Trial Outcomes & Findings for A Dose-Finding Study of Fentanyl (JNS020 QD) 1-Day Transdermal Patch in Participants With Cancer Pain (NCT NCT00644787)
NCT ID: NCT00644787
Last Updated: 2013-06-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
156 participants
Primary outcome timeframe
Day 14 or early discontinuation (ED)
Results posted on
2013-06-13
Participant Flow
Participant milestones
| Measure |
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.
|
Fentanyl 1-day Transdermal Patch (Double Blind Phase)
Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application (JNS005) transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
|
Fentanyl 3-day Transdermal Patch (Double Blind Phase)
Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
|
|---|---|---|---|
|
Period 1: Titration Phase
STARTED
|
156
|
0
|
0
|
|
Period 1: Titration Phase
COMPLETED
|
129
|
0
|
0
|
|
Period 1: Titration Phase
NOT COMPLETED
|
27
|
0
|
0
|
|
Period 2: Double Blind Phase
STARTED
|
0
|
58
|
62
|
|
Period 2: Double Blind Phase
COMPLETED
|
0
|
49
|
55
|
|
Period 2: Double Blind Phase
NOT COMPLETED
|
0
|
9
|
7
|
Reasons for withdrawal
| Measure |
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.
|
Fentanyl 1-day Transdermal Patch (Double Blind Phase)
Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application (JNS005) transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
|
Fentanyl 3-day Transdermal Patch (Double Blind Phase)
Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
|
|---|---|---|---|
|
Period 1: Titration Phase
Adverse Event
|
11
|
0
|
0
|
|
Period 1: Titration Phase
Withdrawal by Subject
|
2
|
0
|
0
|
|
Period 1: Titration Phase
Physician Decision
|
1
|
0
|
0
|
|
Period 1: Titration Phase
Worsening of underlying disease
|
5
|
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
Dose adjustment required on Day 12 or 13
|
3
|
0
|
0
|
|
Period 1: Titration Phase
Participant was judged as ineligible
|
3
|
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 underlying disease
|
0
|
6
|
2
|
|
Period 2: Double Blind Phase
Worsening of symptoms
|
0
|
0
|
1
|
Baseline Characteristics
A Dose-Finding Study of Fentanyl (JNS020 QD) 1-Day Transdermal Patch in Participants With Cancer Pain
Baseline characteristics by cohort
| Measure |
Fentanyl 1-day Transdermal Patch (Titration Phase)
n=155 Participants
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.
|
|---|---|
|
Age Continuous
|
68.7 Years
STANDARD_DEVIATION 9.52 • n=93 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
94 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Fentanyl 1-day Transdermal Patch (Titration Phase)
n=155 Participants
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.
|
Fentanyl 3-day Transdermal Patch (Double Blind Phase)
Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
|
|---|---|---|
|
Percentage of Participants Achieving Dose Titration Success
|
80.60 Percentage of participants
Interval 73.5 to 86.5
|
—
|
PRIMARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
Fentanyl 1-day Transdermal Patch (Titration Phase)
n=54 Participants
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.
|
Fentanyl 3-day Transdermal Patch (Double Blind Phase)
n=60 Participants
Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
|
|---|---|---|
|
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
|
20.6 mm
Standard Deviation 8.58
|
|
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
|
-2.5 mm
Standard Deviation 11.32
|
SECONDARY outcome
Timeframe: 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 EDPopulation: 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.
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.
Outcome measures
| Measure |
Fentanyl 1-day Transdermal Patch (Titration Phase)
n=155 Participants
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.
