Cancer, Pain
Conditions
Keywords
Pain, Cancer, Fentanyl, JNS020QD
Brief summary
The purpose of this study is to evaluate the safety and efficacy of fentanyl one-day transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) in participants switched from morphine preparations, oral oxycodone preparations, fentanyl citrate injection or fentanyl patch for cancer pain.
Detailed description
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 3 periods: Pre-treatment observation period (4-7 days), Treatment period (10 days) and Follow-up period (2 days). Treatment will be initiated at 12.5 microgram per hour (mcg/hr) and the initial dose of fentanyl will be determined based on the daily dose of the opioid analgesic taken by the participant before entering the study and will be maintained for 2 days to ensure safety of participants. Dose escalation or reduction will be as per the Investigator's discretion from Day 3 to Day 7 and thereafter dose will be again maintained from Day 7 to Day 9, ranging from 12.5 mcg/hr-100 mcg/hr and the maximum application dose will be 300 mcg/hr. The patch will be applied on areas including the chest, abdomen, upper arm or thigh and will be replaced daily for 10 days (a total of 9 applications; including the day of final patch removal). Efficacy will primarily be evaluated by visual analog scale (VAS) score. Participants' safety will be monitored throughout the study.
Interventions
DRUGFentanyl
Fentanyl 1-day application transdermal patch releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction is as per Investigator's discretion (maximum applied dose is 300 mcg/hr) up to Day 7 and then dose is fixed for next 3 days that is Day 10 (end of treatment period).
Sponsors
Janssen Pharmaceutical K.K.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants receiving any of the following drugs at a stable dose for at least 3 days (or 9 days in case of fentanyl patch) before the start of application of the study drug: Morphine preparations at less than or equal to 314 milligram per day (mg/day) as an oral morphine equivalent dose of less than or equal to 157 mg/day for suppository or less than or equal to 104 mg/day for injection, oral oxycodone preparations at less than or equal to 209 mg/day, fentanyl citrate injection at less than or equal to 2.0 mg/day, fentanyl patch less than or equal to 7.5 mg * Participants assumed to use not more than 2 rescue doses (dose of a fast-acting opioid analgesic except fentanyl preparations used for lack of analgesic effect) daily for at least 3 days before the start of application of the study drug * Participants showing a pain intensity of less than or equal to 34 millimeter (mm) on a 100-mm visual analog scale (VAS) * Participants who have an established diagnosis of cancer and are notified of the disease * Participants who can be hospitalized during the course of application of the study drug
Exclusion criteria
* Participants with impaired respiratory function due to chronic lung disease or others * Participants with asthma (breathing disorder in which there is wheezing and difficulty in breathing or participants with bradyarrhythmia (slow, irregular heartbeats) * Participants with following measurements indicative of hepatic or renal impairment during the pre-treatment observation period: Aspartate transaminase (AST) greater than 5 times the upper limit of reference range, Alanine transaminase (ALT) greater than 5 times the upper limit of reference range, serum creatinine greater than 3 times the upper limit of reference range * Participants with any cerebral damage, such as brain tumor, accompanied by increased intracranial pressure, disturbance of consciousness, coma, or respiratory disturbance * Participants with a history of hypersensitivity to fentanyl or other opioid analgesics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Pain Control | Day 10 or early discontinuation (ED) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity Visual Analog Scale (VAS) Score | Day 1 (pre-application), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 or ED | Participants were asked to assess their resting pain intensity (severity of pain) on a 100-mm VAS with the left edge (0 mm) defined as no pain and the right edge (100 mm) defined as severest pain conceivable. |
| Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain | Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 or ED | Participants were asked to assess their resting pain intensity (severity of pain) on a 4-point categorical scale ranging from 0 to 3 where 0 = no pain, 1 = mild pain, 2 = moderate pain and 3 = severe pain. |
| Number of Participants With Response Based on Patient's Global Assessment Scale | Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 or ED | Participants were asked to assess their satisfaction with respect to the therapeutic efficacy (effectiveness) of the study drug on a 5-point scale ranging from 1 to 5, where 1 = extremely satisfied, 2 = satisfied, 3 = neither satisfied nor dissatisfied, 4 = dissatisfied and 5 = extremely dissatisfied. |
| Mean Number of Rescue Doses | Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 or ED | Rescue dose was defined as the dose of a fast-acting opioid analgesic (except fentanyl preparations) given in case of breakthrough pain or lack of analgesic effect. |
| Number of Participants With Response Based on Physician's Global Assessment Scale | Day 10 or ED | The treating physician assessed the therapeutic efficacy (effectiveness) of the study drug by 2-point scale of effective and ineffective. Number of participants with effective and ineffective therapeutic efficacy with respect to the study drug were reported. |
| Number of Participants With Total Duration of Pain Per Day | Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 or ED | The participants assessed total painful time in 1 day on a 5-point scale ranging from 0 to 4 where 0 = less than (\<) 4 hours, 1 = greater than or equal to (\>=) 4 hours to less than 8 hours, 2 = greater than or equal to 8 hours to less than 12 hours, 3 = greater than or equal to 12 hours and 4 = 24 hours (all day). |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fentanyl Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator's discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period). | 66 |
| Total | 66 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 1 |
| Overall Study | Worsening of underlying disease | 3 |
Baseline characteristics
| Characteristic | Fentanyl |
|---|---|
| Age Continuous | 63.80 Years STANDARD_DEVIATION 12.67 |
| Sex: Female, Male Female | 31 Participants |
| Sex: Female, Male Male | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 56 / 66 |
| serious Total, serious adverse events | 6 / 66 |
Outcome results
Primary
Percentage of Participants Achieving Pain Control
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.
Time frame: Day 10 or early discontinuation (ED)
Population: Full Analysis Set (FAS) population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fentanyl | Percentage of Participants Achieving Pain Control | 81.8 Percentage of Participants |
Secondary
Mean Number of Rescue Doses
Rescue dose was defined as the dose of a fast-acting opioid analgesic (except fentanyl preparations) given in case of breakthrough pain or lack of analgesic effect.
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 or ED
Population: The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug. 'n' signifies those participants who were evaluable for this measure at given time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fentanyl | Mean Number of Rescue Doses | Day 1; (n=66) | 0.2 Rescue Doses | Standard Deviation 0.47 |
| Fentanyl | Mean Number of Rescue Doses | Day 2; (n=65) | 0.8 Rescue Doses | Standard Deviation 1.06 |
| Fentanyl | Mean Number of Rescue Doses | Day 3; (n=65) | 0.7 Rescue Doses | Standard Deviation 1.14 |
| Fentanyl | Mean Number of Rescue Doses | Day 4; (n=64) | 0.7 Rescue Doses | Standard Deviation 1.04 |
| Fentanyl | Mean Number of Rescue Doses | Day 5; (n=63) | 0.7 Rescue Doses | Standard Deviation 1.05 |
| Fentanyl | Mean Number of Rescue Doses | Day 6; (n=63) | 0.7 Rescue Doses | Standard Deviation 1.1 |
| Fentanyl | Mean Number of Rescue Doses | Day 7; (n=63) | 0.8 Rescue Doses | Standard Deviation 1.42 |
| Fentanyl | Mean Number of Rescue Doses | Day 8; (n=62) | 0.7 Rescue Doses | Standard Deviation 1.14 |
| Fentanyl | Mean Number of Rescue Doses | Day 9; (n=62) | 0.8 Rescue Doses | Standard Deviation 1.33 |
| Fentanyl | Mean Number of Rescue Doses | Day 10 or ED; (n=66) | 0.5 Rescue Doses | Standard Deviation 0.83 |
Secondary
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain
Participants were asked to assess their resting pain intensity (severity of pain) on a 4-point categorical scale ranging from 0 to 3 where 0 = no pain, 1 = mild pain, 2 = moderate pain and 3 = severe pain.
