Chronic PainPhase 4NCT01902524
Efficacy and Safety Study of Fentanyl Transdermal Patch for Treatment of Chronic Pain
A Phase 4 study testing Fentanyl-TTS in people with Chronic Pain, run by Janssen Korea, Ltd., Korea at 1 site in South Korea.
Trial summary
The purpose of this study is to confirm effectiveness and safety of fentanyl transdermal patch Durogesic® D-Trans for treatment of chronic pain in participants with chronic non-cancer pain. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Fentanyl-TTS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2005to Nov 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
- spine related and extremity pain lasting for 3 months or longer
- pain with Numeric Rating Scale (NRS) at 4 or higher in the past 72 hours
- good overall health condition based on the medical history and clinical laboratory tests
- participants using appropriate contraception in case of childbearing potential during the study period.
Who cannot join
- history of hypersensitive reaction to narcotic analgesics
- history of narcotic abuse
- serious psychotic disorder
- unable to use transdermal analgesics due to a dermatological condition
- history of CO2 retention (e.g., chronic obstructive pulmonary disease)
- surgery in the area with pain within 7 days prior to initiation of the clinical study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation in Efficacy and Safety of Fentanyl-TTS (Durogesic® D-Trans) for Treatment of Chronic Pain
The purpose of this study is to confirm effectiveness and safety of fentanyl transdermal patch Durogesic® D-Trans for treatment of chronic pain in participants with chronic non-cancer pain.
Read the detailed description
This trial is a Phase 4, prospective, open-label (meaning that both the research physician and study participants will know which medication is being administered) study of fentanyl transdermal patch-type system (TTS) Durogesic® D-Trans in patients with non-cancer pain. The patch is designed to systematically release the adsorbed fentanyl percutaneously, in a constant rate for three days (72 hours). The study will be conducted for 12 weeks. The efficacy and safety will be evaluated at week 1, week 4, week 8 and week 12 visits. All participants will use the patch at least once during the study. The drug efficacy will be evaluated by the percent change in pain intensity before and after treatment and by improvements in the following activities: daily life, walking, meal intake, mood regulation. The overall safety will be assessed based on the adverse events reporting.
- Conditions
- Chronic Pain
- Being tested
- Fentanyl-TTS
- Keywords
- Chronic Pain, Fentanyl-TTS, Fentanyl Patch, Transdermal, Non-cancer Pain
- 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-TTSDrug
Also called fentanyl
All of the participants will receive the study drug at least once transdermally, administration dosage starts at 12.5 microgram/hour.
| Study group | Role | What they receive |
|---|---|---|
| Fentanyl-TTS | Experimental | Study drug administered in a form of one patch, either 21.0 cm2 or 10.5 cm2. Receives: Drug: Fentanyl-TTS |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in pain intensity
The percent change in Pain Intensity Difference (PID) after study treatment (Week 12) compared to Day 0, prior to study treatment.
Measured: Baseline, 12 weeks
Secondary outcomes (5)
Daily dose of prescribed medication
Change in daily dose of study medication prescribed at Day 0 and after 1, 4, 8 weeks.
Measured: 12 weeks
Change in functionality
Satisfaction in functionality by participants evaluated at day 0 and after 1, 4, 8 and 12 weeks of treatment, measured as improvements in change of scores from 0 (not disturbing) to 10 (completely disturbing).
Measured: 12 weeks
Change in sleep
Change in the frequency of waking up due to pain during the sleep.
Measured: 12 weeks
Satisfaction in study medication
Satisfaction in study medication by participants and investigators summarized at Week 4, 8 and 12 visits.
Measured: 12 weeks
The number of participants reporting adverse events (AEs)
All AEs during the study period will be reported.
