Cancer, PainPhase 4NCT00771199
An Efficacy and Safety Study of Low-dose Transdermal Therapeutic System (TTS)-Fentanyl D-Trans in Taiwan Participants With Cancer Pain
A Phase 4 study testing Transdermal Therapeutic System (TTS)-Fentanyl in people with Cancer, Pain, run by Janssen-Cilag Ltd. at 1 site in United Kingdom.
Trial summary
The purpose of this study is to evaluate safety/tolerability and clinical utility of low-dose transdermal therapeutic system (TTS [medicated adhesive pad that is placed on the skin to deliver a timed-release dose of medication through the skin into the bloodstream]) - fentanyl in Taiwan participants with cancer pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Pain
- What is being tested?
- Transdermal Therapeutic System (TTS)-Fentanyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2008to 26 Nov 2008
- 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
- Participants diagnosed with cancer; histologically (examination of tissue specimens under a microscope) confirmed malignancy (term for diseases in which abnormal cells divide without control and can invade nearby tissues)
- Participants who are able to communicate effectively with study personnel
- Participants who have intolerable cancer pain (pain score greater than or equal to [>=] 4)
- Participants who have an estimated life expectancy of at least 30 days
- Participants who have given written dated informed consent to participate in the study
Who cannot join
- Participants who have already received regular treatment with an strong opioid (morphine-like synthetic narcotic that produces the same effects as drugs derived from the opium poppy [opiates]), for their pain before entering the study
- Participants who have already received tramadol (a narcotic-like pain reliever used to treat moderate to severe pain) treatment over 200 milligram (mg) for their pain before entering the study
- Participants with significant abnormalities in hepatic or renal function which would, in the opinion of the Investigator, prevent the participants involvement in the study
- Participants with significant clinical abnormalities in central nervous system (CNS), respiratory or cardiovascular function, which in the investigators judgment prevents participation in the study
- Pregnant or lactating females or females of child bearing potential not currently practicing documented, adequate contraception
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Multicenter Study to Evaluate the Safety/Tolerability and Clinical Utility of Low-dose TTS-Fentanyl D-TRANS in Taiwan Patients With Cancer Pain
The purpose of this study is to evaluate safety/tolerability and clinical utility of low-dose transdermal therapeutic system (TTS [medicated adhesive pad that is placed on the skin to deliver a timed-release dose of medication through the skin into the bloodstream]) - fentanyl in Taiwan participants with cancer pain. Secondly, to demonstrate the dropout rate that will be decreased by initiating therapy with12 microgram per hour (mcg/hr) instead of with 25 mcg/h.
Read the detailed description
This is an open-label (all people know the identity of the intervention), multi-center (when more than one hospital or medical school team work on a medical research study), single-arm, non-randomized study to evaluate the efficacy and safety of low-dose TTS-fentanyl in Taiwan participants with cancer pain. Eligible participants will be enrolled and scheduled to return at Day 0, 7, 14 and 28. Participants will receive TTS-fentanyl for 28 days at a starting dose of 12 micrograms per hour (mcg/h) (one patch). Dose of fentanyl can increased or decreased as per Investigator's discretion to maintain participant's pain score at 2 or less on the Brief Pain Inventory (BPI) question 6 (that tells how much pain you have right now). Safety will primarily be evaluated by measuring participant's dropout rate due to adverse events. Participants' safety will be monitored throughout the study.
- Conditions
- Cancer, Pain
- Being tested
- Transdermal Therapeutic System (TTS)-Fentanyl
- Keywords
- Cancer pain, Pain, Fentanyl, Durogesic, Cancer, Transdermal
- Medical subject headings
- Cancer Pain, Pain, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transdermal Therapeutic System (TTS)-FentanylDrug
Participants will receive 1 transdermal patch of TTS-fentanyl containing 12 micrograms per hour (mcg/h) for 28 days. Dose can be increased or decreased as per Investigator's discretion up to 100 mcg/h.
| Study group | Role | What they receive |
|---|---|---|
| Transdermal Therapeutic System (TTS)-Fentanyl | Experimental | Not described Receives: Drug: Transdermal Therapeutic System (TTS)-Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Dropped From Study due to Adverse Events
An adverse event is any untoward medical occurrence in a clinical study participant administered a pharmaceutical product. An adverse event does not necessarily have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. Percentage of participants who will be prematurely withdrawn from the study due to any adverse events will be reported.
Measured: Day 0 up to Day 28
Secondary outcomes (5)
Brief Pain Inventory (BPI) Score (Question 6)
The BPI question number 6 describes pain severity, will be measured by the daily pain diary on numeric rating scale (NRS), ranging from 1 to 10; where 0 signifies no pain and 10 signifies extreme pain.
Measured: Day 0, Day 7, Day 14 and Day 28
BPI Score (Question 9) - Quality of Life (QOL)
Participant's quality of life (QOL) will be assessed by BPI question number 9 (items 9a to 9g), which describes "how during the past 24 hours pain has interfered with participants general activity, mood, walking ability, normal work, relation with other people, sleep, enjoyment of life". Each item will be measured on NRS, ranges from 1 to 10 where 0 signifies does not interfere and 10 signifies completely interferes. Total score is the average of scores of all items and ranges from 0 to 10, where higher scores signifies higher pain/interference.
Measured: Day 0, Day 7, Day 14 and Day 28
Average Daily Dose and Final Dose of Transdermal Therapeutic System (TTS)-fentanyl
The TTS-fentanyl dosage is only increased in consultation with the treating physician and according to the participant's analgesic requirements, with the intention of maintaining his/ her pain score at 2 or less on the BPI question 6.