|
Fentanyl 3-day Transdermal Patch (Double Blind Phase)
Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
|
|---|---|---|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase
Day 1 PA; Extremely satisfied (n=155)
|
1 Participants
Interval 3.1 to 11.5
|
—
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase
Day 1 PA; Satisfied (n=155)
|
9 Participants
Interval 50.5 to 66.5
|
—
|
|
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
|
—
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase
Day 1 PA; Dissatisfied (n=155)
|
83 Participants
|
—
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase
Day 1 PA; Extremely dissatisfied (n=155)
|
8 Participants
|
—
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase
Day 2; Extremely satisfied (n=155)
|
4 Participants
|
—
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase
Day 2; Satisfied (n=155)
|
32 Participants
|
—
|
|
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
|
—
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase
Day 2; Dissatisfied (n=155)
|
39 Participants
|
—
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase
Day 2; Extremely dissatisfied (n=155)
|
1 Participants
|
—
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase
Day 3; Extremely satisfied (n=153)
|
1 Participants
|
—
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase
Day 3; Satisfied (n=153)
|
50 Participants
|
—
|
|
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
|
—
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase
Day 3; Dissatisfied (n=153)
|
31 Participants
|
—
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase
Day 3; Extremely dissatisfied (n=153)
|
1 Participants
|
—
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase
Day 4; Extremely satisfied (n=152)
|
3 Participants
|
—
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase
Day 4; Satisfied (n=152)
|
55 Participants
|
—
|
|
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
|
—
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase
Day 4; Dissatisfied (n=152)
|
24 Participants
|
—
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase
Day 4; Extremely dissatisfied (n=152)
|
1 Participants
|
—
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase
Day 5; Extremely satisfied (n=151)
|
4 Participants
|
—
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase
Day 5; Satisfied (n=151)
|
63 Participants
|
—
|
|
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
|
—
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase
Day 5; Dissatisfied (n=151)
|
24 Participants
|
—
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase
Day 5; Extremely dissatisfied (n=151)
|
1 Participants
|
—
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase
Day 6; Extremely satisfied (n=129)
|
4 Participants
|
—
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase
Day 6; Dissatisfied (n=129)
|
54 Participants
|
—
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase
Day 6; Extremely dissatisfied (n=129)
|
51 Participants
|
—
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase
Day 6; Satisfied (n=129)
|
19 Participants
|
—
|
|
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
|
—
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase
Day 7; Extremely satisfied (n=112)
|
5 Participants
|
—
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase
Day 7; Satisfied (n=112)
|
50 Participants
|
—
|
|
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
|
—
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase
Day 7; Dissatisfied (n=112)
|
14 Participants
|
—
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase
Day 7; Extremely dissatisfied (n=112)
|
0 Participants
|
—
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase
Day 8; Extremely satisfied (n=98)
|
3 Participants
|
—
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase
Day 8; Satisfied (n=98)
|
48 Participants
|
—
|
|
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
|
—
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase
Day 8; Dissatisfied (n=98)
|
9 Participants
|
—
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase
Day 8; Extremely dissatisfied (n=98)
|
0 Participants
|
—
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase
Day 9; Extremely satisfied (n=74)
|
1 Participants
|
—
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase
Day 9; Satisfied (n=74)
|
36 Participants
|
—
|
|
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
|
—
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase
Day 9; Dissatisfied (n=74)
|
4 Participants
|
—
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase
Day 9; Extremely dissatisfied (n=74)
|
0 Participants
|
—
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase
Day 10; Extremely satisfied (n=57)
|
0 Participants
|
—
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase
Day 10; Satisfied (n=57)
|
29 Participants
|
—
|
|
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
|
—
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase
Day 10; Dissatisfied (n=57)
|
5 Participants
|
—
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase
Day 10; Extremely dissatisfied (n=57)
|
0 Participants
|
—
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase
Day 11; Extremely satisfied (n=51)
|
1 Participants
|
—
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase
Day 11; Satisfied (n=51)
|
23 Participants
|
—
|
|
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
|
—
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase
Day 11; Dissatisfied (n=51)
|
6 Participants
|
—
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase
Day 11; Extremely dissatisfied (n=51)
|
0 Participants
|
—
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase
Day 12; Extremely satisfied (n=38)
|
1 Participants
|
—
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase
Day 12; Satisfied (n=38)
|
20 Participants
|
—
|
|
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
|
—
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase
Day 12; Dissatisfied (n=38)
|
2 Participants
|
—
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase
Day 12; Extremely dissatisfied (n=38)
|
0 Participants
|
—
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase
Day 13; Extremely satisfied (n=29)
|
0 Participants
|
—
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase
Day 13; Satisfied (n=29)
|
18 Participants
|
—
|
|
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
|
—
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase
Day 13; Dissatisfied (n=29)
|
2 Participants
|
—
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase
Day 13; Extremely dissatisfied (n=29)
|
0 Participants
|
—
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase
Day 14/ED; Extremely satisfied (n=155)
|
9 Participants
|
—
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase
Day 14/ED; Satisfied (n=155)
|
82 Participants
|
—
|
|
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
|
—
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase
Day 14/ED; Dissatisfied (n=155)
|
11 Participants
|
—
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Titration Phase
Day 14/ED; Extremely dissatisfied (n=155)
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 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 EDPopulation: 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.
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.