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 or ED
Population: The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug. 'n' signifies those participants who were evaluable for this measure at given time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fentanyl | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain | Day 1; No pain (n=66) | 12 Participants |
| Fentanyl | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain | Day 1; Mild pain (n=66) | 37 Participants |
| Fentanyl | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain | Day 1; Moderate pain (n=66) | 17 Participants |
| Fentanyl | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain | Day 1; Severe pain (n=66) | 0 Participants |
| Fentanyl | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain | Day 2; No pain (n=65) | 10 Participants |
| Fentanyl | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain | Day 2; Mild pain (n=65) | 34 Participants |
| Fentanyl | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain | Day 2; Moderate pain (n=65) | 21 Participants |
| Fentanyl | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain | Day 2; Severe pain (n=65) | 0 Participants |
| Fentanyl | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain | Day 3; No pain (n=65) | 14 Participants |
| Fentanyl | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain | Day 3; Mild pain (n=65) | 33 Participants |
| Fentanyl | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain | Day 3; Moderate pain (n=65) | 15 Participants |
| Fentanyl | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain | Day 3; Severe pain (n=65) | 3 Participants |
| Fentanyl | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain | Day 4; No pain (n=64) | 16 Participants |
| Fentanyl | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain | Day 4; Mild pain (n=64) | 34 Participants |
| Fentanyl | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain | Day 4; Moderate pain (n=64) | 13 Participants |
| Fentanyl | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain | Day 4; Severe pain (n=64) | 1 Participants |
| Fentanyl | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain | Day 5; No pain (n=63) | 15 Participants |
| Fentanyl | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain | Day 5; Mild pain (n=63) | 36 Participants |
| Fentanyl | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain | Day 5; Moderate pain (n=63) | 12 Participants |
| Fentanyl | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain | Day 5; Severe pain (n=63) | 0 Participants |
| Fentanyl | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain | Day 6; No pain (n=63) | 16 Participants |
| Fentanyl | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain | Day 6; Mild pain (n=63) | 38 Participants |
| Fentanyl | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain | Day 6; Moderate pain (n=63) | 8 Participants |
| Fentanyl | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain | Day 6; Severe pain (n=63) | 1 Participants |
| Fentanyl | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain | Day 7; No pain (n=63) | 14 Participants |
| Fentanyl | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain | Day 7; Mild pain (n=63) | 38 Participants |
| Fentanyl | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain | Day 7; Moderate pain (n=63) | 11 Participants |
| Fentanyl | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain | Day 7; Severe pain (n=63) | 0 Participants |
| Fentanyl | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain | Day 8; No pain (n=62) | 13 Participants |
| Fentanyl | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain | Day 8; Mild pain (n=62) | 38 Participants |
| Fentanyl | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain | Day 8; Moderate pain (n=62) | 11 Participants |
| Fentanyl | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain | Day 8; Severe pain (n=62) | 0 Participants |
| Fentanyl | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain | Day 9; No pain (n=62) | 14 Participants |
| Fentanyl | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain | Day 9; Mild pain (n=62) | 40 Participants |
| Fentanyl | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain | Day 9; Moderate pain (n=62) | 7 Participants |
| Fentanyl | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain | Day 9; Severe pain (n=62) | 1 Participants |
| Fentanyl | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain | Day 10 or ED; No pain (n=66) | 15 Participants |
| Fentanyl | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain | Day 10 or ED; Mild pain (n=66) | 40 Participants |
| Fentanyl | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain | Day 10 or ED; Moderate pain(n=66) | 8 Participants |
| Fentanyl | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain | Day 10 or ED; Severe pain(n=66) | 3 Participants |
Secondary
Number of Participants With Response Based on Patient's Global Assessment Scale
Participants were asked to assess their satisfaction with respect to the therapeutic efficacy (effectiveness) of the study drug on a 5-point scale ranging from 1 to 5, where 1 = extremely satisfied, 2 = satisfied, 3 = neither satisfied nor dissatisfied, 4 = dissatisfied and 5 = extremely dissatisfied.
