Lung CancerPhase 4NCT01060137
Fentanyl Matrix in Lung Cancer Pain
A Phase 4 study testing fentanyl matrix in people with Lung Cancer and Pain, run by Janssen Korea, Ltd., Korea.
Trial summary
The purpose of this study is to evaluate the usefulness of fentanyl matrix by assessing patients' satisfaction when administrating fentanyl matrix, a background pain treatment, and a breakthrough pain treatment to lung cancer patients who complain of pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Pain
- What is being tested?
- fentanyl matrix
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 268 participants
- Where
- No sites listed yet
- Study dates
- May 2006to May 2007
- 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 with histologically confirmed lung cancer, who complain of cancer pain
- Patients who are taking Ultracet, Tramadol, or Codeine (or Codeine combination drug) for cancer pain-relief purposes, but still complain of a pain level of 4 or above on the Numeric Rating Scale (NRS) during the past 24 hours: Ultracet 3 tablets/day, Tramadol 150 mg/day, Codeine 200 mg /day, or Codeine combination less than 3 capsules/day
- Patients who are able to communicate with the investigator about his/her pain
- Patients who use proper contraceptives during the study period if they are women of childbearing potential
- Patients whose life expectancy is 3 months or longer
- Patients who have signed an informed consent form
Who cannot join
- Patients participating in other clinical trials
- Patients with a history of hypersensitivity to opioid analgesics
- Patients with a history of drug abuse
- Patients who are unable to use a transdermal product due to skin disease
- Patient with a history of CO2 retention (e.g. chronic obstructive pulmonary disease)
- Patients who are receiving radiotherapy or chemotherapy when registering for the study or who plan to receive it during the study
- Patient who are pregnant or are of childbearing potential and not using contraceptives
About this study
Official title: Evaluation of the Usefulness of DurogesicD-TRANS for Pain Treatment in Lung Cancer Patients
The purpose of this study is to evaluate the usefulness of fentanyl matrix by assessing patients' satisfaction when administrating fentanyl matrix, a background pain treatment, and a breakthrough pain treatment to lung cancer patients who complain of pain. Fentanyl matrix is designed to deliver medication at a nearly constant amount per unit time into the body through the skin for 3 days (72 hours).
Read the detailed description
This study is open-label, single-arm, multicenter, prospective study to evaluate the usefulness of fentanyl matrix (fentanyl transdermal patch-type system) by assessing patient satisfaction when administrating fentanyl matrix (a background pain treatment, and a breakthrough pain treatment) for patients with lung cancer for 21 days. Fentanyl transdermal patch-type system is designed to deliver medication at a nearly constant amount per unit time into the body through the skin for 3 days (72 hours). Studies about transdermal fentanyl have found that it had analgesic effects on malignant pain, and most patients receiving the medication preferred fentanyl because they experienced less constipation. Safety assessments will include adverse event monitoring, vital signs, laboratory work. starting with 12.5g/h or 25g/h of fentanyl matrix transdermally at the investigator's discretion and flexible dose depending the patient's pain relief for 3 weeks
- Conditions
- Lung Cancer, Pain
- Being tested
- fentanyl matrix
- Keywords
- fentanyl matrix
- Medical subject headings
- Lung Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fentanyl matrixDrug
Fentanyl transdermal patch 12 - 25mcg/hr
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | fentanyl matrix Fentanyl transdermal patch 12 - 25mcg/hr can increase with 12 - 25mcg/h based on pain assessment Receives: Drug: fentanyl matrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's satisfaction with pain treatment as measured by 5-point verbal scale
Measured: Day 1, 8 and 22
Secondary outcomes (4)
Difference in pain intensity measured by Numeric Rating Scale before and after treatment of the study drug measured
Measured: Day 1 (visit 1) and 22 (visit 3)
Detailed reasons for patient's satisfaction with the pain treatment
Measured: Day 22 (visit 3)
Patient's and investigator's satisfaction measured by 5-point verbal scale with the study drug
Measured: Day 22 (visit 3)
Dose of fentanyl matrix
Measured: Day 1 (visit 1), 8 (visit 2) and 22 (visit 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2010 (estimated)
- Study startMay 2006
- Primary completionMay 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Korea, Ltd., Korea
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Janssen Korea, Ltd. Clinical Trial, Study director, Janssen Korea, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01060137
- Sponsor's protocol ID
- CR012259
- Status last verified
- Feb 2010
- First submitted
- 29 Jan 2010
- Last updated
- 5 Feb 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Usefulness of DurogesicD-TRANS for Pain Treatment in Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT01060137
- Acronym / sponsor ID
- CR012259
- Conditions
- Lung Cancer, Pain
- Keywords
- fentanyl matrix
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 268 participants (actual)
- Lead sponsor
- Janssen Korea, Ltd., KoreaIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 2 Feb 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 evaluate the usefulness of fentanyl matrix by assessing patients' satisfaction when administrating fentanyl matrix, a background pain treatment, and a breakthrough pain treatment to lung cancer patients who complain of pain. Fentanyl matrix is designed to deliver medication at a nearly constant amount per unit time into the body through the skin for 3 days (72 hours).
