Cancer, Pain
Conditions
Keywords
Pain, Cancer, Fentanyl, JNS020QD, JNS005
Brief summary
The purpose of this study is to evaluate the efficacy and safety of fentanyl 1-day application (JNS020QD) transdermal patch (patch containing a drug that is put on the skin so the drug can enter the body through the skin) and to assess the non-inferiority of fentanyl 1-day application transdermal patch to fentanyl 3-day application (JNS005) transdermal patch in participants with cancer pain.
Detailed description
This is a multi-center (conducted in more than one center) study, consisting of two periods: Period 1 is open-label (all people know the identity of the intervention), non-comparative dose titration phase and Period 2 is double blind (neither physician nor participant knows the treatment that the participant receives), positive control (fentanyl 3-day application transdermal patch is used as control drug) phase. In Period 1, fentanyl 1-day application transdermal patch 12.5 microgram per hour (mcg/hr) will be applied to chest, abdomen, upper arm or thigh and will be maintained for 2 days to ensure the safety of participants. Dose escalation or reduction will be allowed based on participant's condition from Day 3 to Day 11 and thereafter dose will be maintained from Day 11 to Day 13 with a maximum application dose of 100 mcg/hr. The total duration of Period 1 is 14 days (a total of 13 applications; including the day of final patch removal). Participants who met the predefined criteria at the end of dose titration phase will enter the double blind phase. In double blind phase, participants will receive either fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application transdermal patch or fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch at the same dose as used at the completion of Period 1. The duration of Period 2 is 10 days. Efficacy will primarily be evaluated by percentage of participants achieving dose titration success and change in mean visual analog scale (VAS) score. Participants' safety will be monitored throughout the study.
Interventions
DRUGFentanyl 1-day transdermal patch (Titration Phase)
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.
DRUGFentanyl 1-day transdermal patch (Double Blind Phase)
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.
DRUGFentanyl 3-day transdermal patch (Double Blind Phase)
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.
DRUGPlacebo
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.
Sponsors
Janssen Pharmaceutical K.K.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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 insufficient response to non-opioid analgesics and require treatment with opioid analgesics by the physician * Participants who have an established diagnosis of cancer and are notified of the disease * Participants who can be hospitalized during Period 1 (dose-titration period)
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) * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Dose Titration Success | Day 14 or early discontinuation (ED) | 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. |
| Change From Dose Titration Phase in the Mean Visual Analog Scale (VAS) Score at Double Blind Phase | Dose Titration Phase (Day 12 to Day 14) and Double Blind Phase (Day 8 to Day 10) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 1 pre-application (PA), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12, Day 13 and Day 14 or ED | Participants were asked to assess their satisfaction with respect to the therapeutic efficacy (effectiveness) of the study drug to control pain 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. |
| Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 14-End of Titration Phase (ETP), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9 and Day 10 or ED | Participants were asked to assess their satisfaction with respect to the therapeutic efficacy of the study drug to control pain 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. |
| Pain Intensity Visual Analog Scale (VAS) Score in Titration Phase | Day 1 PA, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12, Day 13 and Day 14 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. |
| Pain Intensity Visual Analog Scale (VAS) Score in Double Blind Phase | Day 14-End of Titration Phase (ETP), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9 and 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. |
| Percentage of Participants Achieving Pain Control in Double Blind Phase | Day 10 or ED | Pain control was assessed based on change in VAS and number of daily rescue doses during 3 days before completion of Double Blind Phase from 3 days before start of Double Blind Phase. For VAS score, difference of less than or equal to +15 mm and for rescue doses, difference of less than or equal to 1 was considered significant to achieve pain control. Pain Intensity VAS measured pain severity on a scale ranging from 0 mm (no pain) to 100 mm (severest pain conceivable) and rescue dose was defined as dose of fast-acting oral morphine formulation used in case of breakthrough pain. |
| Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase | Day 1 PA, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12, Day 13 and Day 14 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 Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 14-End of Titration Phase (ETP), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9 and 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 Total Duration of Pain Per Day in Titration Phase | Day 1 PA, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12, Day 13 and Day 14 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). |
| Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 14-End of Titration Phase (ETP), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9 and 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). |
| Mean Number of Rescue Doses in Titration Phase | Day 1 PA, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12, Day 13 and Day 14 or ED | 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 or lack of analgesic effect. |
| Mean Number of Rescue Doses in Double Blind Phase | Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9 and Day 10 or ED | 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 or lack of analgesic effect. |
| Number of Participants With Response Based on Physician's Global Assessment Scale in Titration Phase | Day 14 | The treating physician assessed the therapeutic efficacy of the study drug to control pain on a 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 Response Based on Physician's Global Assessment Scale in Double Blind Phase | Day 10 | The treating physician assessed the therapeutic efficacy of the study drug to control pain on a 2-point scale of effective and ineffective. Number of participants with effective and ineffective therapeutic efficacy with respect to the study drug were reported. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fentanyl 1-day Transdermal Patch (Titration Phase) Fentanyl 1-day application (JNS020QD) transdermal patch (patch containing a drug that was put on skin so the drug entered the body through the skin) 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 was done as per Investigator's discretion (maximum applied dose was 100 mcg/hr) up to Day 11 and then dose was fixed up to end of treatment period, that is Day 14. Participants who met the predefined criteria at the end of Titration Phase entered the Double Blind Phase. | 155 |
| Total | 155 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Period 1: Titration Phase | Adverse Event | 11 | 0 | 0 |
| Period 1: Titration Phase | Dose adjustment required on Day 12 or 13 | 3 | 0 | 0 |
| Period 1: Titration Phase | Participant was judged as ineligible | 3 | 0 | 0 |
| Period 1: Titration Phase | Physician Decision | 1 | 0 | 0 |
| Period 1: Titration Phase | Withdrawal by Subject | 2 | 0 | 0 |
| Period 1: Titration Phase | Worsening of complications | 1 | 0 | 0 |
| Period 1: Titration Phase | Worsening of symptoms | 1 | 0 | 0 |
| Period 1: Titration Phase | Worsening of underlying disease | 5 | 0 | 0 |
| Period 2: Double Blind Phase | Adverse Event | 0 | 2 | 4 |
| Period 2: Double Blind Phase | Withdrawal by Subject | 0 | 1 | 0 |
| Period 2: Double Blind Phase | Worsening of symptoms | 0 | 0 | 1 |
| Period 2: Double Blind Phase | Worsening of underlying disease | 0 | 6 | 2 |
Baseline characteristics
| Characteristic | Fentanyl 1-day Transdermal Patch (Titration Phase) |
|---|---|
| Age Continuous | 68.7 Years STANDARD_DEVIATION 9.52 |
| Sex: Female, Male Female | 61 Participants |
| Sex: Female, Male Male | 94 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 128 / 155 | 47 / 57 | 48 / 62 |
| serious Total, serious adverse events | 14 / 155 | 9 / 57 | 11 / 62 |
Outcome results
Primary
Change From Dose Titration Phase in the Mean Visual Analog Scale (VAS) Score at Double Blind Phase
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).
