Low Back PainNCT00797017
Study on Impact of Fentanyl Matrix on Improvement of Pain and Functioning in Spinal Disorder-related Pain
An observational study of Low Back Pain, run by Janssen Korea, Ltd., Korea.
Trial summary
The purpose of this observational study is to investigate the impact of fentanyl matrix on improvement of pain and functioning in spinal disorder-related chronic pain. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- fentanyl
- How many people
- 1,576 participants
- Where
- No sites listed yet
- Study dates
- May 2008to Dec 2008
- 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: Patients who had unsatisfactory treatment with previous medication (severe pain: NRS = 7) and no experience with fentanyl matrix will be eligible
Who may be able to join
- Patients who complain of spinal disorder-related chronic pain persisting for 3 months or longer
- Patients who can fully observe the overall clinical study requirements including K-ODI 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 fentanyl matrix 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 patients 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: Impact of Fentanyl Matrix on Improvement of Pain and Functioning in Spinal Disorder-related Pain: Multicenter, Open Label, Prospective, Observational Study
The purpose of this observational study is to investigate the impact of fentanyl matrix on improvement of pain and functioning in spinal disorder-related chronic pain.
Read the detailed description
This study is a prospective, open-label, non-interventional study. The objective of the study is to investigate the impact of fentanyl matrix on improvement of pain and functioning after 8-week treatment of fentanyl matrix in the patients who complained of spinal disorder-related chronic pain in clinical practice according to the investigator's discretion. The primary endpoint is a percent of pain intensity difference between baseline and week 8 of the study. Each patients will evaluate their pain intensity every 28 days during the 8 weeks. The secondary objectives are to observe the change in the following variables after administrating fentanyl matrix; K-ODI (Korean version - Oswestry Disability Index) score, sleep disturbance, disturbance of activities of daily living and disturbance of social activities. In addition, Investigator and patient global assessment, patient preference, CGI-I (Clinical Global Impression - Improvement) and Adverse Events will be investigated. LDK: Lumbar degenerative kyphosis, CRPS: Complex Regional Pain SYndrome, FBSS: Failed Back Surgery Syndrome Observational Study - No investigational drug administered
- Conditions
- Low Back Pain
- Being tested
- fentanyl
- Keywords
- Chronic Pain, Fentanyl Matrix, Spinal disorder-related pain
- Medical subject headings
- Low Back Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fentanylDrug
Infection, starting with 12mcg/h (flexible dose)
fentanylDrug
(CRPS) Complex Regional Pain Syndrome, starting with 12mcg/h (flexible dose)
fentanylDrug
Bone Fracture, starting with 12mcg/h (flexible dose)
fentanylDrug
(FBSS) Failed Back Surgery Syndrome, starting with 12mcg/h (flexible dose)
fentanylDrug
Other Deformity, starting with 12mcg/h (flexible dose)
fentanylDrug
(LDK) Lumbar Degenerative Kyphosis, starting with 12mcg/h (flexible dose)
fentanylDrug
Degenerative Spine Disorder, starting with 12mcg/h (flexible dose)
| Study group | Role | What they receive |
|---|---|---|
| 001 | Not described Receives: Drug: fentanyl | |
| 002 | Not described Receives: Drug: fentanyl | |
| 003 | Not described Receives: Drug: fentanyl | |
| 004 | Not described Receives: Drug: fentanyl | |
| 005 | Not described Receives: Drug: fentanyl | |
| 006 | Not described Receives: Drug: fentanyl | |
| 007 | Not described Receives: Drug: fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity with Numeric Rating Scale
Measured: baseline, week 4 and week 8
Secondary outcomes (5)
Impact of activity of daily living and social activities
Measured: baseline, week 4 and week 8
Investigator and patient global assessment
Measured: baseline, week 4 and week 8
CGI-I (Clinical Global Impression)
Measured: baseline, week 4 and week 8
K-ODI (Korean version of Oswestry Disability Index)
Measured: baseline, week 4 and week 8
Improvement of sleep disturbance
Measured: baseline, 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 posted24 Nov 2008 (estimated)
- Study startMay 2008
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back 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
- 1,576 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
- NCT00797017
- Sponsor's protocol ID
- CR015409
- Status last verified
- Apr 2014
- First submitted
- 20 Nov 2008
- Last updated
- 28 Apr 2014
- Results posted
- No
- Data monitoring committee
- 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
- Impact of Fentanyl Matrix on Improvement of Pain and Functioning in Spinal Disorder-related Pain: Multicenter, Open Label, Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT00797017
- Acronym / sponsor ID
- CR015409
- Conditions
- Low Back Pain
- Keywords
- Chronic Pain, Fentanyl Matrix, Spinal disorder-related pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,576 participants (actual)
- Lead sponsor
- Janssen Korea, Ltd., KoreaIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 24 Nov 2008 (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 observational study is to investigate the impact of fentanyl matrix on improvement of pain and functioning in spinal disorder-related chronic pain.