Outcome measures
| Measure |
Fentanyl 1-day Transdermal Patch (Titration Phase)
n=54 Participants
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.
|
Fentanyl 3-day Transdermal Patch (Double Blind Phase)
n=60 Participants
Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
|
|---|---|---|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase
Day 8; Dissatisfied (n=50,59)
|
1 Participants
|
7 Participants
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase
ETP; Extremely satisfied (n=54,60)
|
3 Participants
Interval 48.7 to 75.7
|
4 Participants
Interval 55.0 to 79.7
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase
ETP; Satisfied (n=54,60)
|
31 Participants
Interval 50.6 to 77.3
|
37 Participants
Interval 46.5 to 72.4
|
|
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
|
16 Participants
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase
ETP; Dissatisfied (n=54,60)
|
1 Participants
|
3 Participants
|
|
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
|
4 Participants
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase
Day 2; Satisfied (n=54,60)
|
33 Participants
|
38 Participants
|
|
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
|
16 Participants
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase
Day 2; Dissatisfied (n=54,60)
|
2 Participants
|
2 Participants
|
|
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
|
4 Participants
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase
Day 3; Satisfied (n=54,60)
|
32 Participants
|
39 Participants
|
|
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
|
12 Participants
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase
Day 3; Dissatisfied (n=54,60)
|
3 Participants
|
5 Participants
|
|
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
|
5 Participants
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase
Day 4; Satisfied (n=54,60)
|
31 Participants
|
33 Participants
|
|
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
|
19 Participants
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase
Day 4; Dissatisfied (n=54,60)
|
3 Participants
|
3 Participants
|
|
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
|
4 Participants
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase
Day 5; Satisfied (n=51,60)
|
28 Participants
|
36 Participants
|
|
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
|
16 Participants
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase
Day 5; Dissatisfied (n=51,60)
|
1 Participants
|
4 Participants
|
|
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
|
6 Participants
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase
Day 6; Satisfied (n=50,60)
|
25 Participants
|
34 Participants
|
|
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
|
15 Participants
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase
Day 6; Dissatisfied (n=50,60)
|
2 Participants
|
5 Participants
|
|
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
|
4 Participants
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase
Day 7; Satisfied (n=50,59)
|
27 Participants
|
35 Participants
|
|
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
|
14 Participants
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase
Day 7; Dissatisfied (n=50,59)
|
0 Participants
|
6 Participants
|
|
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
|
4 Participants
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase
Day 8; Satisfied (n=50,59)
|
25 Participants
|
31 Participants
|
|
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
|
17 Participants
|
|
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
|
8 Participants
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase
Day 9; Satisfied (n=49,56)
|
22 Participants
|
25 Participants
|
|
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
|
16 Participants
|
|
Number of Participants With Response Based on Participant's Global Assessment Scale in Double Blind Phase
Day 9; Dissatisfied (n=49,56)
|
0 Participants
|
7 Participants
|
|
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
|
3 Participants
|
|
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
|
33 Participants
|
|
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
|
17 Participants
|
|
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
|
7 Participants
|
SECONDARY outcome
Timeframe: 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 EDPopulation: 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.
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".
Outcome measures
| Measure |
Fentanyl 1-day Transdermal Patch (Titration Phase)
n=155 Participants
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.
|
Fentanyl 3-day Transdermal Patch (Double Blind Phase)
Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
|
|---|---|---|
|
Pain Intensity Visual Analog Scale (VAS) Score in Titration Phase
Day 1 PA (n=155)
|
56.8 mm
Standard Deviation 16.28
|
—
|
|
Pain Intensity Visual Analog Scale (VAS) Score in Titration Phase
Day 2 (n=155)
|
45.0 mm
Standard Deviation 18.93
|
—
|
|
Pain Intensity Visual Analog Scale (VAS) Score in Titration Phase
Day 3 (n=153)
|
41.9 mm
Standard Deviation 22.11
|
—
|
|
Pain Intensity Visual Analog Scale (VAS) Score in Titration Phase
Day 4 (n=152)
|
35.7 mm
Standard Deviation 19.43
|
—
|
|
Pain Intensity Visual Analog Scale (VAS) Score in Titration Phase
Day 5 (n=151)
|
32.7 mm
Standard Deviation 18.25
|
—
|
|
Pain Intensity Visual Analog Scale (VAS) Score in Titration Phase
Day 6 (n=129)
|
32.8 mm
Standard Deviation 19.15
|
—
|
|
Pain Intensity Visual Analog Scale (VAS) Score in Titration Phase
Day 7 (n=111)
|
30.5 mm
Standard Deviation 15.92
|
—
|
|
Pain Intensity Visual Analog Scale (VAS) Score in Titration Phase
Day 8 (n=98)
|
29.2 mm
Standard Deviation 15.40
|
—
|
|
Pain Intensity Visual Analog Scale (VAS) Score in Titration Phase
Day 9 (n=74)
|
29.0 mm
Standard Deviation 15.60
|
—
|
|
Pain Intensity Visual Analog Scale (VAS) Score in Titration Phase
Day 10 (n=57)
|
28.5 mm
Standard Deviation 15.35
|
—
|
|
Pain Intensity Visual Analog Scale (VAS) Score in Titration Phase
Day 11 (n=51)
|
25.8 mm
Standard Deviation 15.34
|
—
|
|
Pain Intensity Visual Analog Scale (VAS) Score in Titration Phase
Day 12 (n=38)
|
27.4 mm
Standard Deviation 17.93
|
—
|
|
Pain Intensity Visual Analog Scale (VAS) Score in Titration Phase
Day 13 (n=29)
|
27.5 mm
Standard Deviation 16.34
|
—
|
|
Pain Intensity Visual Analog Scale (VAS) Score in Titration Phase
Day 14 or ED (n=155)
|
23.8 mm
Standard Deviation 17.57
|
—
|
SECONDARY outcome
Timeframe: 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 EDPopulation: 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.