Time frame: Dose Titration Phase (Day 12 to Day 14) and Double Blind Phase (Day 8 to Day 10)
Population: Per Protocol Set (PPS) population included all the participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug excluding those with any major protocol deviation or other violations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Change From Dose Titration Phase in the Mean Visual Analog Scale (VAS) Score at Double Blind Phase | Dose Titration Phase (Day 12 to Day 14) | 18.4 mm | Standard Deviation 9.05 |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Change From Dose Titration Phase in the Mean Visual Analog Scale (VAS) Score at Double Blind Phase | Change at Double Blind Phase (Day 8 to Day 10) | -1.1 mm | Standard Deviation 14.82 |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Change From Dose Titration Phase in the Mean Visual Analog Scale (VAS) Score at Double Blind Phase | Dose Titration Phase (Day 12 to Day 14) | 20.6 mm | Standard Deviation 8.58 |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Change From Dose Titration Phase in the Mean Visual Analog Scale (VAS) Score at Double Blind Phase | Change at Double Blind Phase (Day 8 to Day 10) | -2.5 mm | Standard Deviation 11.32 |
95% CI: [-3.5, 6.23]
Primary
Percentage of Participants Achieving Dose Titration Success
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.
Time frame: Day 14 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 1-day Transdermal Patch (Titration Phase) | Percentage of Participants Achieving Dose Titration Success | 80.60 Percentage of participants |
Secondary
Mean Number of Rescue Doses in Double Blind Phase
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 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 and Day 10 or ED
Population: The PPS population included all the participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug excluding those with any major protocol deviation or other violations. 'n' signifies those participants who were evaluable for this measure at given time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Mean Number of Rescue Doses in Double Blind Phase | Day 3; (54,60) | 0.3 Rescue doses | Standard Deviation 0.7 |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Mean Number of Rescue Doses in Double Blind Phase | Day 6; (50,60) | 0.3 Rescue doses | Standard Deviation 0.71 |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Mean Number of Rescue Doses in Double Blind Phase | Day 7; (50,59) | 0.3 Rescue doses | Standard Deviation 0.65 |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Mean Number of Rescue Doses in Double Blind Phase | Day 2; (54,60) | 0.3 Rescue doses | Standard Deviation 0.63 |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Mean Number of Rescue Doses in Double Blind Phase | Day 8; (50,59) | 0.5 Rescue doses | Standard Deviation 0.93 |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Mean Number of Rescue Doses in Double Blind Phase | Day 4; (54,60) | 0.4 Rescue doses | Standard Deviation 0.7 |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Mean Number of Rescue Doses in Double Blind Phase | Day 9; (49,56) | 0.5 Rescue doses | Standard Deviation 1.1 |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Mean Number of Rescue Doses in Double Blind Phase | Day 1; (n=54,60) | 0.1 Rescue doses | Standard Deviation 0.41 |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Mean Number of Rescue Doses in Double Blind Phase | Day 5; (52,60) | 0.3 Rescue doses | Standard Deviation 0.7 |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Mean Number of Rescue Doses in Double Blind Phase | Day 10 or ED; (54,60) | 0.2 Rescue doses | Standard Deviation 0.49 |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Mean Number of Rescue Doses in Double Blind Phase | Day 5; (52,60) | 0.5 Rescue doses | Standard Deviation 0.75 |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Mean Number of Rescue Doses in Double Blind Phase | Day 1; (n=54,60) | 0.2 Rescue doses | Standard Deviation 0.44 |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Mean Number of Rescue Doses in Double Blind Phase | Day 2; (54,60) | 0.4 Rescue doses | Standard Deviation 0.74 |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Mean Number of Rescue Doses in Double Blind Phase | Day 3; (54,60) | 0.4 Rescue doses | Standard Deviation 0.79 |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Mean Number of Rescue Doses in Double Blind Phase | Day 4; (54,60) | 0.4 Rescue doses | Standard Deviation 0.79 |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Mean Number of Rescue Doses in Double Blind Phase | Day 6; (50,60) | 0.6 Rescue doses | Standard Deviation 0.87 |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Mean Number of Rescue Doses in Double Blind Phase | Day 7; (50,59) | 0.5 Rescue doses | Standard Deviation 1.04 |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Mean Number of Rescue Doses in Double Blind Phase | Day 8; (50,59) | 0.5 Rescue doses | Standard Deviation 0.9 |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Mean Number of Rescue Doses in Double Blind Phase | Day 9; (49,56) | 0.5 Rescue doses | Standard Deviation 0.79 |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Mean Number of Rescue Doses in Double Blind Phase | Day 10 or ED; (54,60) | 0.4 Rescue doses | Standard Deviation 0.82 |
Secondary
Mean Number of Rescue Doses in Titration Phase
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 or lack of analgesic effect.