Detailed description
This study is open-label, single-arm, multicenter, prospective study to evaluate the usefulness of fentanyl matrix (fentanyl transdermal patch-type system) by assessing patient satisfaction when administrating fentanyl matrix (a background pain treatment, and a breakthrough pain treatment) for patients with lung cancer for 21 days. Fentanyl transdermal patch-type system is designed to deliver medication at a nearly constant amount per unit time into the body through the skin for 3 days (72 hours). Studies about transdermal fentanyl have found that it had analgesic effects on malignant pain, and most patients receiving the medication preferred fentanyl because they experienced less constipation. Safety assessments will include adverse event monitoring, vital signs, laboratory work. starting with 12.5g/h or 25g/h of fentanyl matrix transdermally at the investigator's discretion and flexible dose depending the patient's pain relief for 3 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Drug: fentanyl matrixfentanyl matrix Fentanyl transdermal patch 12 - 25mcg/hr can increase with 12 - 25mcg/h based on pain assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with histologically confirmed lung cancer, who complain of cancer pain
- Patients who are taking Ultracet, Tramadol, or Codeine (or Codeine combination drug) for cancer pain-relief purposes, but still complain of a pain level of 4 or above on the Numeric Rating Scale (NRS) during the past 24 hours: Ultracet 3 tablets/day, Tramadol 150 mg/day, Codeine 200 mg /day, or Codeine combination less than 3 capsules/day
- Patients who are able to communicate with the investigator about his/her pain
- Patients who use proper contraceptives during the study period if they are women of childbearing potential
- Patients whose life expectancy is 3 months or longer
Key exclusion criteria (7 listed)
- Patients participating in other clinical trials
- Patients with a history of hypersensitivity to opioid analgesics
- Patients with a history of drug abuse
- Patients who are unable to use a transdermal product due to skin disease
- Patient with a history of CO2 retention (e.g. chronic obstructive pulmonary disease)
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 matrixFentanyl transdermal patch 12 - 25mcg/hr | Drug | 001 |
Primary outcome
Patient's satisfaction with pain treatment as measured by 5-point verbal scale
Time frame: Day 1, 8 and 22
4 secondary outcomes
Difference in pain intensity measured by Numeric Rating Scale before and after treatment of the study drug measured
Time frame: Day 1 (visit 1) and 22 (visit 3)
Detailed reasons for patient's satisfaction with the pain treatment
Time frame: Day 22 (visit 3)
Patient's and investigator's satisfaction measured by 5-point verbal scale with the study drug
Time frame: Day 22 (visit 3)
Dose of fentanyl matrix
Time frame: Day 1 (visit 1), 8 (visit 2) and 22 (visit 3)
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 5 Feb 2010.
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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?
A Phase 4 study testing fentanyl matrix in people with Lung Cancer and 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 6 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 5 Feb 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?
Patient's satisfaction with pain treatment as measured by 5-point verbal scale (time frame: Day 1, 8 and 22). 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 5 Feb 2010.