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 or ED
Population: The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug. 'n' signifies those participants who were evaluable for this measure at given time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fentanyl | Number of Participants With Response Based on Patient's Global Assessment Scale | Day 2; Satisfied (n=65) | 31 Participants |
| Fentanyl | Number of Participants With Response Based on Patient's Global Assessment Scale | Day 1; Extremely satisfied (n=66) | 8 Participants |
| Fentanyl | Number of Participants With Response Based on Patient's Global Assessment Scale | Day 1; Satisfied (n=66) | 35 Participants |
| Fentanyl | Number of Participants With Response Based on Patient's Global Assessment Scale | Day 1; Neither satisfied nor dissatisfied (n=66) | 19 Participants |
| Fentanyl | Number of Participants With Response Based on Patient's Global Assessment Scale | Day 1; Dissatisfied (n=66) | 4 Participants |
| Fentanyl | Number of Participants With Response Based on Patient's Global Assessment Scale | Day 1; Extremely dissatisfied (n=66) | 0 Participants |
| Fentanyl | Number of Participants With Response Based on Patient's Global Assessment Scale | Day 2; Extremely satisfied (n=65) | 8 Participants |
| Fentanyl | Number of Participants With Response Based on Patient's Global Assessment Scale | Day 2; Neither satisfied nor dissatisfied (n=65) | 24 Participants |
| Fentanyl | Number of Participants With Response Based on Patient's Global Assessment Scale | Day 2; Dissatisfied (n=65) | 2 Participants |
| Fentanyl | Number of Participants With Response Based on Patient's Global Assessment Scale | Day 2; Extremely dissatisfied (n=65) | 0 Participants |
| Fentanyl | Number of Participants With Response Based on Patient's Global Assessment Scale | Day 3; Extremely satisfied (n=65) | 8 Participants |
| Fentanyl | Number of Participants With Response Based on Patient's Global Assessment Scale | Day 3; Satisfied (n=65) | 25 Participants |
| Fentanyl | Number of Participants With Response Based on Patient's Global Assessment Scale | Day 3; Neither satisfied nor dissatisfied (n=65) | 25 Participants |
| Fentanyl | Number of Participants With Response Based on Patient's Global Assessment Scale | Day 3; Dissatisfied (n=65) | 7 Participants |
| Fentanyl | Number of Participants With Response Based on Patient's Global Assessment Scale | Day 3; Extremely dissatisfied (n=65) | 0 Participants |
| Fentanyl | Number of Participants With Response Based on Patient's Global Assessment Scale | Day 4; Extremely satisfied (n=64) | 9 Participants |
| Fentanyl | Number of Participants With Response Based on Patient's Global Assessment Scale | Day 4; Satisfied (n=64) | 28 Participants |
| Fentanyl | Number of Participants With Response Based on Patient's Global Assessment Scale | Day 4; Neither satisfied nor dissatisfied (n=64) | 24 Participants |
| Fentanyl | Number of Participants With Response Based on Patient's Global Assessment Scale | Day 4; Dissatisfied (n=64) | 3 Participants |
| Fentanyl | Number of Participants With Response Based on Patient's Global Assessment Scale | Day 4; Extremely dissatisfied (n=64) | 0 Participants |
| Fentanyl | Number of Participants With Response Based on Patient's Global Assessment Scale | Day 5; Extremely satisfied (n=63) | 10 Participants |
| Fentanyl | Number of Participants With Response Based on Patient's Global Assessment Scale | Day 5; Satisfied (n=63) | 30 Participants |
| Fentanyl | Number of Participants With Response Based on Patient's Global Assessment Scale | Day 5; Neither satisfied nor dissatisfied (n=63) | 19 Participants |
| Fentanyl | Number of Participants With Response Based on Patient's Global Assessment Scale | Day 5; Dissatisfied (n=63) | 3 Participants |
| Fentanyl | Number of Participants With Response Based on Patient's Global Assessment Scale | Day 5; Extremely dissatisfied (n=63) | 1 Participants |
| Fentanyl | Number of Participants With Response Based on Patient's Global Assessment Scale | Day 6; Extremely satisfied (n=63) | 9 Participants |
| Fentanyl | Number of Participants With Response Based on Patient's Global Assessment Scale | Day 6; Satisfied (n=63) | 31 Participants |
| Fentanyl | Number of Participants With Response Based on Patient's Global Assessment Scale | Day 6; Neither satisfied nor dissatisfied (n=63) | 20 Participants |
