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Also known as Fentanyl 1-day transdermal patch (Titration Phase)
Fentanyl 1-day patch · 1 trial · 2 indications
Participants achieving dose titration success included all participants who had a mean Visual Analog Scale (VAS) score of less than or equal to 34 millimeter (mm) and received not more than 2 rescue doses during the last 3 days before the completion or discontinuation of dose titration phase. Pain Intensity VAS measured severity of pain on a 100 mm scale ranging from 0 mm (no pain) to 100 mm (severest pain conceivable) and rescue dose was defined as dose of a fast-acting oral morphine hydrochloride solution or morphine in water solution used in the case of breakthrough pain.
The mean VAS score for the last 3 days before the completion or discontinuation of Double Blind Phase was compared with that for the last 3 days before the completion or discontinuation of Dose Titration Phase and the change from Dose Titration Phase in the mean VAS Score at Double Blind Phase was reported. Pain Intensity VAS measured severity of pain on a 100 mm scale ranging from 0 mm (no pain) to 100 mm (severest pain conceivable).
| Arm | Type | Description |
|---|---|---|
| Fentanyl 1-day transdermal patch (Titration Phase) | EXPERIMENTAL | Fentanyl 1-day application transdermal patch releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) applied once daily, and maintained for 2 days. Dose escalation or reduction is done as per Investigator's discretion (maximum applied dose is 100 mcg/hr) up to Day 11 and then dose is fixed up to end of treatment period, that is Day 14. Participants who met the predefined criteria at the end of Titration Phase enter the Double Blind Phase. |
| Fentanyl 1-day transdermal patch (Double Blind Phase) | EXPERIMENTAL | Participants who meet the predefined criteria at the end of Titration Phase and enter the Double Blind Phase receive fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application (JNS005) transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days. |
| Fentanyl 3-day transdermal patch (Double Blind Phase) | ACTIVE_COMPARATOR | Participants who meet the predefined criteria at the end of Titration Phase and enter the Double Blind Phase receive fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days. |
| Name | Type | Description |
|---|---|---|
| Fentanyl 1-day transdermal patch (Titration Phase) | DRUG | Fentanyl 1-day application transdermal patch releasing the drug at the rate of 12.5 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction is done as per Investigator's discretion (maximum applied dose is 100 mcg/hr) up to Day 11 and then dose is fixed up to end of treatment period, that is Day 14. |
| Fentanyl 1-day transdermal patch (Double Blind Phase) | DRUG | Fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days. |
| Fentanyl 3-day transdermal patch (Double Blind Phase) | DRUG | Fentanyl 3-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days. |
| Placebo | DRUG | Placebo matching to fentanyl 3-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase for 10 days. |
Inclusion Criteria: * Participants with cancer pain who were previously not treated with opioid analgesics (drug used to control pain) * Participants with a pain score of greater than or equal to 35 millimeter (mm) on a 100-mm visual analog scale (VAS) * Participants who are considered to have "ins...
The fentanyl 1-day patch is an investigational transdermal formulation of fentanyl, a small-molecule opioid agonist, designed to deliver pain relief over a single day. Johnson & Johnson (ticker JNJ) developed it under the code JNS020 QD for cancer pain. It is also known as the fentanyl 1-day transdermal patch (Titration Phase).
The fentanyl 1-day patch was studied for the treatment of cancer pain in participants with Pain and Cancer. The single Phase 2 trial enrolled adults aged 20 years and older in Japan. It is not approved and remains an investigational asset rather than a marketed product.
The fentanyl 1-day patch targets OPRM1, the mu-opioid receptor, and acts as an agonist at that receptor. Fentanyl is a small molecule, and binding at OPRM1 produces the analgesic effect the patch was being developed to deliver in cancer pain.
Johnson & Johnson, which trades under the ticker JNJ, developed the fentanyl 1-day patch. The company ran the program under the designation JNS020 QD. No other developer or partner is associated with this asset.
The fentanyl 1-day patch is in Phase 2 development. Its only recorded trial, NCT00644787, is a completed Phase 2 dose-finding study. There are no active trials, and the asset is investigational rather than FDA approved.
The fentanyl 1-day patch has been studied in one clinical trial, NCT00644787, titled A Dose-Finding Study of Fentanyl (JNS020 QD) 1-Day Transdermal Patch in Participants With Cancer Pain. That Phase 2 trial is completed, was randomized, double-blind, and active-controlled, and enrolled 156 participants in Japan.