Measured: Day 0 up to Day 28
Investigator's Global Assessment Scale Score
Investigator will complete a global assessment of the participants treatment with respect to pain control using 4-point scale, where 1 signifies poor, 2 signifies fair, 3 signifies good, 4 signifies very good.
Measured: Day 0 and Day 28
Percentage of Participants With Treatment Satisfaction
Participants will rate their assessment of treatment satisfaction, using 4-point scale where 1 signifies poor, 2 signifies fair, 3 signifies good and 4 signifies very good.
Measured: Day 0 and Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2008 (estimated)
- Study start1 Oct 2008
- Primary completion26 Nov 2008
- Study completion26 Nov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer, 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag Ltd Clinical Trial, Study director, Janssen-Cilag Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00771199
- Sponsor's protocol ID
- CR014602
- Other IDs
- FENPAI4054
- Status last verified
- Jun 2026
- First submitted
- 10 Oct 2008
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter Study to Evaluate the Safety/Tolerability and Clinical Utility of Low-dose TTS-Fentanyl D-TRANS in Taiwan Patients With Cancer Pain
- ClinicalTrials.gov ID
- NCT00771199
- Acronym / sponsor ID
- CR014602
- Conditions
- Cancer, Pain
- Keywords
- Cancer pain, Pain, Fentanyl, Durogesic, Cancer, Transdermal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Janssen-Cilag Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2008 (actual)
- Primary completion
- 26 Nov 2008 (actual)
- Study completion
- 26 Nov 2008 (actual)
- First posted
- 13 Oct 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 study is to evaluate safety/tolerability and clinical utility of low-dose transdermal therapeutic system (TTS [medicated adhesive pad that is placed on the skin to deliver a timed-release dose of medication through the skin into the bloodstream]) - fentanyl in Taiwan participants with cancer pain. Secondly, to demonstrate the dropout rate that will be decreased by initiating therapy with12 microgram per hour (mcg/hr) instead of with 25 mcg/h.
Detailed description
This is an open-label (all people know the identity of the intervention), multi-center (when more than one hospital or medical school team work on a medical research study), single-arm, non-randomized study to evaluate the efficacy and safety of low-dose TTS-fentanyl in Taiwan participants with cancer pain. Eligible participants will be enrolled and scheduled to return at Day 0, 7, 14 and 28. Participants will receive TTS-fentanyl for 28 days at a starting dose of 12 micrograms per hour (mcg/h) (one patch). Dose of fentanyl can increased or decreased as per Investigator's discretion to maintain participant's pain score at 2 or less on the Brief Pain Inventory (BPI) question 6 (that tells how much pain you have right now). Safety will primarily be evaluated by measuring participant's dropout rate due to adverse events. Participants' safety will be monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transdermal Therapeutic System (TTS)-Fentanyl | Experimental | Drug: Transdermal Therapeutic System (TTS)-Fentanyl |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants diagnosed with cancer; histologically (examination of tissue specimens under a microscope) confirmed malignancy (term for diseases in which abnormal cells divide without control and can invade nearby tissues)
- Participants who are able to communicate effectively with study personnel
- Participants who have intolerable cancer pain (pain score greater than or equal to [>=] 4)
- Participants who have an estimated life expectancy of at least 30 days
- Participants who have given written dated informed consent to participate in the study
Key exclusion criteria (5 listed)
- Participants who have already received regular treatment with an strong opioid (morphine-like synthetic narcotic that produces the same effects as drugs derived from the opium poppy [opiates]), for their pain before entering the study
- Participants who have already received tramadol (a narcotic-like pain reliever used to treat moderate to severe pain) treatment over 200 milligram (mg) for their pain before entering the study
- Participants with significant abnormalities in hepatic or renal function which would, in the opinion of the Investigator, prevent the participants involvement in the study
- Participants with significant clinical abnormalities in central nervous system (CNS), respiratory or cardiovascular function, which in the investigators judgment prevents participation in the study
- Pregnant or lactating females or females of child bearing potential not currently practicing documented, adequate contraception
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 |
|---|---|---|
| Transdermal Therapeutic System (TTS)-FentanylParticipants will receive 1 transdermal patch of TTS-fentanyl containing 12 micrograms per hour (mcg/h) for 28 days. Dose can be increased or decreased as per Investigator's discretion up to 100 mcg/h. | Drug | Transdermal Therapeutic System (TTS)-Fentanyl |
Primary outcome
Percentage of Participants Dropped From Study due to Adverse Events
Time frame: Day 0 up to Day 28
An adverse event is any untoward medical occurrence in a clinical study participant administered a pharmaceutical product. An adverse event does not necessarily have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. Percentage of participants who will be prematurely withdrawn from the study due to any adverse events will be reported.
5 secondary outcomes
Brief Pain Inventory (BPI) Score (Question 6)
Time frame: Day 0, Day 7, Day 14 and Day 28
BPI Score (Question 9) - Quality of Life (QOL)
Time frame: Day 0, Day 7, Day 14 and Day 28
Average Daily Dose and Final Dose of Transdermal Therapeutic System (TTS)-fentanyl
Time frame: Day 0 up to Day 28
Investigator's Global Assessment Scale Score
Time frame: Day 0 and Day 28
Percentage of Participants With Treatment Satisfaction
Time frame: Day 0 and Day 28
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 4 Jun 2026.
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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-Cilag Ltd Clinical Trial study director
Janssen-Cilag Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Transdermal Therapeutic System (TTS)-Fentanyl in people with Cancer, Pain, run by Janssen-Cilag Ltd. at 1 site in United Kingdom.
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 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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.
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?
Percentage of Participants Dropped From Study due to Adverse Events (time frame: Day 0 up to Day 28). 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 4 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.