estimated)
- Study startJul 2001
- Study completionDec 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Pharmaceutica N.V., Belgium
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Janssen Pharmaceutica N.V. Clinical Trial, Study director, Janssen Pharmaceutica N.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00524160
- Sponsor's protocol ID
- CR001981
- Status last verified
- Nov 2010
- First submitted
- 31 Aug 2007
- Last updated
- 25 Nov 2010
- Results posted
- No
Publications
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.
PubMed 15701214Herrero-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.
PubMed 15480678Le 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.
PubMed 15958159
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00524160
- Acronym / sponsor ID
- CR001981
- Conditions
- Arthritis, Osteoarthritis, Rheumatoid Arthritis
- Keywords
- Fentanyl, opioid analgesics, arthritis, osteoarthritis, rheumatoid arthritis, transdermal administration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- Janssen Pharmaceutica N.V., BelgiumIndustry (pharma, biotech, devices)
- Study start
- Jul 2001
- Study completion
- Dec 2002 (actual)
- First posted
- 3 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fentanyl transdermal patch | Drug | – |
Primary outcome
Assessment of pain control (excellent, good, moderate, poor, very poor) and Pain Assessment Questionnaire at baseline and then weekly through Day 28.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2010.
- Results publication: PubMed 15701214Pavelka 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.
- Results publication: PubMed 15480678Herrero-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.
- Results publication: PubMed 15958159Le 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Pharmaceutica N.V. Clinical Trial study director
Janssen Pharmaceutica N.V.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fentanyl transdermal patch in people with Arthritis and Osteoarthritis, run by Janssen Pharmaceutica N.V., Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of pain control (excellent, good, moderate, poor, very poor) and Pain Assessment Questionnaire at baseline and then weekly through Day 28.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00524160, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2010.