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 posted18 Jul 2013 (estimated)
- Study startOct 2005
- Primary completionNov 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 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 Trials, Study director, Janssen Korea, Ltd., Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01902524
- Sponsor's protocol ID
- CR002155
- Other IDs
- FEN-KOR-10
- Status last verified
- Aug 2014
- First submitted
- 15 Jul 2013
- Last updated
- 28 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Park JH, Kim JH, Yun SC, Roh SW, Rhim SC, Kim CJ, Jeon SR. Evaluation of efficacy and safety of fentanyl transdermal patch (Durogesic D-TRANS) in chronic pain. Acta Neurochir (Wien). 2011 Jan;153(1):181-90. doi: 10.1007/s00701-010-0785-4. Epub 2010 Sep 7.
PubMed 20821238
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation in Efficacy and Safety of Fentanyl-TTS (Durogesic® D-Trans) for Treatment of Chronic Pain
- ClinicalTrials.gov ID
- NCT01902524
- Acronym / sponsor ID
- CR002155
- Conditions
- Chronic Pain
- Keywords
- Chronic Pain, Fentanyl-TTS, Fentanyl Patch, Transdermal, Non-cancer Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Janssen Korea, Ltd., KoreaIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 18 Jul 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 confirm effectiveness and safety of fentanyl transdermal patch Durogesic® D-Trans for treatment of chronic pain in participants with chronic non-cancer pain.
Detailed description
This trial is a Phase 4, prospective, open-label (meaning that both the research physician and study participants will know which medication is being administered) study of fentanyl transdermal patch-type system (TTS) Durogesic® D-Trans in patients with non-cancer pain. The patch is designed to systematically release the adsorbed fentanyl percutaneously, in a constant rate for three days (72 hours). The study will be conducted for 12 weeks. The efficacy and safety will be evaluated at week 1, week 4, week 8 and week 12 visits. All participants will use the patch at least once during the study. The drug efficacy will be evaluated by the percent change in pain intensity before and after treatment and by improvements in the following activities: daily life, walking, meal intake, mood regulation. The overall safety will be assessed based on the adverse events reporting.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fentanyl-TTS | Experimental | Drug: Fentanyl-TTSStudy drug administered in a form of one patch, either 21.0 cm2 or 10.5 cm2. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- spine related and extremity pain lasting for 3 months or longer
- pain with Numeric Rating Scale (NRS) at 4 or higher in the past 72 hours
- good overall health condition based on the medical history and clinical laboratory tests
- participants using appropriate contraception in case of childbearing potential during the study period.
Key exclusion criteria (6 listed)
- history of hypersensitive reaction to narcotic analgesics
- history of narcotic abuse
- serious psychotic disorder
- unable to use transdermal analgesics due to a dermatological condition
- 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-TTSAlso: fentanylAll of the participants will receive the study drug at least once transdermally, administration dosage starts at 12.5 microgram/hour. | Drug | Fentanyl-TTS |
Primary outcome
The change in pain intensity
Time frame: Baseline, 12 weeks
The percent change in Pain Intensity Difference (PID) after study treatment (Week 12) compared to Day 0, prior to study treatment.
5 secondary outcomes
Daily dose of prescribed medication
Time frame: 12 weeks
Change in functionality
Time frame: 12 weeks
Change in sleep
Time frame: 12 weeks
Satisfaction in study medication
Time frame: 12 weeks
The number of participants reporting adverse events (AEs)
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 28 Aug 2014.
- Results publication: PubMed 20821238Park JH, Kim JH, Yun SC, Roh SW, Rhim SC, Kim CJ, Jeon SR. Evaluation of efficacy and safety of fentanyl transdermal patch (Durogesic D-TRANS) in chronic pain. Acta Neurochir (Wien). 2011 Jan;153(1):181-90. doi: 10.1007/s00701-010-0785-4. Epub 2010 Sep 7.
- Evaluation in Efficacy and Safety of Fentanyl-TTS (Durogesic® D-Trans) for Treatment of Chronic PainLink provided by the sponsor.
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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 Trials study director
Janssen Korea, Ltd., Korea
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 Fentanyl-TTS in people with Chronic Pain, run by Janssen Korea, Ltd., Korea at 1 site 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 4 inclusion and 6 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 Aug 2014. 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 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.
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?
The change in pain intensity (time frame: Baseline, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01902524, which also lists 1 linked publication.
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 Aug 2014.