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".
Outcome measures
| Measure |
Fentanyl 1-day Transdermal Patch (Titration Phase)
n=54 Participants
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.
|
Fentanyl 3-day Transdermal Patch (Double Blind Phase)
n=60 Participants
Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
|
|---|---|---|
|
Pain Intensity Visual Analog Scale (VAS) Score in Double Blind Phase
ETP; (n=54,60)
|
16.5 mm
Standard Deviation 9.34
|
18.6 mm
Standard Deviation 9.88
|
|
Pain Intensity Visual Analog Scale (VAS) Score in Double Blind Phase
Day 2; (n=54,60)
|
18.2 mm
Standard Deviation 11.31
|
18.4 mm
Standard Deviation 10.68
|
|
Pain Intensity Visual Analog Scale (VAS) Score in Double Blind Phase
Day 3; (n=54,60)
|
21.5 mm
Standard Deviation 19.56
|
17.8 mm
Standard Deviation 10.15
|
|
Pain Intensity Visual Analog Scale (VAS) Score in Double Blind Phase
Day 4; (n=54,60)
|
17.2 mm
Standard Deviation 14.09
|
18.5 mm
Standard Deviation 12.37
|
|
Pain Intensity Visual Analog Scale (VAS) Score in Double Blind Phase
Day 5; (n=51,60)
|
16.8 mm
Standard Deviation 14.43
|
17.7 mm
Standard Deviation 11.95
|
|
Pain Intensity Visual Analog Scale (VAS) Score in Double Blind Phase
Day 6; (n=50,60)
|
18.1 mm
Standard Deviation 16.08
|
19.2 mm
Standard Deviation 12.88
|
|
Pain Intensity Visual Analog Scale (VAS) Score in Double Blind Phase
Day 7; (n=50,59)
|
16.3 mm
Standard Deviation 14.33
|
18.0 mm
Standard Deviation 13.03
|
|
Pain Intensity Visual Analog Scale (VAS) Score in Double Blind Phase
Day 8; (n=50,59)
|
17.5 mm
Standard Deviation 16.71
|
17.2 mm
Standard Deviation 12.29
|
|
Pain Intensity Visual Analog Scale (VAS) Score in Double Blind Phase
Day 9; (n=49,56)
|
17.0 mm
Standard Deviation 18.10
|
17.2 mm
Standard Deviation 11.97
|
|
Pain Intensity Visual Analog Scale (VAS) Score in Double Blind Phase
Day 10 or ED; (n=54,60)
|
16.1 mm
Standard Deviation 16.10
|
18.8 mm
Standard Deviation 15.70
|
SECONDARY outcome
Timeframe: Day 10 or EDPopulation: 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.
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.
Outcome measures
| Measure |
Fentanyl 1-day Transdermal Patch (Titration Phase)
n=54 Participants
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.
|
Fentanyl 3-day Transdermal Patch (Double Blind Phase)
n=60 Participants
Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
|
|---|---|---|
|
Percentage of Participants Achieving Pain Control in Double Blind Phase
|
83.3 Percentage of participants
Interval 70.7 to 92.1
|
90.0 Percentage of participants
Interval 79.5 to 96.2
|
SECONDARY outcome
Timeframe: 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 EDPopulation: 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.
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.
Outcome measures
| Measure |
Fentanyl 1-day Transdermal Patch (Titration Phase)
n=155 Participants
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.