Time frame: Day 1 PA, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12, Day 13 and Day 14 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 1-day Transdermal Patch (Titration Phase) | Mean Number of Rescue Doses in Titration Phase | Day 1 PA; (n=155) | 0.3 Rescue doses | Standard Deviation 0.64 |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Mean Number of Rescue Doses in Titration Phase | Day 2; (n=155) | 0.8 Rescue doses | Standard Deviation 1.17 |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Mean Number of Rescue Doses in Titration Phase | Day 3; (n=153) | 0.7 Rescue doses | Standard Deviation 1.03 |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Mean Number of Rescue Doses in Titration Phase | Day 4; (n=152) | 0.6 Rescue doses | Standard Deviation 1.04 |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Mean Number of Rescue Doses in Titration Phase | Day 5; (n=151) | 0.5 Rescue doses | Standard Deviation 0.7 |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Mean Number of Rescue Doses in Titration Phase | Day 6; (n=129) | 0.7 Rescue doses | Standard Deviation 0.93 |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Mean Number of Rescue Doses in Titration Phase | Day 7; (n=112) | 0.5 Rescue doses | Standard Deviation 0.82 |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Mean Number of Rescue Doses in Titration Phase | Day 8; (n=99) | 0.5 Rescue doses | Standard Deviation 0.86 |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Mean Number of Rescue Doses in Titration Phase | Day 9; (n=74) | 0.4 Rescue doses | Standard Deviation 0.66 |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Mean Number of Rescue Doses in Titration Phase | Day 10; (n=57) | 0.4 Rescue doses | Standard Deviation 0.75 |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Mean Number of Rescue Doses in Titration Phase | Day 11; (n=51) | 0.4 Rescue doses | Standard Deviation 0.85 |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Mean Number of Rescue Doses in Titration Phase | Day 12; (n=38) | 0.5 Rescue doses | Standard Deviation 0.83 |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Mean Number of Rescue Doses in Titration Phase | Day 13; (n=29) | 0.3 Rescue doses | Standard Deviation 0.6 |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Mean Number of Rescue Doses in Titration Phase | Day 14 or ED; (n=155) | 0.2 Rescue doses | Standard Deviation 0.52 |
Secondary
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase
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 14-End of Titration Phase (ETP), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9 and Day 10 or ED
Population: The PPS population included all the participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug excluding those with any major protocol deviation or other violations. 'n' signifies those participants who were evaluable for this measure at given time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 3; Moderate pain (n=54,60) | 9 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | ETP; MIld pain (n=54,60) | 39 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | ETP; Moderate pain (n=54,60) | 9 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | ETP; Severe pain (n=54,60) | 0 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 2; No pain (n=54,60) | 10 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 2; Mild pain (n=54,60) | 30 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 2; Moderate pain (n=54,60) | 14 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 2; Severe pain (n=54,60) | 0 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 3; No pain (n=54,60) | 9 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 3; Mild pain (n=54,60) | 34 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | ETP; No pain (n=54,60) | 6 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 3; Severe pain (n=54,60) | 2 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 4; No pain (n=54,60) | 8 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 4; Mild pain (n=54,60) | 36 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 4; Moderate pain (n=54,60) | 10 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 4; Severe pain (n=54,60) | 0 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 5; No pain (n=51,60) | 8 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 5; Mild pain (n=51,60) | 31 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 5; Moderate pain (n=51,60) | 11 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 5; Severe pain (n=51,60) | 1 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 6; No pain (n=50,60) | 10 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 6; Mild pain (n=50,60) | 30 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 6; Moderate pain (n=50,60) | 8 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 6; Severe pain (n=50,60) | 2 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 7; No pain (n=50,59) | 8 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 7; Mild pain (n=50,59) | 33 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 7; Moderate pain (n=50,59) | 8 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 7; Severe pain (n=50,59) | 1 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 8; No pain (n=50,59) | 10 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 8; Mild pain (n=50,59) | 29 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 8; Moderate pain (n=50,59) | 11 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 8; Severe pain (n=50,59) | 0 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 9; No pain (n=49,56) | 13 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 9; Mild pain (n=49,56) | 23 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 9; Moderate pain (n=49,56) | 12 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 9; Severe pain (n=49,56) | 1 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 10 or ED; No pain (n=54,60) | 12 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 10 or ED; Mild pain (n=54,60) | 29 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 10 or ED; Moderate pain (n=54,60) | 12 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 10 or ED; Severe pain (n=54,60) | 1 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 9; Severe pain (n=49,56) | 0 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | ETP; No pain (n=54,60) | 10 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 6; No pain (n=50,60) | 11 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | ETP; MIld pain (n=54,60) | 37 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 8; Moderate pain (n=50,59) | 13 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | ETP; Moderate pain (n=54,60) | 12 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 6; Mild pain (n=50,60) | 34 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | ETP; Severe pain (n=54,60) | 1 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 10 or ED; Moderate pain (n=54,60) | 18 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 2; No pain (n=54,60) | 9 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 6; Moderate pain (n=50,60) | 14 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 2; Mild pain (n=54,60) | 40 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 8; Severe pain (n=50,59) | 0 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 2; Moderate pain (n=54,60) | 11 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 6; Severe pain (n=50,60) | 1 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 2; Severe pain (n=54,60) | 0 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 10 or ED; No pain (n=54,60) | 11 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 3; No pain (n=54,60) | 12 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 7; No pain (n=50,59) | 11 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 3; Mild pain (n=54,60) | 39 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 9; No pain (n=49,56) | 10 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 3; Moderate pain (n=54,60) | 8 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 7; Mild pain (n=50,59) | 34 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 3; Severe pain (n=54,60) | 1 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 9; Mild pain (n=49,56) | 33 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 4; No pain (n=54,60) | 12 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 7; Moderate pain (n=50,59) | 12 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 4; Mild pain (n=54,60) | 41 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 10 or ED; Mild pain (n=54,60) | 30 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 4; Moderate pain (n=54,60) | 7 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 7; Severe pain (n=50,59) | 2 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 4; Severe pain (n=54,60) | 0 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 9; Moderate pain (n=49,56) | 13 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 5; No pain (n=51,60) | 11 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 8; No pain (n=50,59) | 10 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 5; Mild pain (n=51,60) | 42 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 10 or ED; Severe pain (n=54,60) | 1 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 5; Moderate pain (n=51,60) | 7 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 8; Mild pain (n=50,59) | 36 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase | Day 5; Severe pain (n=51,60) | 0 Participants |
