PainNCT01816503
Fentanyl Matrix Application for Cancer Pain: Multicenter, Prospective, Observational Study
An observational study of Pain, run by Janssen Korea, Ltd., Korea.
Trial summary
The purpose of this study is to show the clinical usefulness of fentanyl matrix by measuring satisfaction with pain treatment after administering fentanyl matrix in patients whose pain was not controlled sufficiently with the previous analgesic use in real practice at the investigator's discretion. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Pain
- How many people
- 636 participants
- Where
- No sites listed yet
- Study dates
- Dec 2008to Jul 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: Patients who are admitted to a study center during the study period and are receiving a strong oral long-acting opioid analgesic but deemed to control pain insufficiently.
Who may be able to join
- Patients complaining of cancer pain which requires administration of long-acting opioid analgesics
- Patients whose pain is not sufficiently controlled despite administration of strong long-acting opioid analgesics
- Patients who are deemed to need an initial minimum dose of fentanyl matrix 75 micrograms/h
- Patients who signed the informed consent form
Who cannot join
- Patients with a history of or current drug or alcohol abuse
- Childbearing women who are pregnant or likely to be pregnant during the study period and men who are neither infertile nor willing to refrain from sexual relations but whose partner does not conduct an effective contraception
- Patients who are unable to use a transdermal system due to skin disease
- Patients with history of hypersensitivity to opioid analgesics
- Patients who are not eligible for the study participation based on warnings, precautions and contraindications in the package insert of the study drug at the investigator's discretion
About this study
Official title: High-dose Fentanyl Matrix Application for Cancer Pain: Multicenter, Prospective, Observational Study
The purpose of this study is to show the clinical usefulness of fentanyl matrix by measuring satisfaction with pain treatment after administering fentanyl matrix in patients whose pain was not controlled sufficiently with the previous analgesic use in real practice at the investigator's discretion.
Read the detailed description
This is a multi-center, open-label (all people know the identity of the intervention), prospective (the patients are identified and then followed forward in time for the outcome of the study) observational study. The study population comprises patients who are admitted to a study center during the study period and are receiving a strong oral long-acting opioid analgesic but deemed to control pain insufficiently. Since this study is an observational study conducted in real practice, a dose of fentanyl matrix should be adjusted depending on an individual patient's response at the investigator's discretion. However, for the patients whose pain is not sufficiently controlled despite administration of strong long-acting opioid analgesics, the minimum initial dose will be fentanyl matrix 75 micrograms/h and the investigator can adjust dosage according to the degree of the patients' pain control during the 9 days of the study period.
- Conditions
- Pain
- Being tested
- No intervention
- Keywords
- Pain, Cancer pain, Fentanyl, Fentanyl matrix, Opioid analgesic
- Medical subject headings
- Pain, Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionDrug
This is an observational study. The minimum initial dose will be fentanyl matrix 75 micrograms/h and the investigator can adjust the dosage according to the degree of the patients' pain control during the 9 days of the study period. Fentanyl matrix is a transdermal patch that is applied on the patient's skin.
| Study group | Role | What they receive |
|---|---|---|
| Fentanyl matrix | Not described Receives: Drug: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of patients who are very satisfied or satisfied with the pain treatment after the study drug administration
The overall satisfaction is measured by a 5-point scale. Patients' answers are rated as: "very satisfied", "satisfied", "fair", "dissatisfied", or "very dissatisfied".
Measured: Day 10
Secondary outcomes (8)
The change from baseline in pain intensity
The mean pain intensity the patient experienced over the last 24 hours will be measured through Numeric Rating Scale (NRS); 0 = no pain, 10 = worst pain imaginable.
Measured: Baseline, up to Day 10
The change from baseline in Karnofsky Performance Status Scale
Karnofsky Performance Status Rating Scale is a tool to assess cancer patients' physical functioning. Scores range from 0 per cent (dead) to 100 per cent (normal, no complaints, no evidence of disease) in a unit of 10 per cent to indicate a level of overall daily activity performance status.
Measured: Baseline, Day 10
Sleep disturbance caused by the number of awakening caused by pain the patient experienced over the last night
Patients indicate in a Numeric Rating Scale (NRS) the number of awakening from sleep due to pain in the previous night: not awakened, once, twice, more than 3 times, or could not sleep.
Measured: 10 days
Sleep disturbance caused by pain the patient experienced over the last 24 hours
Patients indicate in a Numeric Rating Scale (NRS) the sleep disturbance caused by pain experienced over the last 24 hours, where 0= not disturbing at all, and 10= very disturbing.
Measured: 10 days
The change from baseline in Clinical Global Impression - Improvement (CGI-I)
CGI-I measures the overall improvement of the patient's condition compared to baseline, as follows; 1 = Improved very much, 2 = Improved a lot, 3 = Improved a little, 4 = No change, 5 = Aggravated a little, 6= Aggravated a lot, 7= Aggravated very much.