|
Fentanyl 3-day Transdermal Patch (Double Blind Phase)
Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
|
|---|---|---|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase
Day 1 PA; No pain (n=155)
|
0 Participants
|
—
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase
Day 1 PA; Mild pain (n=155)
|
23 Participants
|
—
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase
Day 1 PA; moderate Pain (n=155)
|
115 Participants
|
—
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase
Day 1 PA; severe Pain (n=155)
|
17 Participants
|
—
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase
Day 2; No pain (n=155)
|
4 Participants
|
—
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase
Day 2; Mild pain (n=155)
|
54 Participants
|
—
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase
Day 2; Moderate pain (n=155)
|
93 Participants
|
—
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase
Day 2; Severe pain (n=155)
|
4 Participants
|
—
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase
Day 3; No pain (n=153)
|
13 Participants
|
—
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase
Day 3; Mild pain (n=153)
|
64 Participants
|
—
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase
Day 3; Moderate pain (n=153)
|
69 Participants
|
—
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase
Day 3; Severe pain (n=153)
|
7 Participants
|
—
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase
Day 4; No pain (n=152)
|
12 Participants
|
—
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase
Day 4; Mild pain (n=152)
|
68 Participants
|
—
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase
Day 4; Moderate pain (n=152)
|
70 Participants
|
—
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase
Day 4; Severe pain (n=152)
|
2 Participants
|
—
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase
Day 5; No pain (n=151)
|
15 Participants
|
—
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase
Day 5; Mild pain (n=151)
|
80 Participants
|
—
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase
Day 5; Moderate pain (n=151)
|
50 Participants
|
—
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase
Day 5; Severe pain (n=151)
|
6 Participants
|
—
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase
Day 6; No pain (n=129)
|
13 Participants
|
—
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase
Day 6; Mild pain (n=129)
|
69 Participants
|
—
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase
Day 6; Moderate pain (n=129)
|
44 Participants
|
—
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase
Day 6; Severe pain (n=129)
|
3 Participants
|
—
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase
Day 7; No pain (n=112)
|
11 Participants
|
—
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase
Day 7; Mild pain (n=112)
|
62 Participants
|
—
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase
Day 7; Moderate pain (n=112)
|
36 Participants
|
—
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase
Day 7; Severe pain (n=112)
|
3 Participants
|
—
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase
Day 8; No pain (n=98)
|
9 Participants
|
—
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase
Day 8; Mild pain (n=98)
|
56 Participants
|
—
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase
Day 8; Moderate pain (n=98)
|
28 Participants
|
—
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase
Day 8; Severe pain (n=98)
|
5 Participants
|
—
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase
Day 9; No pain (n=74)
|
7 Participants
|
—
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase
Day 9; Mild pain (n=74)
|
45 Participants
|
—
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase
Day 9; Moderate pain (n=74)
|
22 Participants
|
—
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase
Day 9; Severe pain (n=74)
|
0 Participants
|
—
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase
Day 10; No pain (n=57)
|
3 Participants
|
—
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase
Day 10; Mild pain (n=57)
|
31 Participants
|
—
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase
Day 10; Moderate pain (n=57)
|
23 Participants
|
—
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase
Day 10; Severe pain (n=57)
|
0 Participants
|
—
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase
Day 11; No pain (n=51)
|
5 Participants
|
—
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase
Day 11; Mild pain (n=51)
|
27 Participants
|
—
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase
Day 11; Moderate pain (n=51)
|
18 Participants
|
—
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase
Day 11; Severe pain (n=51)
|
1 Participants
|
—
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase
Day 12; No pain (n=38)
|
5 Participants
|
—
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase
Day 12; Mild pain (n=38)
|
21 Participants
|
—
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase
Day 12; Moderate pain (n=38)
|
11 Participants
|
—
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase
Day 12; Severe pain (n=38)
|
1 Participants
|
—
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase
Day 13; No pain (n=29)
|
2 Participants
|
—
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase
Day 13; Mild pain (n=29)
|
15 Participants
|
—
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase
Day 13; Moderate pain (n=29)
|
12 Participants
|
—
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Titration Phase
Day 13; Severe pain (n=29)
|
0 Participants
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
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 outcome
Timeframe: 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 EDPopulation: 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.
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.
Outcome measures
| Measure |
Fentanyl 1-day Transdermal Patch (Titration Phase)
n=54 Participants
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.
|
Fentanyl 3-day Transdermal Patch (Double Blind Phase)
n=60 Participants
Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
|
|---|---|---|
|
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
|
12 Participants
|
|
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
|
2 Participants
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase
ETP; No pain (n=54,60)
|
6 Participants
|
10 Participants
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase
ETP; MIld pain (n=54,60)
|
39 Participants
|
37 Participants
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase
ETP; Moderate pain (n=54,60)
|
9 Participants
|
12 Participants
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain in Double Blind Phase
ETP; Severe pain (n=54,60)
|
0 Participants
|
1 Participants
|
|
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
|
9 Participants
|
|
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
|
40 Participants
|
|
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
|
11 Participants
|
|
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
|
0 Participants
|
|
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
|
12 Participants
|
|
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
|
39 Participants
|
|
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
|
8 Participants
|
|
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
|
1 Participants
|
|
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
|
12 Participants
|
|
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
|
41 Participants
|
|
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
|
7 Participants
|
|
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
|
0 Participants
|
|
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
|
11 Participants
|
|
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
|
42 Participants
|
|
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
|
7 Participants
|
|
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
|
0 Participants
|
|
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
|
11 Participants
|
|
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
|
34 Participants
|
|
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
|
14 Participants
|
|
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
|
1 Participants
|
|
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
|
11 Participants
|
|
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
|
34 Participants
|
|
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
|
10 Participants
|
|
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
|
36 Participants
|
|
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
|
13 Participants
|
|
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
|
0 Participants
|
|
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
|
10 Participants
|
|
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
|
33 Participants
|
|
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
|
13 Participants
|
|
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
|
0 Participants
|
|
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
|
11 Participants
|
|
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
|
30 Participants
|
|
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
|
18 Participants
|
|
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
|
1 Participants
|
SECONDARY outcome
Timeframe: 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 EDPopulation: 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.
