PainPhase 4NCT00523887
Fentanyl for Treatment Pain Caused by Radiotherapy
A Phase 4 study testing Fentanyl transdermal therapeutic system in people with Pain, run by Johnson & Johnson Taiwan Ltd.
Trial summary
The purpose of this study is to assess the clinical utility and safety of Fentanyl for pain treatment caused by radiotherapy. Fentanyl is a synthetic pure opioid agonist with a selective activity on µ receptors. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Fentanyl transdermal therapeutic system
- How many people
- 163 participants
- Where
- No sites listed yet
- Study dates
- Aug 2005to Sep 2006
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients have the history of head and neck tumor
- Patients who are proceeding radiotherapy
- Patients who are administered weak opioids and pain score (Visual analog scale) of 4
Who cannot join
- Patients who have been administered Fentanyl for pain treatment within 2 weeks before the study
- Patients who will have surgery within 1 month
- Known presence of distant metastasis
About this study
Official title: Post-Marketing Surveillance of Durogesic for Treatment Pain Caused by Radiotherapy
The purpose of this study is to assess the clinical utility and safety of Fentanyl for pain treatment caused by radiotherapy. Fentanyl is a synthetic pure opioid agonist with a selective activity on µ receptors.
Read the detailed description
The study is a phase IV, open label, single arm study. The purpose of this study is to assess the clinical utility and safety of fentanyl transdermal therapeutic system (patch) for treatment of pain caused by radiotherapy. The patients increase or even decrease the amount of study medication in order to achieve pain relief, 48 to 72 hours or 3 days are required after the first patch application. The study medication will be used for 4 weeks. VAS (visual analog scale), BPI Q9 (quality of life) and global assessment have been used to assess the effectiveness. VAS will be assessed every week. BPI Q9 will be assessed at week 1 and week 4. Global assessment will be assessed at week 4. The safety of the study drug will be evaluated using adverse event (AE) report.
The investigator will assess the pain intensity of patients and increase or even decrease Fentanyl dosage every week. Fentanyl will be started on 25 or 50 ug per hr depending on investigator's judgement. Fentanyl will be administered for 4 weeks.
- Conditions
- Pain
- Being tested
- Fentanyl transdermal therapeutic system
- Keywords
- Radiation pain, Duragesic, Fentanyl, Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl transdermal therapeutic systemDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the clinical utility of Fentanyl transdermal therapeutic system for pain treatment caused by radiotherapy. VAS (at week 1~4), BPI Q9 (week 1 and 4) and global assessment (week 4) have been used to assess the clinical utility.
Secondary outcomes (1)
To evaluate the safety of Fentanyl transdermal therapeutic system for pain treatment caused by radiotherapy using AE (adverse event) report at every visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2007 (estimated)
- Study startAug 2005
- Study completionSep 2006
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Taiwan Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Johnson & Johnson Taiwan, Ltd. Clinical Trial, Study director, Johnson & Johnson Taiwan Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00523887
- Sponsor's protocol ID
- CR013990
- Status last verified
- Apr 2010
- First submitted
- 30 Aug 2007
- Last updated
- 28 Apr 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Marketing Surveillance of Durogesic for Treatment Pain Caused by Radiotherapy
- ClinicalTrials.gov ID
- NCT00523887
- Acronym / sponsor ID
- CR013990
- Conditions
- Pain
- Keywords
- Radiation pain, Duragesic, Fentanyl, Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Johnson & Johnson Taiwan LtdIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- Study completion
- Sep 2006 (actual)
- First posted
- 3 Sep 2007 (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 clinical utility and safety of Fentanyl for pain treatment caused by radiotherapy. Fentanyl is a synthetic pure opioid agonist with a selective activity on µ receptors.
Detailed description
The study is a phase IV, open label, single arm study. The purpose of this study is to assess the clinical utility and safety of fentanyl transdermal therapeutic system (patch) for treatment of pain caused by radiotherapy. The patients increase or even decrease the amount of study medication in order to achieve pain relief, 48 to 72 hours or 3 days are required after the first patch application. The study medication will be used for 4 weeks. VAS (visual analog scale), BPI Q9 (quality of life) and global assessment have been used to assess the effectiveness. VAS will be assessed every week. BPI Q9 will be assessed at week 1 and week 4. Global assessment will be assessed at week 4. The safety of the study drug will be evaluated using adverse event (AE) report.
The investigator will assess the pain intensity of patients and increase or even decrease Fentanyl dosage every week. Fentanyl will be started on 25 or 50 ug per hr depending on investigator's judgement. Fentanyl will be administered for 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients have the history of head and neck tumor
- Patients who are proceeding radiotherapy
- Patients who are administered weak opioids and pain score (Visual analog scale) of 4
Key exclusion criteria (3 listed)
- Patients who have been administered Fentanyl for pain treatment within 2 weeks before the study
- Patients who will have surgery within 1 month
- Known presence of distant metastasis
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 transdermal therapeutic system | Drug | – |
Primary outcome
To evaluate the clinical utility of Fentanyl transdermal therapeutic system for pain treatment caused by radiotherapy. VAS (at week 1~4), BPI Q9 (week 1 and 4) and global assessment (week 4) have been used to assess the clinical utility.
1 secondary outcome
To evaluate the safety of Fentanyl transdermal therapeutic system for pain treatment caused by radiotherapy using AE (adverse event) report at every visit.
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 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.
Johnson & Johnson Taiwan, Ltd. Clinical Trial study director
Johnson & Johnson Taiwan Ltd
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fentanyl transdermal therapeutic system in people with Pain, run by Johnson & Johnson Taiwan Ltd.
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 3 inclusion and 3 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 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?
To evaluate the clinical utility of Fentanyl transdermal therapeutic system for pain treatment caused by radiotherapy. VAS (at week 1~4), BPI Q9 (week 1 and 4) and global assessment (week 4) have been used to assess the clinical utility.. 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 2010.