Secondary
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase
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 PA, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12, Day 13 and Day 14 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 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase | Day 1 PA; No pain (n=155) | 0 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase | Day 1 PA; Mild pain (n=155) | 23 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase | Day 1 PA; moderate Pain (n=155) | 115 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase | Day 1 PA; severe Pain (n=155) | 17 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase | Day 2; No pain (n=155) | 4 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase | Day 2; Mild pain (n=155) | 54 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase | Day 2; Moderate pain (n=155) | 93 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase | Day 2; Severe pain (n=155) | 4 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase | Day 3; No pain (n=153) | 13 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase | Day 3; Mild pain (n=153) | 64 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase | Day 3; Moderate pain (n=153) | 69 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase | Day 3; Severe pain (n=153) | 7 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase | Day 4; No pain (n=152) | 12 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase | Day 4; Mild pain (n=152) | 68 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase | Day 4; Moderate pain (n=152) | 70 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase | Day 4; Severe pain (n=152) | 2 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase | Day 5; No pain (n=151) | 15 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase | Day 5; Mild pain (n=151) | 80 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase | Day 5; Moderate pain (n=151) | 50 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase | Day 5; Severe pain (n=151) | 6 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase | Day 6; No pain (n=129) | 13 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase | Day 6; Mild pain (n=129) | 69 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase | Day 6; Moderate pain (n=129) | 44 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase | Day 6; Severe pain (n=129) | 3 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase | Day 7; No pain (n=112) | 11 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase | Day 7; Mild pain (n=112) | 62 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase | Day 7; Moderate pain (n=112) | 36 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase | Day 7; Severe pain (n=112) | 3 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase | Day 8; No pain (n=98) | 9 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase | Day 8; Mild pain (n=98) | 56 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase | Day 8; Moderate pain (n=98) | 28 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase | Day 8; Severe pain (n=98) | 5 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase | Day 9; No pain (n=74) | 7 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase | Day 9; Mild pain (n=74) | 45 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase | Day 9; Moderate pain (n=74) | 22 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase | Day 9; Severe pain (n=74) | 0 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase | Day 10; No pain (n=57) | 3 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase | Day 10; Mild pain (n=57) | 31 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase | Day 10; Moderate pain (n=57) | 23 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase | Day 10; Severe pain (n=57) | 0 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase | Day 11; No pain (n=51) | 5 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase | Day 11; Mild pain (n=51) | 27 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase | Day 11; Moderate pain (n=51) | 18 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase | Day 11; Severe pain (n=51) | 1 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase | Day 12; No pain (n=38) | 5 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase | Day 12; Mild pain (n=38) | 21 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase | Day 12; Moderate pain (n=38) | 11 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase | Day 12; Severe pain (n=38) | 1 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase | Day 13; No pain (n=29) | 2 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase | Day 13; Mild pain (n=29) | 15 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase | Day 13; Moderate pain (n=29) | 12 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase | Day 13; Severe pain (n=29) | 0 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase | Day 14 or ED; No pain (n=155) | 20 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase | Day 14 or ED; Mild pain (n=155) | 92 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase | Day 14 or ED; Moderate pain(n=155) | 38 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase | Day 14 or ED; Severe pain(n=155) | 5 Participants |
Secondary
Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase
Participants were asked to assess their satisfaction with respect to the therapeutic efficacy of the study drug to control pain 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 14-End of Titration Phase (ETP), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9 and Day 10 or ED
Population: The PPS population included all the participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug excluding those with any major protocol deviation or other violations. 'n' signifies those participants who were evaluable for this measure at given time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | ETP; Extremely satisfied (n=54,60) | 3 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | ETP; Satisfied (n=54,60) | 31 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | ETP;Neither satisfied nor dissatisfied(n=54,60) | 19 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | ETP; Dissatisfied (n=54,60) | 1 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 2; Extremely satisfied (n=54,60) | 3 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 2; Satisfied (n=54,60) | 33 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 2;Neither satisfied nor dissatisfied(n=54,60) | 16 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 2; Dissatisfied (n=54,60) | 2 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 3; Extremely satisfied (n=54,60) | 3 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 3; Satisfied (n=54,60) | 32 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 3;Neither satisfied nor dissatisfied(n=54,60) | 16 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 3; Dissatisfied (n=54,60) | 3 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 4; Extremely satisfied (n=54,60) | 3 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 4; Satisfied (n=54,60) | 31 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 4;Neither satisfied nor dissatisfied(n=54,60) | 17 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 4; Dissatisfied (n=54,60) | 3 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 5; Extremely satisfied (n=51,60) | 5 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 5; Satisfied (n=51,60) | 28 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 5;Neither satisfied nor dissatisfied(n=51,60) | 17 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 5; Dissatisfied (n=51,60) | 1 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 6; Extremely satisfied (n=50,60) | 6 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 6; Satisfied (n=50,60) | 25 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 6;Neither satisfied nor dissatisfied(n=50,60) | 17 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 6; Dissatisfied (n=50,60) | 2 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 7; Extremely satisfied (n=50,59) | 5 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 7; Satisfied (n=50,59) | 27 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 7;Neither satisfied nor dissatisfied(n=50,59) | 18 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 7; Dissatisfied (n=50,59) | 0 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 8; Extremely satisfied (n=50,59) | 5 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 8; Satisfied (n=50,59) | 25 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 