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).
Outcome measures
| Measure |
Fentanyl 1-day Transdermal Patch (Titration Phase)
n=155 Participants
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.
|
Fentanyl 3-day Transdermal Patch (Double Blind Phase)
Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
|
|---|---|---|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 8; >= 4 to < 8 hours (n=98)
|
18 Participants
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 8; >= 8 to < 12 hours (n=98)
|
12 Participants
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 8; >= 12 hours (n=98)
|
6 Participants
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 8; 24 hours (n=98)
|
7 Participants
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 9; < 4 hours (n=74)
|
44 Participants
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 9; >= 4 to < 8 hours (n=74)
|
12 Participants
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 9; >= 8 to < 12 hours (n=74)
|
6 Participants
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 9; >= 12 hours (n=74)
|
4 Participants
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 1 PA; < 4 hours (n=155)
|
36 Participants
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 1 PA; >= 4 to < 8 hours (n=155)
|
38 Participants
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 1 PA; >= 8 to < 12 hours (n=155)
|
22 Participants
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 1 PA; >= 12 hours (n=155)
|
24 Participants
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 1 PA; 24 hours (n=155)
|
35 Participants
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 2; < 4 hours (n=155)
|
52 Participants
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 2; >= 4 to < 8 hours (n=155)
|
31 Participants
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 2; >= 8 to < 12 hours (n=155)
|
30 Participants
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 2; >= 12 hours (n=155)
|
17 Participants
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 2; 24 hours (n=155)
|
25 Participants
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 3; < 4 hours (n=153)
|
63 Participants
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 3; >= 4 to < 8 hours (n=153)
|
32 Participants
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 3; >= 8 to < 12 hours (n=153)
|
26 Participants
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 3; >= 12 hours (n=153)
|
12 Participants
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 3; 24 hours (n=153)
|
20 Participants
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 4; < 4 hours (n=152)
|
81 Participants
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 4; >= 4 to < 8 hours (n=152)
|
26 Participants
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 4; >= 8 to < 12 hours (n=152)
|
19 Participants
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 4; >= 12 hours (n=152)
|
13 Participants
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 4; 24 hours (n=152)
|
13 Participants
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 5; < 4 hours (n=151)
|
86 Participants
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 5; >= 4 to < 8 hours (n=151)
|
24 Participants
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 5; >= 8 to < 12 hours (n=151)
|
15 Participants
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 5; >= 12 hours (n=151)
|
14 Participants
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 5; 24 hours (n=151)
|
12 Participants
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 6; < 4 hours (n=129)
|
72 Participants
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 6; >= 4 to < 8 hours (n=129)
|
20 Participants
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 6; >= 8 to < 12 hours (n=129)
|
13 Participants
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 6; >= 12 hours (n=129)
|
12 Participants
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 6; 24 hours (n=129)
|
12 Participants
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 7; < 4 hours (n=112)
|
66 Participants
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 7; >= 4 to < 8 hours (n=112)
|
18 Participants
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 7; >= 8 to < 12 hours (n=112)
|
12 Participants
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 7; >= 12 hours (n=112)
|
7 Participants
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 7; 24 hours (n=112)
|
9 Participants
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 8; < 4 hours (n=98)
|
55 Participants
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 9; 24 hours (n=74)
|
8 Participants
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 10; < 4 hours (n=57)
|
31 Participants
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 10; >= 4 to < 8 hours (n=57)
|
9 Participants
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 10; >= 8 to < 12 hours (n=57)
|
5 Participants
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 10; >= 12 hours (n=57)
|
4 Participants
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 10; 24 hours (n=57)
|
8 Participants
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 11; < 4 hours (n=51)
|
35 Participants
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 11; >= 4 to < 8 hours (n=51)
|
2 Participants
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 11; >= 8 to < 12 hours (n=51)
|
8 Participants
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 11; >= 12 hours (n=51)
|
1 Participants
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 11; 24 hours (n=51)
|
5 Participants
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 12; < 4 hours (n=38)
|
25 Participants
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 12; >= 4 to < 8 hours (n=38)
|
2 Participants
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 12; >= 8 to < 12 hours (n=38)
|
7 Participants
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 12; >= 12 hours (n=38)
|
2 Participants
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 12; 24 hours (n=38)
|
2 Participants
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 13; < 4 hours (n=29)
|
17 Participants
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 13; >= 4 to < 8 hours (n=29)
|
3 Participants
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 13; >= 8 to < 12 hours (n=29)
|
4 Participants
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 13; >= 12 hours (n=29)
|
3 Participants
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 13; 24 hours (n=29)
|
2 Participants
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 14 or ED; < 4 hours (n=155)
|
107 Participants
|
—
|
|
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
|
—
|
|
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
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 14 or ED; >= 12 hours (n=155)
|
9 Participants
|
—
|
|
Number of Participants With Total Duration of Pain Per Day in Titration Phase
Day 14 or ED; 24 hours (n=155)
|
8 Participants
|
—
|
SECONDARY outcome
Timeframe: 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 EDPopulation: 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.