| Fentanyl | Number of Participants With Response Based on Patient's Global Assessment Scale | Day 6; Dissatisfied (n=63) | 3 Participants |
| Fentanyl | Number of Participants With Response Based on Patient's Global Assessment Scale | Day 6; Extremely dissatisfied (n=63) | 0 Participants |
| Fentanyl | Number of Participants With Response Based on Patient's Global Assessment Scale | Day 7; Extremely satisfied (n=63) | 10 Participants |
| Fentanyl | Number of Participants With Response Based on Patient's Global Assessment Scale | Day 7; Satisfied (n=63) | 31 Participants |
| Fentanyl | Number of Participants With Response Based on Patient's Global Assessment Scale | Day 7; Neither satisfied nor dissatisfied (n=63) | 18 Participants |
| Fentanyl | Number of Participants With Response Based on Patient's Global Assessment Scale | Day 7; Dissatisfied (n=63) | 4 Participants |
| Fentanyl | Number of Participants With Response Based on Patient's Global Assessment Scale | Day 7; Extremely dissatisfied (n=63) | 0 Participants |
| Fentanyl | Number of Participants With Response Based on Patient's Global Assessment Scale | Day 8; Extremely satisfied (n=62) | 10 Participants |
| Fentanyl | Number of Participants With Response Based on Patient's Global Assessment Scale | Day 8; Satisfied (n=62) | 30 Participants |
| Fentanyl | Number of Participants With Response Based on Patient's Global Assessment Scale | Day 8; Neither satisfied nor dissatisfied (n=62) | 19 Participants |
| Fentanyl | Number of Participants With Response Based on Patient's Global Assessment Scale | Day 8; Dissatisfied (n=62) | 3 Participants |
| Fentanyl | Number of Participants With Response Based on Patient's Global Assessment Scale | Day 8; Extremely dissatisfied (n=62) | 0 Participants |
| Fentanyl | Number of Participants With Response Based on Patient's Global Assessment Scale | Day 9; Extremely satisfied (n=62) | 11 Participants |
| Fentanyl | Number of Participants With Response Based on Patient's Global Assessment Scale | Day 9; Satisfied (n=62) | 32 Participants |
| Fentanyl | Number of Participants With Response Based on Patient's Global Assessment Scale | Day 9; Neither satisfied nor dissatisfied (n=62) | 17 Participants |
| Fentanyl | Number of Participants With Response Based on Patient's Global Assessment Scale | Day 9; Dissatisfied (n=62) | 2 Participants |
| Fentanyl | Number of Participants With Response Based on Patient's Global Assessment Scale | Day 9; Extremely dissatisfied (n=62) | 0 Participants |
| Fentanyl | Number of Participants With Response Based on Patient's Global Assessment Scale | Day 10/ED; Extremely satisfied (n=66) | 10 Participants |
| Fentanyl | Number of Participants With Response Based on Patient's Global Assessment Scale | Day 10/ED; Satisfied (n=66) | 30 Participants |
| Fentanyl | Number of Participants With Response Based on Patient's Global Assessment Scale | Day 10/ED;Neither satisfied nor dissatisfied(n=66) | 20 Participants |
| Fentanyl | Number of Participants With Response Based on Patient's Global Assessment Scale | Day 10/ED; Dissatisfied (n=66) | 6 Participants |
| Fentanyl | Number of Participants With Response Based on Patient's Global Assessment Scale | Day 10/ED; Extremely dissatisfied (n=66) | 0 Participants |
Secondary
Number of Participants With Response Based on Physician's Global Assessment Scale
The treating physician assessed the therapeutic efficacy (effectiveness) of the study drug by 2-point scale of effective and ineffective. Number of participants with effective and ineffective therapeutic efficacy with respect to the study drug were reported.
Time frame: Day 10 or ED
Population: The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fentanyl | Number of Participants With Response Based on Physician's Global Assessment Scale | Effective | 63 Participants |
| Fentanyl | Number of Participants With Response Based on Physician's Global Assessment Scale | Ineffective | 3 Participants |
Secondary
Number of Participants With Total Duration of Pain Per Day
The participants assessed total painful time in 1 day on a 5-point scale ranging from 0 to 4 where 0 = less than (\<) 4 hours, 1 = greater than or equal to (\>=) 4 hours to less than 8 hours, 2 = greater than or equal to 8 hours to less than 12 hours, 3 = greater than or equal to 12 hours and 4 = 24 hours (all day).