8;Neither satisfied nor dissatisfied(n=50,59) | 19 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 8; Dissatisfied (n=50,59) | 1 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 9; Extremely satisfied (n=49,56) | 6 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 9; Satisfied (n=49,56) | 22 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 9;Neither satisfied nor dissatisfied(n=49,56) | 21 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 9; Dissatisfied (n=49,56) | 0 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 10/ED; Extremely satisfied (n=54,60) | 6 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 10/ED; Satisfied (n=54,60) | 29 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day10/EDNeither satisfied nor dissatisfied;n=54,60 | 18 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 10/ED; Dissatisfied (n=54,60) | 1 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 6; Extremely satisfied (n=50,60) | 6 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | ETP; Extremely satisfied (n=54,60) | 4 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day10/EDNeither satisfied nor dissatisfied;n=54,60 | 17 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | ETP; Satisfied (n=54,60) | 37 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 6; Satisfied (n=50,60) | 34 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | ETP;Neither satisfied nor dissatisfied(n=54,60) | 16 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 8; Dissatisfied (n=50,59) | 7 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | ETP; Dissatisfied (n=54,60) | 3 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 6;Neither satisfied nor dissatisfied(n=50,60) | 15 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 2; Extremely satisfied (n=54,60) | 4 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 10/ED; Extremely satisfied (n=54,60) | 3 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 2; Satisfied (n=54,60) | 38 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 6; Dissatisfied (n=50,60) | 5 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 2;Neither satisfied nor dissatisfied(n=54,60) | 16 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 9; Extremely satisfied (n=49,56) | 8 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 2; Dissatisfied (n=54,60) | 2 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 7; Extremely satisfied (n=50,59) | 4 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 3; Extremely satisfied (n=54,60) | 4 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 3; Satisfied (n=54,60) | 39 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 7; Satisfied (n=50,59) | 35 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 3;Neither satisfied nor dissatisfied(n=54,60) | 12 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 9; Satisfied (n=49,56) | 25 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 3; Dissatisfied (n=54,60) | 5 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 7;Neither satisfied nor dissatisfied(n=50,59) | 14 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 4; Extremely satisfied (n=54,60) | 5 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 10/ED; Satisfied (n=54,60) | 33 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 4; Satisfied (n=54,60) | 33 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 7; Dissatisfied (n=50,59) | 6 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 4;Neither satisfied nor dissatisfied(n=54,60) | 19 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 9;Neither satisfied nor dissatisfied(n=49,56) | 16 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 4; Dissatisfied (n=54,60) | 3 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 8; Extremely satisfied (n=50,59) | 4 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 5; Extremely satisfied (n=51,60) | 4 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 10/ED; Dissatisfied (n=54,60) | 7 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 5; Satisfied (n=51,60) | 36 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 8; Satisfied (n=50,59) | 31 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 5;Neither satisfied nor dissatisfied(n=51,60) | 16 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 9; Dissatisfied (n=49,56) | 7 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 5; Dissatisfied (n=51,60) | 4 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase | Day 8;Neither satisfied nor dissatisfied(n=50,59) | 17 Participants |
Secondary
Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase
Participants were asked to assess their satisfaction with respect to the therapeutic efficacy (effectiveness) of the study drug to control pain 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 pre-application (PA), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12, Day 13 and Day 14 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 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 1 PA; Extremely satisfied (n=155) | 1 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 1 PA; Satisfied (n=155) | 9 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day1 PA;Neither satisfied nor dissatisfied(n=155) | 54 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 1 PA; Dissatisfied (n=155) | 83 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 1 PA; Extremely dissatisfied (n=155) | 8 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 2; Extremely satisfied (n=155) | 4 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 2; Satisfied (n=155) | 32 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 2; Neither satisfied nor dissatisfied (n=155) | 79 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 2; Dissatisfied (n=155) | 39 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 2; Extremely dissatisfied (n=155) | 1 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 3; Extremely satisfied (n=153) | 1 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 3; Satisfied (n=153) | 50 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 3; Neither satisfied nor dissatisfied (n=153) | 70 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 3; Dissatisfied (n=153) | 31 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 3; Extremely dissatisfied (n=153) | 1 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 4; Extremely satisfied (n=152) | 3 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 4; Neither satisfied nor dissatisfied (n=152) | 69 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 4; Dissatisfied (n=152) | 24 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 4; Extremely dissatisfied (n=152) | 1 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 5; Extremely satisfied (n=151) | 4 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 5; Satisfied (n=151) | 63 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 5; Neither satisfied nor dissatisfied (n=151) | 59 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 5; Dissatisfied (n=151) | 24 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 5; Extremely dissatisfied (n=151) | 1 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 6; Extremely satisfied (n=129) | 4 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 6; Dissatisfied (n=129) | 54 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 6; Extremely dissatisfied (n=129) | 51 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 6; Satisfied (n=129) | 19 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 6; Neither satisfied nor dissatisfied (n=129) | 1 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 7; Extremely satisfied (n=112) | 5 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 7; Satisfied (n=112) | 50 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 7; Neither satisfied nor dissatisfied (n=112) | 43 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 7; Dissatisfied (n=112) | 14 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 7; Extremely dissatisfied (n=112) | 0 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 8; Extremely satisfied (n=98) | 3 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 8; Satisfied (n=98) | 48 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 8; Neither satisfied nor dissatisfied (n=98) | 38 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 8; Dissatisfied (n=98) | 9 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 8; Extremely dissatisfied (n=98) | 0 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 9; Extremely satisfied (n=74) | 1 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 9; Satisfied (n=74) | 36 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 9; Neither satisfied nor dissatisfied (n=74) | 33 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 9; Dissatisfied (n=74) | 4 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 9; Extremely dissatisfied (n=74) | 0 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 10; Extremely satisfied (n=57) | 0 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 10; Satisfied (n=57) | 29 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 