Chronic PainNCT01688583
The Effectiveness and Tolerability of Fentanyl Matrix in Chronic Non-cancer Pain; Assessment of Patient's Pain Treatment Goal Achievement
An observational study of Chronic Pain, run by Janssen Korea, Ltd., Korea at 11 sites in South Korea.
Trial summary
The purpose of this study is to assess the effectiveness and tolerability of Fentanyl matrix in chronic non-cancer pain. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Fentanyl matrix
- How many people
- 410 participants
- Where
- 11 sitesSouth Korea
- Study dates
- Dec 2011to Mar 2013
- 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 complain of chronic pain and have pain inadequately controlled by previous treatment with narcotic analgesics (eg, tramadols, codeines, morphines, oxycodone), and are judged to require Fentanyl matrix administration will participate in this study.
Who may be able to join
- Complain of chronic non-cancer pain that persists for >= 3 months
- Pain inadequately controlled by previous treatment with narcotic analgesics (opium or opium-like compounds with potent analgesic effects, eg, tramadol, codeine, morphine, oxycodone)
- Women must be postmenopausal, surgically sterile, abstinent, or practicing an effective method of birth control if they have childbearing potential
- Male patients who agree to use a method of birth control and not to donate sperm for 1 month after the last dose of the study drug
- A written informed consent for study participation
Who cannot join
- Experience of treatment with Fentanyl matrix within the past 4 weeks
- No previous experience of use of narcotic analgesics
- Past or current history of alcohol or drug abuse
- Cannot use transdermal analgesics due to skin disorder
- Have serious psychiatric disorder and cannot complete overall study procedures and questionnaire in the judgment of the investigator
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
South Korea11 sites
Study site
Andong
Study site
Busan
Study site
Daegu
Study site
Daejeon
Study site
Goyang
Study site
Incheon
Study site
Jeonju
Study site
Kwangiu
Study site
Kwanju
Study site
Seoul
Study site
Wŏnju
About this study
Official title: The Effectiveness and Tolerability of Fentanyl Matrix in Chronic Non-cancer Pain; Assessment of Patient's Pain Treatment Goal Achievement: Multicenter, Prospective, Open-label, Observational Study
The purpose of this study is to assess the effectiveness and tolerability of Fentanyl matrix in chronic non-cancer pain.
Read the detailed description
This is a multicenter, prospective (a study in which the patients are identified and then followed forward in time for the outcome of the study), open-label (all people know the identity of the intervention), observational study intended to examine the effectiveness of Fentanyl matrix through the degree of improvement of pain. Fentanyl matrix is a transdermal (through the skin) system providing continuous delivery of fentanyl for 72 hours. Fentanyl matrix will be administered to patients with chronic (prolonged) non-cancer pain under routine practice during 12 weeks. Dose will be adjusted in accordance with patient's degree of pain and treatment response in the investigator's judgment.
- Conditions
- Chronic Pain
- Being tested
- Fentanyl matrix
- Keywords
- Chronic pain, Chronic non-cancer pain, Fentanyl matrix, Transdermal system
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl matrixDrug
Dose will be adjusted in accordance with patient's degree of pain and treatment response in the investigator's judgment.
| Study group | Role | What they receive |
|---|---|---|
| Fentanyl matrix | Not described Receives: Drug: Fentanyl matrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of patients with mean % Pain Intensity Difference (%PID) >= 50% from baseline to endpoint
Pain intensity will be measured using a numeric rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable).
Measured: 12 weeks
Secondary outcomes (7)
The change from baseline in mean pain intensity
Pain intensity will be measured using a numeric rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable).
Measured: Baseline, Week 12
The difference between the patient's pain treatment goal set at baseline
The degree of pain the patient wishes to achieve by the end of treatment, set at baseline. The degree of pain will be measured using a numeric rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable).
Measured: Baseline, Week 12
The degree of night sleep disturbance due to pain
Sleep disturbance due to pain will be measured using a Numeric Rating Scale (NRS): 1 = None, 10 = Complete.
Measured: 12 weeks
The degree of Interference with Daily Life Performance due to Pain
The degree of interference with daily life performance due to pain will be assessed on a 5-point scale: 1 = No interference, 5 = Great interference. Daily life performance means household work performance, etc.
Measured: 12 weeks
The degree of Interference with Social Life Performance due to Pain
The degree of interference with social life performance due to pain will be measured on a 5-point scale; 1 = No interference, 5 = Great interference. Social life performance means interpersonal relationship, going out, working life, etc.