Time frame: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 or ED
Population: The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug. 'n' signifies those participants who were evaluable for this measure at given time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fentanyl | Number of Participants With Total Duration of Pain Per Day | Day 2; >= 4 to < 8 hours (n=65) | 9 Participants |
| Fentanyl | Number of Participants With Total Duration of Pain Per Day | Day 1; < 4 hours (n=66) | 44 Participants |
| Fentanyl | Number of Participants With Total Duration of Pain Per Day | Day 1; >= 4 to < 8 hours (n=66) | 9 Participants |
| Fentanyl | Number of Participants With Total Duration of Pain Per Day | Day 1; >= 8 to < 12 hours (n=66) | 6 Participants |
| Fentanyl | Number of Participants With Total Duration of Pain Per Day | Day 1; >= 12 hours (n=66) | 0 Participants |
| Fentanyl | Number of Participants With Total Duration of Pain Per Day | Day 1; 24 hours (n=66) | 7 Participants |
| Fentanyl | Number of Participants With Total Duration of Pain Per Day | Day 2; < 4 hours (n=65) | 44 Participants |
| Fentanyl | Number of Participants With Total Duration of Pain Per Day | Day 2; >= 8 to < 12 hours (n=65) | 6 Participants |
| Fentanyl | Number of Participants With Total Duration of Pain Per Day | Day 2; >= 12 hours (n=65) | 1 Participants |
| Fentanyl | Number of Participants With Total Duration of Pain Per Day | Day 2; 24 hours (n=65) | 5 Participants |
| Fentanyl | Number of Participants With Total Duration of Pain Per Day | Day 3; < 4 hours (n=65) | 41 Participants |
| Fentanyl | Number of Participants With Total Duration of Pain Per Day | Day 3; >= 4 to < 8 hours (n=65) | 6 Participants |
| Fentanyl | Number of Participants With Total Duration of Pain Per Day | Day 3; >= 8 to < 12 hours (n=65) | 9 Participants |
| Fentanyl | Number of Participants With Total Duration of Pain Per Day | Day 3; >= 12 hours (n=65) | 3 Participants |
| Fentanyl | Number of Participants With Total Duration of Pain Per Day | Day 3; 24 hours (n=65) | 6 Participants |
| Fentanyl | Number of Participants With Total Duration of Pain Per Day | Day 4; < 4 hours (n=64) | 47 Participants |
| Fentanyl | Number of Participants With Total Duration of Pain Per Day | Day 4; >= 4 to < 8 hours (n=64) | 8 Participants |
| Fentanyl | Number of Participants With Total Duration of Pain Per Day | Day 4; >= 8 to < 12 hours (n=64) | 2 Participants |
| Fentanyl | Number of Participants With Total Duration of Pain Per Day | Day 4; >= 12 hours (n=64) | 2 Participants |
| Fentanyl | Number of Participants With Total Duration of Pain Per Day | Day 4; 24 hours (n=64) | 5 Participants |
| Fentanyl | Number of Participants With Total Duration of Pain Per Day | Day 5; < 4 hours (n=63) | 45 Participants |
| Fentanyl | Number of Participants With Total Duration of Pain Per Day | Day 5; >= 4 to < 8 hours (n=63) | 10 Participants |
| Fentanyl | Number of Participants With Total Duration of Pain Per Day | Day 5; >= 8 to < 12 hours (n=63) | 2 Participants |
| Fentanyl | Number of Participants With Total Duration of Pain Per Day | Day 5; >= 12 hours (n=63) | 1 Participants |
| Fentanyl | Number of Participants With Total Duration of Pain Per Day | Day 5; 24 hours (n=63) | 5 Participants |
| Fentanyl | Number of Participants With Total Duration of Pain Per Day | Day 6; < 4 hours (n=63) | 46 Participants |
| Fentanyl | Number of Participants With Total Duration of Pain Per Day | Day 6; >= 4 to < 8 hours (n=63) | 6 Participants |
| Fentanyl | Number of Participants With Total Duration of Pain Per Day | Day 6; >= 8 to < 12 hours (n=63) | 3 Participants |
| Fentanyl | Number of Participants With Total Duration of Pain Per Day | Day 6; >= 12 hours (n=63) | 1 Participants |
| Fentanyl | Number of Participants With Total Duration of Pain Per Day | Day 6; 24 hours (n=63) | 7 Participants |
| Fentanyl | Number of Participants With Total Duration of Pain Per Day | Day 7; < 4 hours (n=63) | 44 Participants |