10; Neither satisfied nor dissatisfied (n=57) | 23 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 10; Dissatisfied (n=57) | 5 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 10; Extremely dissatisfied (n=57) | 0 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 11; Extremely satisfied (n=51) | 1 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 11; Satisfied (n=51) | 23 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 11; Neither satisfied nor dissatisfied (n=51) | 21 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 11; Dissatisfied (n=51) | 6 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 11; Extremely dissatisfied (n=51) | 0 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 12; Extremely satisfied (n=38) | 1 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 12; Satisfied (n=38) | 20 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 12; Neither satisfied nor dissatisfied (n=38) | 15 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 12; Dissatisfied (n=38) | 2 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 12; Extremely dissatisfied (n=38) | 0 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 13; Extremely satisfied (n=29) | 0 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 13; Satisfied (n=29) | 18 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 13; Neither satisfied nor dissatisfied (n=29) | 9 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 13; Dissatisfied (n=29) | 2 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 13; Extremely dissatisfied (n=29) | 0 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 14/ED; Extremely satisfied (n=155) | 9 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 14/ED; Satisfied (n=155) | 82 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day14/ED;Neither satisfied nor dissatisfied(n=155) | 53 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 14/ED; Dissatisfied (n=155) | 11 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 14/ED; Extremely dissatisfied (n=155) | 0 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase | Day 4; Satisfied (n=152) | 55 Participants |
Secondary
Number of Participants With Response Based on Physician's Global Assessment Scale in Double Blind Phase
The treating physician assessed the therapeutic efficacy of the study drug to control pain on a 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
Population: The PPS population included all the participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug excluding those with any major protocol deviation or other violations. 'n' signifies those participants who were evaluable for this measure at given time points.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Physician's Global Assessment Scale in Double Blind Phase | Effective | 53 Percentage of participants | 0.49 |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Physician's Global Assessment Scale in Double Blind Phase | Ineffective | 1 Percentage of participants | — |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Response Based on Physician's Global Assessment Scale in Double Blind Phase | Effective | 58 Percentage of participants | 0.82 |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Response Based on Physician's Global Assessment Scale in Double Blind Phase | Ineffective | 0 Percentage of participants | — |
Secondary
Number of Participants With Response Based on Physician's Global Assessment Scale in Titration Phase
The treating physician assessed the therapeutic efficacy of the study drug to control pain on a 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 14
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' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Physician's Global Assessment Scale in Titration Phase | Effective | 145 Participants | 0.64 |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Response Based on Physician's Global Assessment Scale in Titration Phase | Ineffective | 9 Participants | — |
Secondary
Number of Participants With Total Duration of Pain Per Day in Double Blind Phase
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 14-End of Titration Phase (ETP), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9 and Day 10 or ED
Population: The PPS population included all the participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug excluding those with any major protocol deviation or other violations. 'n' signifies those participants who were evaluable for this measure at given time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 3; >= 8 to < 12 hours (n=54,60) | 4 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | ETP; >= 4 to < 8 hours (n=54,60) | 5 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | ETP; >= 8 to < 12 hours (n=54,60) | 2 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | ETP; >= 12 hours (n=54,60) | 2 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | ETP; 24 hours (n=54,60) | 1 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 2; < 4 hours (n=54,60) | 40 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 2; >= 4 to < 8 hours (n=54,60) | 6 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 2; >= 8 to < 12 hours (n=54,60) | 4 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 2; >= 12 hours (n=54,60) | 3 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 2; 24 hours (n=54,60) | 1 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 3; < 4 hours (n=54,60) | 42 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 3; >= 4 to < 8 hours (n=54,60) | 5 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | ETP; < 4 hours (n=54,60) | 44 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 3; >= 12 hours (n=54,60) | 2 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 3; 24 hours (n=54,60) | 1 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 4; < 4 hours (n=54,60) | 39 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 4; >= 4 to < 8 hours (n=54,60) | 7 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 4; >= 8 to < 12 hours (n=54,60) | 4 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 4; >= 12 hours (n=54,60) | 1 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 4; 24 hours (n=54,60) | 3 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 5; < 4 hours (n=51,60) | 37 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 5; >= 4 to < 8 hours (n=51,60) | 7 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 5; >= 8 to < 12 hours (n=51,60) | 3 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 5; >= 12 hours (n=51,60) | 2 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 5; 24 hours (n=51,60) | 2 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 6; < 4 hours (n=50,60) | 35 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 6; >= 4 to < 8 hours (n=50,60) | 8 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 6; >= 8 to < 12 hours (n=50,60) | 2 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 6; >= 12 hours (n=50,60) | 4 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 6; 24 hours (n=50,60) | 1 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 7; < 4 hours (n=50,59) | 36 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 7; >= 4 to < 8 hours (n=50,59) | 9 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 7; >= 8 to < 12 hours (n=50,59) | 2 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 7; >= 12 hours (n=50,59) | 2 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 7; 24 hours (n=50,59) | 1 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 8; < 4 hours (n=50,59) | 38 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 8; >= 4 to < 8 hours (n=50,59) | 7 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 8; >= 8 to < 12 hours (n=50,59) | 4 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 8; >= 12 hours (n=50,59) | 1 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 8; 24 hours (n=50,59) | 0 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 9; < 4 hours (n=49,56) | 37 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 9; >= 4 to < 8 hours (n=49,56) | 7 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 9; >= 8 to < 12 hours (n=49,56) | 4 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 9; >= 12 hours (n=49,56) | 1 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 9; 24 hours (n=49,56) | 0 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 10 or ED; < 4 hours (n=54,60) | 42 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 10 or ED; >= 4 to < 8 hours (n=54,60) | 5 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 10 or ED; >= 8 to < 12 hours (n=54,60) | 6 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 10 or ED; >= 12 hours (n=54,60) | 1 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 10 or ED; 24 hours (n=54,60) | 0 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 8; >= 8 to < 12 hours (n=50,59) | 4 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | ETP; < 4 hours (n=54,60) | 46 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 6; < 4 hours (n=50,60) | 48 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | ETP; >= 4 to < 8 hours (n=54,60) | 5 