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).
Outcome measures
| Measure |
Fentanyl 1-day Transdermal Patch (Titration Phase)
n=54 Participants
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.
|
Fentanyl 3-day Transdermal Patch (Double Blind Phase)
n=60 Participants
Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
|
|---|---|---|
|
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
|
3 Participants
|
|
Number of Participants With Total Duration of Pain Per Day in Double Blind Phase
Day 6; >= 12 hours (n=50,60)
|
4 Participants
|
2 Participants
|
|
Number of Participants With Total Duration of Pain Per Day in Double Blind Phase
ETP; < 4 hours (n=54,60)
|
44 Participants
|
46 Participants
|
|
Number of Participants With Total Duration of Pain Per Day in Double Blind Phase
ETP; >= 4 to < 8 hours (n=54,60)
|
5 Participants
|
5 Participants
|
|
Number of Participants With Total Duration of Pain Per Day in Double Blind Phase
ETP; >= 8 to < 12 hours (n=54,60)
|
2 Participants
|
7 Participants
|
|
Number of Participants With Total Duration of Pain Per Day in Double Blind Phase
ETP; >= 12 hours (n=54,60)
|
2 Participants
|
1 Participants
|
|
Number of Participants With Total Duration of Pain Per Day in Double Blind Phase
ETP; 24 hours (n=54,60)
|
1 Participants
|
1 Participants
|
|
Number of Participants With Total Duration of Pain Per Day in Double Blind Phase
Day 2; < 4 hours (n=54,60)
|
40 Participants
|
48 Participants
|
|
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
|
3 Participants
|
|
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
|
7 Participants
|
|
Number of Participants With Total Duration of Pain Per Day in Double Blind Phase
Day 2; >= 12 hours (n=54,60)
|
3 Participants
|
1 Participants
|
|
Number of Participants With Total Duration of Pain Per Day in Double Blind Phase
Day 2; 24 hours (n=54,60)
|
1 Participants
|
1 Participants
|
|
Number of Participants With Total Duration of Pain Per Day in Double Blind Phase
Day 3; < 4 hours (n=54,60)
|
42 Participants
|
46 Participants
|
|
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
|
6 Participants
|
|
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
|
5 Participants
|
|
Number of Participants With Total Duration of Pain Per Day in Double Blind Phase
Day 3; >= 12 hours (n=54,60)
|
2 Participants
|
1 Participants
|
|
Number of Participants With Total Duration of Pain Per Day in Double Blind Phase
Day 3; 24 hours (n=54,60)
|
1 Participants
|
2 Participants
|
|
Number of Participants With Total Duration of Pain Per Day in Double Blind Phase
Day 4; < 4 hours (n=54,60)
|
39 Participants
|
43 Participants
|
|
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
|
10 Participants
|
|
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
|
3 Participants
|
|
Number of Participants With Total Duration of Pain Per Day in Double Blind Phase
Day 4; >= 12 hours (n=54,60)
|
1 Participants
|
3 Participants
|
|
Number of Participants With Total Duration of Pain Per Day in Double Blind Phase
Day 4; 24 hours (n=54,60)
|
3 Participants
|
1 Participants
|
|
Number of Participants With Total Duration of Pain Per Day in Double Blind Phase
Day 5; < 4 hours (n=51,60)
|
37 Participants
|
45 Participants
|
|
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
|
8 Participants
|
|
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
|
4 Participants
|
|
Number of Participants With Total Duration of Pain Per Day in Double Blind Phase
Day 5; >= 12 hours (n=51,60)
|
2 Participants
|
2 Participants
|
|
Number of Participants With Total Duration of Pain Per Day in Double Blind Phase
Day 5; 24 hours (n=51,60)
|
2 Participants
|
1 Participants
|
|
Number of Participants With Total Duration of Pain Per Day in Double Blind Phase
Day 6; < 4 hours (n=50,60)
|
35 Participants
|
48 Participants
|
|
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
|
6 Participants
|
|
Number of Participants With Total Duration of Pain Per Day in Double Blind Phase
Day 6; 24 hours (n=50,60)
|
1 Participants
|
1 Participants
|
|
