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Also known as JNS020QD, Fentanyl-TTS
Fentanyl · 7 trials · 9 indications
Criteria for maintenance of adequate analgesia is defined as: 1) The daily dose of the study drug is constant during the 7 days in the maintenance period before completion of the maintenance period; 2) Change in Visual Analogue Scale (VAS) mean values from baseline to endpoint is ≤+15 mm; 3) Frequency of daily rescue doses during the 7 days in the maintenance period is ≤ 2 doses, and the change in the mean frequency of daily rescue dose from the baseline to endpoint is ≤+1.0 dose.
Time from start of double-blind (researchers and participants were unaware of the treatment) period to withdrawal because of insufficient analgesic efficacy based on any of the pre-defined discontinuation criteria was noted.
Questionnaire of opioid withdrawal symptoms is a clinician rated 11-item scale that primarily evaluates the physical components of opioid withdrawal and is based on questions and clinical observations. The total score of questionnaire of opioid withdrawal symptoms is the sum of all individual items, with less than (\<) 5 points = no withdrawal, 5 to 12 points = mild withdrawal, 13 to 24 points = moderate withdrawal, 25 to 36 points = moderately severe withdrawal and greater than (\>) 36 points = severe withdrawal.
The DQ is a clinician rated 5-item scale that evaluates dependence on drug and based on questions (Q). Based on participant's answer to Q in questionnaire, Investigator assessed whether drug dependence occurred. It comprises 5 Q which are: continuing drug for reason other than pain, using drug in more dosage than prescribed to have effect other than treatment of pain, have ever used drug with more dosage than prescribed for other purpose, anxiety with the thought of stopping drug for reason other than aggravation of symptoms by stopping this drug and feeling to violate law to get this drug.
Pain visual analog scale was used to assess the amount of pain experienced by the participant throughout the day by marking a slash through the line of a 100 millimeter (mm) scale measuring pain from "no pain (0 mm)" to "worst possible pain (100 mm)".
Pain intensity was measured by assessing the average intensity of pain experienced by the participant in daily living throughout the day by 4 grades: no pain at all, mild (slightly painful, but not worried), moderate (painful, but bearable) and severe (painful and unbearable).
The participants assessed total painful time in 1 day by the following 5 grades: less than 4 hours, 4 hours to less than 8 hours, 8 hours to less than 12 hours, 12 hours or more and all day.
The quality of sleep was assessed by participants that how well they have slept from the previous assessment to current assessment time by the following 4 grades: can sleep well, can sleep moderately well, cannot sleep much and cannot sleep at all.
Rescue treatment was used for participants with lack of analgesic efficacy, to have relief from breakthrough pain and in cases where withdrawal symptoms occur. The reference one-time rescue dose used was oral morphine 5 milligram (mg) for the investigational product fentanyl one-day transdermal patch 12.5 mcg per hr. The number of rescue treatments per day were reported.
The SF-36 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both. All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state.
The treating physician assessed the therapeutic efficacy of the treatment by 2 grades: effective and ineffective. Numbers of participants with effective and ineffective therapeutic efficacy with the treatment were reported.
The participants assessed their satisfaction with therapeutic efficacy by 5 grades: satisfied very much, satisfied, equivocal, dissatisfied and dissatisfied very much. Percentage of participants who were at least satisfied (satisfied, satisfied very much) or at least neither satisfied nor dissatisfied (dissatisfied, dissatisfied very much) were reported.
The BPI-SF is a self-report questionnaire designed to assess the severity and impact of pain on daily functions. It includes pain interference score which is mean value for scores for 9 BPI-SF questions ranging between 0 (does not interfere) to 10 (completely interferes) and pain subscale score which is mean value for scores for BPI-SF questions 3 to 6 ranging between 0 (no pain) to 10 (pain as bad as can imagine). Total BPI-SF score is an average of pain interference score and pain subscale score and ranges from 0 to 10; higher score indicates more pain or pain interference.