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 10 or ED; >= 12 hours (n=54,60) | 5 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | ETP; >= 8 to < 12 hours (n=54,60) | 7 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 6; >= 4 to < 8 hours (n=50,60) | 6 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | ETP; >= 12 hours (n=54,60) | 1 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 8; >= 12 hours (n=50,59) | 4 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | ETP; 24 hours (n=54,60) | 1 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 6; >= 8 to < 12 hours (n=50,60) | 3 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 2; < 4 hours (n=54,60) | 48 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 9; 24 hours (n=49,56) | 1 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 2; >= 4 to < 8 hours (n=54,60) | 3 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 6; >= 12 hours (n=50,60) | 2 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 2; >= 8 to < 12 hours (n=54,60) | 7 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 8; 24 hours (n=50,59) | 1 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 2; >= 12 hours (n=54,60) | 1 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 6; 24 hours (n=50,60) | 1 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 2; 24 hours (n=54,60) | 1 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 10 or ED; >= 8 to < 12 hours (n=54,60) | 2 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 3; < 4 hours (n=54,60) | 46 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 7; < 4 hours (n=50,59) | 46 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 3; >= 4 to < 8 hours (n=54,60) | 6 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 9; < 4 hours (n=49,56) | 44 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 3; >= 8 to < 12 hours (n=54,60) | 5 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 7; >= 4 to < 8 hours (n=50,59) | 6 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 3; >= 12 hours (n=54,60) | 1 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 10 or ED; < 4 hours (n=54,60) | 46 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 3; 24 hours (n=54,60) | 2 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 7; >= 8 to < 12 hours (n=50,59) | 2 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 4; < 4 hours (n=54,60) | 43 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 9; >= 4 to < 8 hours (n=49,56) | 7 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 4; >= 4 to < 8 hours (n=54,60) | 10 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 7; >= 12 hours (n=50,59) | 3 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 4; >= 8 to < 12 hours (n=54,60) | 3 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 10 or ED; 24 hours (n=54,60) | 1 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 4; >= 12 hours (n=54,60) | 3 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 7; 24 hours (n=50,59) | 2 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 4; 24 hours (n=54,60) | 1 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 9; >= 8 to < 12 hours (n=49,56) | 2 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 5; < 4 hours (n=51,60) | 45 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 8; < 4 hours (n=50,59) | 46 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 5; >= 4 to < 8 hours (n=51,60) | 8 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 10 or ED; >= 4 to < 8 hours (n=54,60) | 6 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 5; >= 8 to < 12 hours (n=51,60) | 4 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 8; >= 4 to < 8 hours (n=50,59) | 4 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 5; >= 12 hours (n=51,60) | 2 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 9; >= 12 hours (n=49,56) | 2 Participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Number of Participants With Total Duration of Pain Per Day in Double Blind Phase | Day 5; 24 hours (n=51,60) | 1 Participants |
Secondary
Number of Participants With Total Duration of Pain Per Day in Titration Phase
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 PA, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12, Day 13 and Day 14 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 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 1 PA; < 4 hours (n=155) | 36 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 1 PA; >= 4 to < 8 hours (n=155) | 38 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 1 PA; >= 8 to < 12 hours (n=155) | 22 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 1 PA; >= 12 hours (n=155) | 24 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 1 PA; 24 hours (n=155) | 35 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 2; < 4 hours (n=155) | 52 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 2; >= 4 to < 8 hours (n=155) | 31 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 2; >= 8 to < 12 hours (n=155) | 30 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 2; >= 12 hours (n=155) | 17 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 2; 24 hours (n=155) | 25 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 3; < 4 hours (n=153) | 63 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 3; >= 4 to < 8 hours (n=153) | 32 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 3; >= 8 to < 12 hours (n=153) | 26 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 3; >= 12 hours (n=153) | 12 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 3; 24 hours (n=153) | 20 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 4; < 4 hours (n=152) | 81 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 4; >= 4 to < 8 hours (n=152) | 26 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 4; >= 8 to < 12 hours (n=152) | 19 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 4; >= 12 hours (n=152) | 13 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 4; 24 hours (n=152) | 13 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 5; < 4 hours (n=151) | 86 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 5; >= 4 to < 8 hours (n=151) | 24 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 5; >= 8 to < 12 hours (n=151) | 15 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 5; >= 12 hours (n=151) | 14 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 5; 24 hours (n=151) | 12 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 6; < 4 hours (n=129) | 72 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 6; >= 4 to < 8 hours (n=129) | 20 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 6; >= 8 to < 12 hours (n=129) | 13 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 6; >= 12 hours (n=129) | 12 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 6; 24 hours (n=129) | 12 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 7; < 4 hours (n=112) | 66 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 7; >= 4 to < 8 hours (n=112) | 18 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 7; >= 8 to < 12 hours (n=112) | 12 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 7; >= 12 hours (n=112) | 7 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 7; 24 hours (n=112) | 9 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 8; < 4 hours (n=98) | 55 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 8; >= 4 to < 8 hours (n=98) | 18 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 8; >= 8 to < 12 hours (n=98) | 12 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 8; >= 12 hours (n=98) | 6 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 8; 24 hours (n=98) | 7 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 9; < 4 hours (n=74) | 44 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 9; >= 4 to < 8 hours (n=74) | 12 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 9; >= 8 to < 12 hours (n=74) | 6 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 9; >= 12 hours (n=74) | 4 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 9; 24 hours (n=74) | 8 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 10; < 4 hours (n=57) | 31 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 10; >= 4 to < 8 hours (n=57) | 9 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 10; >= 8 to < 12 hours (n=57) | 5 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 10; >= 12 hours (n=57) | 4 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 10; 24 hours (n=57) | 8 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 11; < 4 hours (n=51) | 35 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 11; >= 4 to < 8 hours (n=51) | 2 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 11; >= 8 to < 12 hours (n=51) | 8 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 11; >= 12 hours (n=51) | 1 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 11; 24 hours (n=51) | 5 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 12; < 4 hours (n=38) | 25 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 12; >= 4 to < 8 hours (n=38) | 2 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 12; >= 8 to < 12 hours (n=38) | 7 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 12; >= 12 hours (n=38) | 2 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 12; 24 hours (n=38) | 2 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 13; < 4 hours (n=29) | 17 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 13; >= 4 to < 8 hours (n=29) | 3 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 13; >= 8 to < 12 hours (n=29) | 4 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 13; >= 12 hours (n=29) | 3 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 13; 24 hours (n=29) | 2 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 14 or ED; < 4 hours (n=155) | 107 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 14 or ED; >= 4 to < 8 hours (n=155) | 16 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 14 or ED; >= 8 to < 12 hours (n=155) | 15 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 14 or ED; >= 12 hours (n=155) | 9 Participants |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Number of Participants With Total Duration of Pain Per Day in Titration Phase | Day 14 or ED; 24 hours (n=155) | 8 Participants |
