A Phase 3 interventional study of Fentanyl in Chronic Pain, sponsored by Janssen Pharmaceutical K.K.. Completed at 23 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2013-06-26.
Sponsored by Janssen Pharmaceutical K.K. · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the safety and efficacy of fentanyl one-day transdermal patch (JNS020QD, patch containing a drug that is put on the skin so the drug will enter the body through the skin) in participants with chronic (lasting a long time) pain.
This is an open-label (all people know the identity of the intervention), multi-center (conducted in more than one center) and non-comparative study of fentanyl one-day transdermal patch. The study consists of 4 periods: Screening period (3-14 days), Treatment period 1 (4 weeks), Treatment period 2 (48 weeks), Tapering period (0-6 weeks) and Follow-up period (1 week). Treatment will be initiated at 12.5 microgram per hour (mcg/hr). In both Treatment period 1 and 2, the dose will be increased as per the Investigator's discretion, ranging from 12.5 mcg/hr to 100 mcg/hr and the maximum application dose will be 300 mcg/hr. However, in Treatment period 2, the dose will be increased on 7th day before the day of medical examination (only if the participant used rescue treatment for minimum of 3 times per day for minimum of 4 days). The patch will be applied on areas including the chest, abdomen, upper arm and femoral region and replaced daily. Efficacy will primarily be evaluated by visual analog scale (VAS) score. The total duration of the study treatment will be 52 weeks. Participants' safety will be monitored throughout the study.
2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.
This study's enrollment of 142 is above the median of 60 across 2,161 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →Janssen Pharmaceutical K.K. is the lead sponsor of 122 studies on the registry; none are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 6 (50%) have results posted.
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Exclusion Criteria:
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.
Drug: Fentanyl
Fentanyl transdermal patch will be applied daily starting at a dose of 12.5 mcg/hr, and up to 52 weeks. Dose will be increased as per Investigator's discretion.
Also known as: JNS020QD
Questionnaire of Opioid Withdrawal Symptoms
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.
Time frame: Week 52 or endpoint (1 week after last treatment or early discontinuation)
Dependence Questionnaire (DQ)
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.
Time frame: Week 52 or end point (early discontinuation)
Pain Visual Analogue Scale Score
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)".
Time frame: Week 52 or end point (early discontinuation)
Number of Participants With Pain Assessed by Categorical Scale for Pain
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).
Time frame: Week 52 or final evaluation (early discontinuation)
Number of Participants With Total Painful Time Per Day
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.
Time frame: Week 52 or final evaluation (early discontinuation)
Number of Participants With Quality of Sleep
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.
Time frame: Week 52 or final evaluation (early discontinuation)
Number of Rescue Treatments
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.
Time frame: Week 52 or final evaluation (early discontinuation)
Short-Form 36-Item Health Survey (SF-36) Scores
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.
Time frame: Week 52 or final evaluation (early discontinuation)
Physician's Global Assessment Scale
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.
Time frame: Week 52 or final evaluation (early discontinuation)
Participants Overall Assessment
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.
Time frame: Week 52 or final evaluation (early discontinuation)
Brief Pain Inventory-Short Form (BPI-SF) Total Score
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.
Time frame: Week 52 or final evaluation (early discontinuation)
| Milestone | Fentanyl |
|---|---|
| Started | 142 |
| Completed | 111 |
| Not completed | 31 |
| Withdrew: Adverse event | 18 |
| Withdrew: Ineligible for transfer to period 2 | 9 |
| Withdrew: Withdrawal of informed consent | 4 |
| Milestone | Fentanyl |
|---|---|
| Started | 111 |
| Completed | 79 |
| Not completed | 32 |
| Withdrew: Adverse event | 13 |
| Withdrew: Physician decision | 9 |
| Withdrew: Withdrawal of informed consent | 9 |
| Withdrew: Aggravated symptoms | 1 |
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.
