PainNCT01119885
Observational Study Investigating the Effectiveness of Fentanyl Matrix in Relieving Pain and Improving Function in Patients With Osteoarthritis of the Knee or Hip
An observational study of Pain and Osteoarthritis, Hip, run by Janssen Korea, Ltd., Korea.
Trial summary
The purpose of this study is to investigate the utility of fentanyl matrix for the treatment of pain due to osteoarthritis (OA) of knee or hip, which was not adequately controlled by non-opioid analgesic (e.g. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Pain, Osteoarthritis, Hip, Osteoarthritis, Knee
- What is being tested?
- fentanyl matrix
- How many people
- 742 participants
- Where
- No sites listed yet
- Study dates
- Aug 2008to Jan 2009
- Phase
- Observational
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population is the patients who visit a center during the study period with the complaint of chronic pain caused by osteoarthritis of the knee or hip, and are deemed to fail to control pain in a proper way and need fentanyl matrix administration according to the investigator's discretion
Who may be able to join
- Patients who complain of chronic pain caused by osteoarthritis of the knee or hip persisting for 3 months or longer
- Patients who can fully observe the overall clinical study requirements including K-WOMAC completion at the investigator's discretion
- Patients who complain of severe pain (NRS score = 7) because pain was not treated enough with the previous analgesic
- Patients who have never been administered strong opioid analgesics over the last one month
Who cannot join
- Patients with a history of the drug or alcohol abuse in the past or now
- Childbearing women who are pregnant or likely to be pregnant during the study period and male subjects who are neither infertile nor willing to refrain from sexual relations but whose partner does not conduct an effective contraception (implant, injections, oral contraceptives, intrauterine device, etc.)
- Patients who are unable to use a transdermal system due to skin disease
- Patients with serious mental disorder
- Patients with history of hypersensitivity to opioid analgesics
- Patients with history of CO2 retention
- Patients who are not eligible for the study participation based on warnings, precautions and contra medications in the package insert of the study drug at the investigator's discretion
About this study
Official title: Fentanyl Matrix for the Treatment of Pain Caused by Osteoarthritis of the Knee or Hip: Improvement of Pain and Function: Multicenter, Open-label, Prospective, Observational Study
The purpose of this study is to investigate the utility of fentanyl matrix for the treatment of pain due to osteoarthritis (OA) of knee or hip, which was not adequately controlled by non-opioid analgesic (e.g. NSAIDs or COX-II inhibitors) or weak opioids [tramadol HClacetaminophen, tramadol or codeine (or combinations with acetaminophen/ibuprofen)].
Read the detailed description
This study is a prospective, open-label, non-interventional study. The objective of this study is to investigate the utility of fentanyl matrix after 8 week treatment of fentanyl matrix for the treatment of pain due to osteoarthritis (OA) of knee or hip, which was not adequately controlled by non-opioid analgesic (e.g. NSAIDs or COX-II selective inhibitors) or weak opioids [tramadol HCl with acetaminophen, tramadol or codeine (or combination with acetaminophen/ibuprofen)] in clinical practice according to the investigator's discretion. This study will investigate the usefulness of fentanyl matrix based on improvement in pain and function after Fentanyl matrix administration in patients who complained of pain caused by osteoarthritis and indicated for Fentanyl matrix administration in clinical practice at the investigator's discretion. This study will also measure the patients' functional improvement through Korean Version of WOMAC. Observational study - No investigational drug administered
- Conditions
- Pain, Osteoarthritis, Hip, Osteoarthritis, Knee
- Being tested
- fentanyl matrix
- Keywords
- chronic pain, fentanyl matrix, arthritis, osteoarthritis
- Medical subject headings
- Pain, Osteoarthritis, Hip, Osteoarthritis, Knee, Chronic Pain, Arthritis, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fentanyl matrixDrug
Knee osteoarthritis, starting with 12mcg/h (flexible dose)
fentanyl matrixDrug
Hip osteoarthritis, starting with 12mcg/h (flexible dose)
| Study group | Role | What they receive |
|---|---|---|
| 001 | fentanyl matrix Knee osteoarthritis starting with 12mcg/h (flexible dose) Receives: Drug: fentanyl matrix | |
| 002 | fentanyl matrix Hip osteoarthritis starting with 12mcg/h (flexible dose) Receives: Drug: fentanyl matrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain intensity from baseline through final evaluation as measured by Numeric Rating Scale
Measured: Baseline and week 8
Secondary outcomes (5)
Improved pain relief as measured using the K-WOMAC scale
Measured: baseline, week 4 and week 8
Improvement of sleep disturbance
Measured: baseline, week 4 and week 8
Impact of activity of daily activities measured by 5-point likert scale and social activities measured by 5-point likert scale
Measured: baseline, week 4 and week 8
Investigator and patient global assessment measured by 5-point likert scale
Measured: Week 4 and week 8
Improved pain relief as measured using the CGI-I
Measured: Week 4 and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2010 (estimated)
- Study startAug 2008
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 742 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Korea, Ltd., Korea
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Korea, Ltd. Clinical Trial, Study director, Janssen Korea, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01119885
- Sponsor's protocol ID
- CR015454
- Status last verified
- Apr 2014
- First submitted
- 29 Jan 2010
- Last updated
- 28 Apr 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fentanyl Matrix for the Treatment of Pain Caused by Osteoarthritis of the Knee or Hip: Improvement of Pain and Function: Multicenter, Open-label, Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT01119885
- Acronym / sponsor ID
- CR015454
- Conditions
- Pain, Osteoarthritis, Hip, Osteoarthritis, Knee
- Keywords
- chronic pain, fentanyl matrix, arthritis, osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 742 participants (actual)
- Lead sponsor
- Janssen Korea, Ltd., KoreaIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 10 May 2010 (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 investigate the utility of fentanyl matrix for the treatment of pain due to osteoarthritis (OA) of knee or hip, which was not adequately controlled by non-opioid analgesic (e.g. NSAIDs or COX-II inhibitors) or weak opioids [tramadol HClacetaminophen, tramadol or codeine (or combinations with acetaminophen/ibuprofen)].