Secondary
Pain Intensity Visual Analog Scale (VAS) Score in Double Blind Phase
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 14-End of Titration Phase (ETP), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9 and Day 10 or ED
Population: The PPS population included all the participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug excluding those with any major protocol deviation or other violations. 'n' signifies those participants who were evaluable for this measure at given time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Pain Intensity Visual Analog Scale (VAS) Score in Double Blind Phase | ETP; (n=54,60) | 16.5 mm | Standard Deviation 9.34 |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Pain Intensity Visual Analog Scale (VAS) Score in Double Blind Phase | Day 2; (n=54,60) | 18.2 mm | Standard Deviation 11.31 |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Pain Intensity Visual Analog Scale (VAS) Score in Double Blind Phase | Day 3; (n=54,60) | 21.5 mm | Standard Deviation 19.56 |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Pain Intensity Visual Analog Scale (VAS) Score in Double Blind Phase | Day 4; (n=54,60) | 17.2 mm | Standard Deviation 14.09 |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Pain Intensity Visual Analog Scale (VAS) Score in Double Blind Phase | Day 5; (n=51,60) | 16.8 mm | Standard Deviation 14.43 |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Pain Intensity Visual Analog Scale (VAS) Score in Double Blind Phase | Day 6; (n=50,60) | 18.1 mm | Standard Deviation 16.08 |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Pain Intensity Visual Analog Scale (VAS) Score in Double Blind Phase | Day 7; (n=50,59) | 16.3 mm | Standard Deviation 14.33 |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Pain Intensity Visual Analog Scale (VAS) Score in Double Blind Phase | Day 8; (n=50,59) | 17.5 mm | Standard Deviation 16.71 |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Pain Intensity Visual Analog Scale (VAS) Score in Double Blind Phase | Day 9; (n=49,56) | 17.0 mm | Standard Deviation 18.1 |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Pain Intensity Visual Analog Scale (VAS) Score in Double Blind Phase | Day 10 or ED; (n=54,60) | 16.1 mm | Standard Deviation 16.1 |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Pain Intensity Visual Analog Scale (VAS) Score in Double Blind Phase | Day 8; (n=50,59) | 17.2 mm | Standard Deviation 12.29 |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Pain Intensity Visual Analog Scale (VAS) Score in Double Blind Phase | ETP; (n=54,60) | 18.6 mm | Standard Deviation 9.88 |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Pain Intensity Visual Analog Scale (VAS) Score in Double Blind Phase | Day 6; (n=50,60) | 19.2 mm | Standard Deviation 12.88 |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Pain Intensity Visual Analog Scale (VAS) Score in Double Blind Phase | Day 2; (n=54,60) | 18.4 mm | Standard Deviation 10.68 |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Pain Intensity Visual Analog Scale (VAS) Score in Double Blind Phase | Day 10 or ED; (n=54,60) | 18.8 mm | Standard Deviation 15.7 |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Pain Intensity Visual Analog Scale (VAS) Score in Double Blind Phase | Day 3; (n=54,60) | 17.8 mm | Standard Deviation 10.15 |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Pain Intensity Visual Analog Scale (VAS) Score in Double Blind Phase | Day 7; (n=50,59) | 18.0 mm | Standard Deviation 13.03 |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Pain Intensity Visual Analog Scale (VAS) Score in Double Blind Phase | Day 4; (n=54,60) | 18.5 mm | Standard Deviation 12.37 |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Pain Intensity Visual Analog Scale (VAS) Score in Double Blind Phase | Day 9; (n=49,56) | 17.2 mm | Standard Deviation 11.97 |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Pain Intensity Visual Analog Scale (VAS) Score in Double Blind Phase | Day 5; (n=51,60) | 17.7 mm | Standard Deviation 11.95 |
Secondary
Pain Intensity Visual Analog Scale (VAS) Score in Titration Phase
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 PA, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12, Day 13 and Day 14 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 1-day Transdermal Patch (Titration Phase) | Pain Intensity Visual Analog Scale (VAS) Score in Titration Phase | Day 1 PA (n=155) | 56.8 mm | Standard Deviation 16.28 |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Pain Intensity Visual Analog Scale (VAS) Score in Titration Phase | Day 2 (n=155) | 45.0 mm | Standard Deviation 18.93 |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Pain Intensity Visual Analog Scale (VAS) Score in Titration Phase | Day 3 (n=153) | 41.9 mm | Standard Deviation 22.11 |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Pain Intensity Visual Analog Scale (VAS) Score in Titration Phase | Day 4 (n=152) | 35.7 mm | Standard Deviation 19.43 |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Pain Intensity Visual Analog Scale (VAS) Score in Titration Phase | Day 5 (n=151) | 32.7 mm | Standard Deviation 18.25 |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Pain Intensity Visual Analog Scale (VAS) Score in Titration Phase | Day 6 (n=129) | 32.8 mm | Standard Deviation 19.15 |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Pain Intensity Visual Analog Scale (VAS) Score in Titration Phase | Day 7 (n=111) | 30.5 mm | Standard Deviation 15.92 |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Pain Intensity Visual Analog Scale (VAS) Score in Titration Phase | Day 8 (n=98) | 29.2 mm | Standard Deviation 15.4 |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Pain Intensity Visual Analog Scale (VAS) Score in Titration Phase | Day 9 (n=74) | 29.0 mm | Standard Deviation 15.6 |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Pain Intensity Visual Analog Scale (VAS) Score in Titration Phase | Day 10 (n=57) | 28.5 mm | Standard Deviation 15.35 |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Pain Intensity Visual Analog Scale (VAS) Score in Titration Phase | Day 11 (n=51) | 25.8 mm | Standard Deviation 15.34 |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Pain Intensity Visual Analog Scale (VAS) Score in Titration Phase | Day 12 (n=38) | 27.4 mm | Standard Deviation 17.93 |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Pain Intensity Visual Analog Scale (VAS) Score in Titration Phase | Day 13 (n=29) | 27.5 mm | Standard Deviation 16.34 |
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Pain Intensity Visual Analog Scale (VAS) Score in Titration Phase | Day 14 or ED (n=155) | 23.8 mm | Standard Deviation 17.57 |
Secondary
Percentage of Participants Achieving Pain Control in Double Blind Phase
Pain control was assessed based on change in VAS and number of daily rescue doses during 3 days before completion of Double Blind Phase from 3 days before start of Double Blind Phase. For VAS score, difference of less than or equal to +15 mm and for rescue doses, difference of less than or equal to 1 was considered significant to achieve pain control. Pain Intensity VAS measured pain severity on a scale ranging from 0 mm (no pain) to 100 mm (severest pain conceivable) and rescue dose was defined as dose of fast-acting oral morphine formulation used in case of breakthrough pain.
Time frame: Day 10 or ED
Population: The PPS population included all the participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug excluding those with any major protocol deviation or other violations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fentanyl 1-day Transdermal Patch (Titration Phase) | Percentage of Participants Achieving Pain Control in Double Blind Phase | 83.3 Percentage of participants |
| Fentanyl 3-day Transdermal Patch (Double Blind Phase) | Percentage of Participants Achieving Pain Control in Double Blind Phase | 90.0 Percentage of participants |