| participants | Fentanyl |
|---|---|
| < 5 points | 137 |
| >=5 to <=12 points | 2 |
| >=13 to <=24 points | 1 |
| >=25 to <=36 points | 0 |
| >=37 points | 0 |
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.
| units on a scale | Fentanyl |
|---|---|
| Q1:Continue to use drug for reason other than pain | 1 |
| Q 2: Wanted to use more dosage than prescribed | 0 |
| Q3: Used drug with more dosage than prescribed | 0 |
| Q4: Anxious with thought of stopping drug | 1 |
| Q5: Feeling to violate law to get this drug | 0 |
| Judgment by doctor: Dependent and abuse | 0 |
| Judgement by doctor: Not dependent and no abuse | 140 |
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)".
| mm | Fentanyl |
|---|---|
| Pain Visual Analogue Scale Score | 58.3 ± 24.72 |
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).
| participants | Fentanyl |
|---|---|
| No pain | 1 |
| Mild pain | 21 |
| Moderate pain | 101 |
| Severe pain | 18 |
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.
| participants | Fentanyl |
|---|---|
| Less than 4 hours | 17 |
| 4 hours to less than 8 hours | 29 |
| 8 hours to less than 12 hours | 23 |
| 12 hours or more | 40 |
| All day | 32 |
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.
| participants | Fentanyl |
|---|---|
| Can sleep well | 28 |
| Can sleep moderately well | 67 |
| Cannot sleep much | 40 |
| Cannot sleep at all | 6 |
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.
| treatments per day | Fentanyl |
|---|---|
| Number of Rescue Treatments | 1.0 ± 1.13 |
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.
| units on a scale | Fentanyl |
|---|---|
| Physical health (summary score) | 23.0 ± 17.49 |
| Mental health (summary score) | 42.1 ± 9.82 |
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.
| participants | Fentanyl |
|---|---|
| Effective | 106 |
| Ineffective | 36 |
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.
| percentage of participants | Fentanyl |
|---|---|
| Satisfied | 31.2 (23.7 to 39.5) |
| Neither satisfied nor dissatisfied | 66.7 (58.2 to 74.4) |
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.
| units on a scale | Fentanyl |
|---|---|
| Brief Pain Inventory-Short Form (BPI-SF) Total Score | 5.1 ± 2.24 |
Collected over Baseline up to 7 days post last dose of study drug. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fentanyl | — | 38/142 (26.8%) | 140/142 (98.6%) |
| Event | Fentanyl |
|---|---|
| NauseaGastrointestinal disorders | 6/142 |
| PneumoniaInfections and infestations | 4/142 |
| Decreased appetiteMetabolism and nutrition disorders | 2/142 |
| SomnolenceNervous system disorders | 2/142 |
| VomitingGastrointestinal disorders | 2/142 |
| Spinal compression fractureInjury, poisoning and procedural complications | 2/142 |
| Acute tonsillitisInfections and infestations | 1/142 |
| Herpes zosterInfections and infestations | 1/142 |
| PharyngitisInfections and infestations | 1/142 |
| Pneumonia chlamydialInfections and infestations | 1/142 |
| Event | Fentanyl |
|---|---|
| SomnolenceNervous system disorders | 78/142 |
| ConstipationGastrointestinal disorders | 73/142 |
| NauseaGastrointestinal disorders | 71/142 |
| DizzinessNervous system disorders | 39/142 |
| NasopharyngitisInfections and infestations | 35/142 |
| VomitingGastrointestinal disorders | 19/142 |
| Decreased appetiteMetabolism and nutrition disorders | 18/142 |
| DiarrhoeaGastrointestinal disorders | 18/142 |
| PruritusSkin and subcutaneous tissue disorders | 18/142 |
| Application site pruritusGeneral disorders | 15/142 |
| Age Continuous(years) | Fentanyl |
|---|---|
| Mean | 61.4 ± 14.98 |
| Sex: Female, Male(Participants) | Fentanyl |
|---|---|
| Female | 64 |
| Male | 78 |
This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.
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Janssen Pharmaceutical K.K.