Measured: Baseline, Day 10
Patient's Global Assessment
This tool assesses how effective the study drug has been in pain treatment during the study period. The patient will assess the effectiveness from his/her viewpoint at visit 10 on a 5-point rating scale; 1 = not effective, 2 = fair, 3 = effective, 4 = very effective, 5 = very much effective.
Measured: Day 10
Investigator's Global Assessment
This tool assesses how effective the study drug has been during the study period. The investigator will assess the effectiveness from his/her viewpoint at Visit 10 on a 5-point rating scale; 1 = not effective, 2 = fair, 3 = effective, 4 = very effective, 5 = very much effective.
Measured: Day 10
Dose of fentanyl matrix
The dose of fentanyl matrix used throughout the study.
Measured: 9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2013 (estimated)
- Study startDec 2008
- Primary completionJul 2009
- Study completionJul 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
- 636 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
- NCT01816503
- Sponsor's protocol ID
- CR015778
- Other IDs
- FENPAI4084, FEN-KOR-5027
- Status last verified
- Mar 2013
- First submitted
- 20 Mar 2013
- Last updated
- 22 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-dose Fentanyl Matrix Application for Cancer Pain: Multicenter, Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT01816503
- Acronym / sponsor ID
- CR015778
- Conditions
- Pain
- Keywords
- Pain, Cancer pain, Fentanyl, Fentanyl matrix, Opioid analgesic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 636 participants (actual)
- Lead sponsor
- Janssen Korea, Ltd., KoreaIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 22 Mar 2013 (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 show the clinical usefulness of fentanyl matrix by measuring satisfaction with pain treatment after administering fentanyl matrix in patients whose pain was not controlled sufficiently with the previous analgesic use in real practice at the investigator's discretion.
Detailed description
This is a multi-center, open-label (all people know the identity of the intervention), prospective (the patients are identified and then followed forward in time for the outcome of the study) observational study. The study population comprises patients who are admitted to a study center during the study period and are receiving a strong oral long-acting opioid analgesic but deemed to control pain insufficiently. Since this study is an observational study conducted in real practice, a dose of fentanyl matrix should be adjusted depending on an individual patient's response at the investigator's discretion. However, for the patients whose pain is not sufficiently controlled despite administration of strong long-acting opioid analgesics, the minimum initial dose will be fentanyl matrix 75 micrograms/h and the investigator can adjust dosage according to the degree of the patients' pain control during the 9 days of the study period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fentanyl matrix | – | Drug: No intervention |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are admitted to a study center during the study period and are receiving a strong oral long-acting opioid analgesic but deemed to control pain insufficiently.
Key inclusion criteria (4 listed)
- Patients complaining of cancer pain which requires administration of long-acting opioid analgesics
- Patients whose pain is not sufficiently controlled despite administration of strong long-acting opioid analgesics
- Patients who are deemed to need an initial minimum dose of fentanyl matrix 75 micrograms/h
- Patients who signed the informed consent form
Key exclusion criteria (5 listed)
- Patients with a history of or current drug or alcohol abuse
- Childbearing women who are pregnant or likely to be pregnant during the study period and men who are neither infertile nor willing to refrain from sexual relations but whose partner does not conduct an effective contraception
- Patients who are unable to use a transdermal system due to skin disease
- Patients with history of hypersensitivity to opioid analgesics
- Patients who are not eligible for the study participation based on warnings, precautions and contraindications in the package insert of the study drug at the investigator's discretion
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 |
|---|---|---|
| No interventionThis is an observational study. The minimum initial dose will be fentanyl matrix 75 micrograms/h and the investigator can adjust the dosage according to the degree of the patients' pain control during the 9 days of the study period. Fentanyl matrix is a transdermal patch that is applied on the patient's skin. | Drug | Fentanyl matrix |
Primary outcome
The percentage of patients who are very satisfied or satisfied with the pain treatment after the study drug administration
Time frame: Day 10
The overall satisfaction is measured by a 5-point scale. Patients' answers are rated as: "very satisfied", "satisfied", "fair", "dissatisfied", or "very dissatisfied".
8 secondary outcomes
The change from baseline in pain intensity
Time frame: Baseline, up to Day 10
The change from baseline in Karnofsky Performance Status Scale
Time frame: Baseline, Day 10
Sleep disturbance caused by the number of awakening caused by pain the patient experienced over the last night
Time frame: 10 days
Sleep disturbance caused by pain the patient experienced over the last 24 hours
Time frame: 10 days
The change from baseline in Clinical Global Impression - Improvement (CGI-I)
Time frame: Baseline, Day 10
Patient's Global Assessment
Time frame: Day 10
Investigator's Global Assessment
Time frame: Day 10
Dose of fentanyl matrix
Time frame: 9 days
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 22 Mar 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
Questions about this trial
What is this clinical trial studying?
An observational study of 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 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 22 Mar 2013. 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?
The percentage of patients who are very satisfied or satisfied with the pain treatment after the study drug administration (time frame: Day 10). 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 22 Mar 2013.