Detailed description
This study is a prospective, open-label, non-interventional study. The objective of this study is to investigate the utility of fentanyl matrix after 8 week treatment of fentanyl matrix for the treatment of pain due to osteoarthritis (OA) of knee or hip, which was not adequately controlled by non-opioid analgesic (e.g. NSAIDs or COX-II selective inhibitors) or weak opioids [tramadol HCl with acetaminophen, tramadol or codeine (or combination with acetaminophen/ibuprofen)] in clinical practice according to the investigator's discretion. This study will investigate the usefulness of fentanyl matrix based on improvement in pain and function after Fentanyl matrix administration in patients who complained of pain caused by osteoarthritis and indicated for Fentanyl matrix administration in clinical practice at the investigator's discretion. This study will also measure the patients' functional improvement through Korean Version of WOMAC. Observational study - No investigational drug administered
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 001 | – | Drug: fentanyl matrixfentanyl matrix Knee osteoarthritis starting with 12mcg/h (flexible dose) |
| 002 | – | Drug: fentanyl matrixfentanyl matrix Hip osteoarthritis starting with 12mcg/h (flexible dose) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is the patients who visit a center during the study period with the complaint of chronic pain caused by osteoarthritis of the knee or hip, and are deemed to fail to control pain in a proper way and need fentanyl matrix administration according to the investigator's discretion
Key inclusion criteria (4 listed)
- Patients who complain of chronic pain caused by osteoarthritis of the knee or hip persisting for 3 months or longer
- Patients who can fully observe the overall clinical study requirements including K-WOMAC completion at the investigator's discretion
- Patients who complain of severe pain (NRS score = 7) because pain was not treated enough with the previous analgesic
- Patients who have never been administered strong opioid analgesics over the last one month
Key exclusion criteria (7 listed)
- Patients with a history of the drug or alcohol abuse in the past or now
- Childbearing women who are pregnant or likely to be pregnant during the study period and male subjects who are neither infertile nor willing to refrain from sexual relations but whose partner does not conduct an effective contraception (implant, injections, oral contraceptives, intrauterine device, etc.)
- Patients who are unable to use a transdermal system due to skin disease
- Patients with serious mental disorder
- Patients with history of hypersensitivity to opioid analgesics
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 matrixKnee osteoarthritis, starting with 12mcg/h (flexible dose) | Drug | 001 |
| fentanyl matrixHip osteoarthritis, starting with 12mcg/h (flexible dose) | Drug | 002 |
Primary outcome
Change in pain intensity from baseline through final evaluation as measured by Numeric Rating Scale
Time frame: Baseline and week 8
5 secondary outcomes
Improved pain relief as measured using the K-WOMAC scale
Time frame: baseline, week 4 and week 8
Improvement of sleep disturbance
Time frame: baseline, week 4 and week 8
Impact of activity of daily activities measured by 5-point likert scale and social activities measured by 5-point likert scale
Time frame: baseline, week 4 and week 8
Investigator and patient global assessment measured by 5-point likert scale
Time frame: Week 4 and week 8
Improved pain relief as measured using the CGI-I
Time frame: Week 4 and week 8
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 28 Apr 2014.
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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 Korea, Ltd. Clinical Trial study director
Janssen Korea, Ltd.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Osteoarthritis, Hip, run by Janssen Korea, Ltd., Korea.
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 4 inclusion and 7 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 28 Apr 2014. 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.
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?
Change in pain intensity from baseline through final evaluation as measured by Numeric Rating Scale (time frame: Baseline and week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Apr 2014.