| Fentanyl | Number of Participants With Total Duration of Pain Per Day | Day 7; >= 4 to < 8 hours (n=63) | 7 Participants |
| Fentanyl | Number of Participants With Total Duration of Pain Per Day | Day 7; >= 8 to < 12 hours (n=63) | 4 Participants |
| Fentanyl | Number of Participants With Total Duration of Pain Per Day | Day 7; >= 12 hours (n=63) | 1 Participants |
| Fentanyl | Number of Participants With Total Duration of Pain Per Day | Day 7; 24 hours (n=63) | 7 Participants |
| Fentanyl | Number of Participants With Total Duration of Pain Per Day | Day 8; < 4 hours (n=62) | 44 Participants |
| Fentanyl | Number of Participants With Total Duration of Pain Per Day | Day 8; >= 4 to < 8 hours (n=62) | 6 Participants |
| Fentanyl | Number of Participants With Total Duration of Pain Per Day | Day 8; >= 8 to < 12 hours (n=62) | 4 Participants |
| Fentanyl | Number of Participants With Total Duration of Pain Per Day | Day 8; >= 12 hours (n=62) | 1 Participants |
| Fentanyl | Number of Participants With Total Duration of Pain Per Day | Day 8; 24 hours (n=62) | 7 Participants |
| Fentanyl | Number of Participants With Total Duration of Pain Per Day | Day 9; < 4 hours (n=62) | 47 Participants |
| Fentanyl | Number of Participants With Total Duration of Pain Per Day | Day 9; >= 4 to < 8 hours (n=62) | 6 Participants |
| Fentanyl | Number of Participants With Total Duration of Pain Per Day | Day 9; >= 8 to < 12 hours (n=62) | 3 Participants |
| Fentanyl | Number of Participants With Total Duration of Pain Per Day | Day 9; >= 12 hours (n=62) | 1 Participants |
| Fentanyl | Number of Participants With Total Duration of Pain Per Day | Day 9; 24 hours (n=62) | 5 Participants |
| Fentanyl | Number of Participants With Total Duration of Pain Per Day | Day 10 or ED; < 4 hours (n=66) | 50 Participants |
| Fentanyl | Number of Participants With Total Duration of Pain Per Day | Day 10 or ED; >=4 to < 8 hours (n=66) | 6 Participants |
| Fentanyl | Number of Participants With Total Duration of Pain Per Day | Day 10 or ED; >=8 to <12 hours (n=66) | 3 Participants |
| Fentanyl | Number of Participants With Total Duration of Pain Per Day | Day 10 or ED; >= 12 hours (n=66) | 2 Participants |
| Fentanyl | Number of Participants With Total Duration of Pain Per Day | Day 10 or ED; 24 hours (n=66) | 5 Participants |
Secondary
Pain Intensity Visual Analog Scale (VAS) Score
Participants were asked to assess their resting pain intensity (severity of pain) on a 100-mm VAS with the left edge (0 mm) defined as no pain and the right edge (100 mm) defined as severest pain conceivable.
Time frame: Day 1 (pre-application), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 or ED
Population: The FAS population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug. 'n' signifies those participants who were evaluable for this measure at given time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fentanyl | Pain Intensity Visual Analog Scale (VAS) Score | Day 1 pre-application; (n=66) | 15.6 mm | Standard Deviation 11.77 |
| Fentanyl | Pain Intensity Visual Analog Scale (VAS) Score | Day 2; (n=65) | 16.1 mm | Standard Deviation 11.95 |
| Fentanyl | Pain Intensity Visual Analog Scale (VAS) Score | Day 3; (n=65) | 18.6 mm | Standard Deviation 15.84 |
| Fentanyl | Pain Intensity Visual Analog Scale (VAS) Score | Day 4; (n=64) | 15.1 mm | Standard Deviation 13.09 |
| Fentanyl | Pain Intensity Visual Analog Scale (VAS) Score | Day 5; (n=63) | 15.2 mm | Standard Deviation 14.31 |
| Fentanyl | Pain Intensity Visual Analog Scale (VAS) Score | Day 6; (n=63) | 15.3 mm | Standard Deviation 12.68 |
| Fentanyl | Pain Intensity Visual Analog Scale (VAS) Score | Day 7; (n=63) | 14.7 mm | Standard Deviation 13.47 |
| Fentanyl | Pain Intensity Visual Analog Scale (VAS) Score | Day 8; (n=62) | 14.9 mm | Standard Deviation 14.34 |
| Fentanyl | Pain Intensity Visual Analog Scale (VAS) Score | Day 9; (n=62) | 15.1 mm | Standard Deviation 13.38 |
| Fentanyl | Pain Intensity Visual Analog Scale (VAS) Score | Day 10 or ED; (n=66) | 15.5 mm | Standard Deviation 13.34 |