Pain control was assessed based on change in Visual Analog Scale (VAS) and number of daily rescue doses during 3 days before completion of study drug from 3 days before start of study drug. For VAS score, a difference of less than or equal to +15 millimeter (mm) and for rescue doses, a difference of less than or equal to 1 was considered significant to achieve pain control. Pain Intensity VAS ranged from 0 mm (no pain) to 100 mm (severest pain conceivable) and rescue dose was defined as dose of fast-acting opioid analgesic (except fentanyl preparations) used for lack of analgesic effect.
| Arm | Type | Description |
|---|---|---|
| JNS020QD | EXPERIMENTAL | - |
| Fentanyl (Titration period) | EXPERIMENTAL | One-day adhesive transdermal patch containing fentanyl (JNS020QD) applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 microgram per hour (mcg/hr) for at least first 2 days, which will be increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and visual analog scale (VAS) score of the participants. The dose will be increased up to maximum of 50 mcg/hr. The treatment will be continued for 10-29 days and then the eligible participants from this group will be randomly assigned to either of the two groups in the double-blind period. |
| Fentanyl (Double-blind period) | EXPERIMENTAL | Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, will be administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which will be same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment will be continued for 12 weeks. |
| Placebo (Double-blind period) | PLACEBO_COMPARATOR | Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, will be administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) will be gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo will be gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment will continue for 12 weeks. |
| Fentanyl | EXPERIMENTAL | Fentanyl transdermal patch will be applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose will be increased as per Investigators' discretion in both treatment periods and the maximum applied dose will be 300 mcg/hr. Total duration of treatment is 52 weeks. |
| Name | Type | Description |
|---|---|---|
| JNS020QD | DRUG | During weeks 1-3, initial doses of 0.84 mg, 1.7 mg, 3.4 mg, or 5 mg can be increased until individual optimal dose (up to maximum 20.1 mg) is determined. The optimal dose will be administered during the maintenance period (1 week), followed by a long-term treatment (48 weeks) period, where the dose will be adjusted (escalated or reduced) in consideration of the efficacy of the study, and the condition of adverse events. The patches are applied on the skin and exchanged daily (every 24 hours) for consecutive 52 weeks. |
| Fentanyl | DRUG | One-day adhesive transdermal patch containing fentanyl 12.5 to 50 mcg/hr applied to chest, abdomen, upper arm or thigh and replaced every day. |
| Placebo | DRUG | Placebo patch indistinguishable from one-day adhesive transdermal patch containing fentanyl 12.5 to 50 mcg/hr applied to chest, abdomen, upper arm or thigh and replaced every day. |
Inclusion Criteria: * Chronic pain that requires opioid analgesics and that has persisted for 12 weeks or longer before giving the consent * Patients who received any of the following opioid analgesics at a stable dose for the treatment of chronic pain for 7 days or longer before giving the consent...
Top 4 of 15 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Eli Lilly and Company | LLY | 4 | PHASE3 | Retatrutide, LY3016859, LY3556050, LY3526318, LY3857210 |
| Fortress Biotech, Inc. | FBIO | 1 | PHASE3 | Tramadol |
| Merck & Co., Inc. | MRK | 1 | PHASE2 | MK-6916 |
| Creative Medical Technology Holdings, Inc. | CELZ | 1 | PHASE1 | CELZ-201-DDT |
Fentanyl is an opioid analgesic studied for the treatment of chronic pain, including osteoarthritis, low back pain, postherpetic neuralgia, complex regional pain syndrome, postoperative pain syndrome, and cancer pain. Johnson & Johnson has developed it in Phase 3 trials conducted in Japan in adults aged 20 years and older.
Fentanyl targets OPRM1, the mu-opioid receptor, where it acts as an agonist. Activation of this receptor produces analgesia and is the basis for its use in moderate to severe pain. The drug is a small molecule developed by Johnson & Johnson under the ticker JNJ.
Fentanyl is developed by Johnson & Johnson, which trades under the ticker JNJ. The company has run Phase 3 clinical development of the drug in Japan for chronic pain and related pain conditions, including osteoarthritis, low back pain, postherpetic neuralgia, and cancer pain.
Fentanyl is in Phase 3 clinical development for pain indications. It is investigational and has not been approved based on the development information available. Johnson & Johnson has completed Phase 3 studies of the drug in Japan, and no trials are currently listed as active.
Fentanyl has been studied in completed Phase 3 trials including NCT01008618 in osteoarthritis or low back pain, NCT01008553 in postherpetic neuralgia, complex regional pain syndrome, or postoperative pain syndrome, NCT00788372 in chronic pain, and NCT00641667 in cancer pain. All were conducted in Japan in adults aged 20 years and older.
The fentanyl Phase 3 trials were randomized, double-blind, and placebo-controlled, with enrollment ranging from 66 to 258 participants per study. They enrolled adults aged 20 years and older in Japan and covered chronic pain, osteoarthritis, low back pain, postherpetic neuralgia, complex regional pain syndrome, postoperative pain syndrome, and cancer pain.