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| ID | Type | Description | Link |
|---|---|---|---|
| FEN-KOR-10 | Other Identifier | Janssen Korea, Ltd., Korea |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fentanyl-TTS | Experimental | Study drug administered in a form of one patch, either 21.0 cm2 or 10.5 cm2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fentanyl-TTS | Drug | All of the participants will receive the study drug at least once transdermally, administration dosage starts at 12.5 microgram/hour. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Daily dose of prescribed medication | Change in daily dose of study medication prescribed at Day 0 and after 1, 4, 8 weeks. | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Korea, Ltd., Korea Clinical Trials | Janssen Korea, Ltd., Korea | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | 140-702 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20821238 | Result | 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. |
| Label | URL |
|---|---|
| Evaluation in Efficacy and Safety of Fentanyl-TTS (Durogesic® D-Trans) for Treatment of Chronic Pain | View source |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| 12 weeks |
| Change in sleep | Change in the frequency of waking up due to pain during the sleep. | 12 weeks |
| Satisfaction in study medication | Satisfaction in study medication by participants and investigators summarized at Week 4, 8 and 12 visits. | 12 weeks |
| The number of participants reporting adverse events (AEs) | All AEs during the study period will be reported. | 12 weeks |