Detailed description
This study is a prospective, open-label, non-interventional study. The objective of the study is to investigate the impact of fentanyl matrix on improvement of pain and functioning after 8-week treatment of fentanyl matrix in the patients who complained of spinal disorder-related chronic pain in clinical practice according to the investigator's discretion. The primary endpoint is a percent of pain intensity difference between baseline and week 8 of the study. Each patients will evaluate their pain intensity every 28 days during the 8 weeks. The secondary objectives are to observe the change in the following variables after administrating fentanyl matrix; K-ODI (Korean version - Oswestry Disability Index) score, sleep disturbance, disturbance of activities of daily living and disturbance of social activities. In addition, Investigator and patient global assessment, patient preference, CGI-I (Clinical Global Impression - Improvement) and Adverse Events will be investigated. LDK: Lumbar degenerative kyphosis, CRPS: Complex Regional Pain SYndrome, FBSS: Failed Back Surgery Syndrome Observational Study - No investigational drug administered
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 001 | – | Drug: fentanyl |
| 002 | – | Drug: fentanyl |
| 003 | – | Drug: fentanyl |
| 004 | – | Drug: fentanyl |
| 005 | – | Drug: fentanyl |
| 006 | – | Drug: fentanyl |
| 007 | – | Drug: fentanyl |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who had unsatisfactory treatment with previous medication (severe pain: NRS = 7) and no experience with fentanyl matrix will be eligible
Key inclusion criteria (4 listed)
- Patients who complain of spinal disorder-related chronic pain persisting for 3 months or longer
- Patients who can fully observe the overall clinical study requirements including K-ODI 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 fentanyl matrix 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 patients 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 |
|---|---|---|
| fentanylInfection, starting with 12mcg/h (flexible dose) | Drug | 005 |
| fentanyl(CRPS) Complex Regional Pain Syndrome, starting with 12mcg/h (flexible dose) | Drug | 004 |
| fentanylBone Fracture, starting with 12mcg/h (flexible dose) | Drug | 003 |
| fentanyl(FBSS) Failed Back Surgery Syndrome, starting with 12mcg/h (flexible dose) | Drug | 006 |
| fentanylOther Deformity, starting with 12mcg/h (flexible dose) | Drug | 007 |
| fentanyl(LDK) Lumbar Degenerative Kyphosis, starting with 12mcg/h (flexible dose) | Drug | 002 |
| fentanylDegenerative Spine Disorder, starting with 12mcg/h (flexible dose) | Drug | 001 |
Primary outcome
Pain intensity with Numeric Rating Scale
Time frame: baseline, week 4 and week 8
5 secondary outcomes
Impact of activity of daily living and social activities
Time frame: baseline, week 4 and week 8
Investigator and patient global assessment
Time frame: baseline, week 4 and week 8
CGI-I (Clinical Global Impression)
Time frame: baseline, week 4 and week 8
K-ODI (Korean version of Oswestry Disability Index)
Time frame: baseline, week 4 and week 8
Improvement of sleep disturbance
Time frame: baseline, 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 Low Back Pain, 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?
Pain intensity with Numeric Rating Scale (time frame: baseline, week 4 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.