Measured: 12 weeks
The patient's global assessment of pain treatment
The patient will assess on a 5-point scale (1= not effective, 5= greatly effective) how effective the study drug has been in the judgment of the study participant.
Measured: 12 weeks
The investigator's global assessment of pain treatment
The investigator will assess on a 5-point scale (1= not effective, 5= greatly effective) how effective the study drug has been for a patient, in the judgment of the investigator.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2012 (estimated)
- Study startDec 2011
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- 410 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Korea, Ltd., Korea
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Korea, Ltd., Korea Clinical Trial, Study director, Janssen Korea, Ltd., Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01688583
- Sponsor's protocol ID
- CR100728
- Other IDs
- FENPAI4094, FEN-KOR-5045
- Status last verified
- Nov 2013
- First submitted
- 17 Sep 2012
- Last updated
- 21 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness and Tolerability of Fentanyl Matrix in Chronic Non-cancer Pain; Assessment of Patient's Pain Treatment Goal Achievement: Multicenter, Prospective, Open-label, Observational Study
- ClinicalTrials.gov ID
- NCT01688583
- Acronym / sponsor ID
- CR100728
- Conditions
- Chronic Pain
- Keywords
- Chronic pain, Chronic non-cancer pain, Fentanyl matrix, Transdermal system
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 410 participants (actual)
- Lead sponsor
- Janssen Korea, Ltd., KoreaIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 20 Sep 2012 (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 effectiveness and tolerability of Fentanyl matrix in chronic non-cancer pain.
Detailed description
This is a multicenter, prospective (a study in which the patients are identified and then followed forward in time for the outcome of the study), open-label (all people know the identity of the intervention), observational study intended to examine the effectiveness of Fentanyl matrix through the degree of improvement of pain. Fentanyl matrix is a transdermal (through the skin) system providing continuous delivery of fentanyl for 72 hours. Fentanyl matrix will be administered to patients with chronic (prolonged) non-cancer pain under routine practice during 12 weeks. Dose will be adjusted in accordance with patient's degree of pain and treatment response in the investigator's judgment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fentanyl matrix | – | Drug: Fentanyl matrix |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who complain of chronic pain and have pain inadequately controlled by previous treatment with narcotic analgesics (eg, tramadols, codeines, morphines, oxycodone), and are judged to require Fentanyl matrix administration will participate in this study.
Key inclusion criteria (5 listed)
- Complain of chronic non-cancer pain that persists for >= 3 months
- Pain inadequately controlled by previous treatment with narcotic analgesics (opium or opium-like compounds with potent analgesic effects, eg, tramadol, codeine, morphine, oxycodone)
- Women must be postmenopausal, surgically sterile, abstinent, or practicing an effective method of birth control if they have childbearing potential
- Male patients who agree to use a method of birth control and not to donate sperm for 1 month after the last dose of the study drug
- A written informed consent for study participation
Key exclusion criteria (5 listed)
- Experience of treatment with Fentanyl matrix within the past 4 weeks
- No previous experience of use of narcotic analgesics
- Past or current history of alcohol or drug abuse
- Cannot use transdermal analgesics due to skin disorder
- Have serious psychiatric disorder and cannot complete overall study procedures and questionnaire in the judgment of the investigator
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 matrixDose will be adjusted in accordance with patient's degree of pain and treatment response in the investigator's judgment. | Drug | Fentanyl matrix |
Primary outcome
The percentage of patients with mean % Pain Intensity Difference (%PID) >= 50% from baseline to endpoint
Time frame: 12 weeks
Pain intensity will be measured using a numeric rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable).
7 secondary outcomes
The change from baseline in mean pain intensity
Time frame: Baseline, Week 12
The difference between the patient's pain treatment goal set at baseline
Time frame: Baseline, Week 12
The degree of night sleep disturbance due to pain
Time frame: 12 weeks
The degree of Interference with Daily Life Performance due to Pain
Time frame: 12 weeks
The degree of Interference with Social Life Performance due to Pain
Time frame: 12 weeks
The patient's global assessment of pain treatment
Time frame: 12 weeks
The investigator's global assessment of pain treatment
Time frame: 12 weeks
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 21 Nov 2013.
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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., Korea Clinical Trial study director
Janssen Korea, Ltd., Korea
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by Janssen Korea, Ltd., Korea at 11 sites in South 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 5 inclusion and 5 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 21 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The percentage of patients with mean % Pain Intensity Difference (%PID) >= 50% from baseline to endpoint (time frame: 12 weeks). 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 21 Nov 2013.