Number of Participants With Total Duration of Pain Per Day in Double Blind Phase
Day 7; < 4 hours (n=50,59)
|
36 Participants
|
46 Participants
|
|
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
|
6 Participants
|
|
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
|
2 Participants
|
|
Number of Participants With Total Duration of Pain Per Day in Double Blind Phase
Day 7; >= 12 hours (n=50,59)
|
2 Participants
|
3 Participants
|
|
Number of Participants With Total Duration of Pain Per Day in Double Blind Phase
Day 7; 24 hours (n=50,59)
|
1 Participants
|
2 Participants
|
|
Number of Participants With Total Duration of Pain Per Day in Double Blind Phase
Day 8; < 4 hours (n=50,59)
|
38 Participants
|
46 Participants
|
|
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
|
4 Participants
|
|
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
|
4 Participants
|
|
Number of Participants With Total Duration of Pain Per Day in Double Blind Phase
Day 8; >= 12 hours (n=50,59)
|
1 Participants
|
4 Participants
|
|
Number of Participants With Total Duration of Pain Per Day in Double Blind Phase
Day 8; 24 hours (n=50,59)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Total Duration of Pain Per Day in Double Blind Phase
Day 9; < 4 hours (n=49,56)
|
37 Participants
|
44 Participants
|
|
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
|
7 Participants
|
|
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
|
2 Participants
|
|
Number of Participants With Total Duration of Pain Per Day in Double Blind Phase
Day 9; >= 12 hours (n=49,56)
|
1 Participants
|
2 Participants
|
|
Number of Participants With Total Duration of Pain Per Day in Double Blind Phase
Day 9; 24 hours (n=49,56)
|
0 Participants
|
1 Participants
|
|
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
|
46 Participants
|
|
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
|
6 Participants
|
|
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
|
2 Participants
|
|
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
|
5 Participants
|
|
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
|
1 Participants
|
SECONDARY outcome
Timeframe: 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 EDPopulation: 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.
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.
Outcome measures
| Measure |
Fentanyl 1-day Transdermal Patch (Titration Phase)
n=155 Participants
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.
|
Fentanyl 3-day Transdermal Patch (Double Blind Phase)
Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
|
|---|---|---|
|
Mean Number of Rescue Doses in Titration Phase
Day 1 PA; (n=155)
|
0.3 Rescue doses
Standard Deviation 0.64
|
—
|
|
Mean Number of Rescue Doses in Titration Phase
Day 2; (n=155)
|
0.8 Rescue doses
Standard Deviation 1.17
|
—
|
|
Mean Number of Rescue Doses in Titration Phase
Day 3; (n=153)
|
0.7 Rescue doses
Standard Deviation 1.03
|
—
|
|
Mean Number of Rescue Doses in Titration Phase
Day 4; (n=152)
|
0.6 Rescue doses
Standard Deviation 1.04
|
—
|
|
Mean Number of Rescue Doses in Titration Phase
Day 5; (n=151)
|
0.5 Rescue doses
Standard Deviation 0.70
|
—
|
|
Mean Number of Rescue Doses in Titration Phase
Day 6; (n=129)
|
0.7 Rescue doses
Standard Deviation 0.93
|
—
|
|
Mean Number of Rescue Doses in Titration Phase
Day 7; (n=112)
|
0.5 Rescue doses
Standard Deviation 0.82
|
—
|
|
Mean Number of Rescue Doses in Titration Phase
Day 8; (n=99)
|
0.5 Rescue doses
Standard Deviation 0.86
|
—
|
|
Mean Number of Rescue Doses in Titration Phase
Day 9; (n=74)
|
0.4 Rescue doses
Standard Deviation 0.66
|
—
|
|
Mean Number of Rescue Doses in Titration Phase
Day 10; (n=57)
|
0.4 Rescue doses
Standard Deviation 0.75
|
—
|
|
Mean Number of Rescue Doses in Titration Phase
Day 11; (n=51)
|
0.4 Rescue doses
Standard Deviation 0.85
|
—
|
|
Mean Number of Rescue Doses in Titration Phase
Day 12; (n=38)
|
0.5 Rescue doses
Standard Deviation 0.83
|
—
|
|
Mean Number of Rescue Doses in Titration Phase
Day 13; (n=29)
|
0.3 Rescue doses
Standard Deviation 0.60
|
—
|
|
Mean Number of Rescue Doses in Titration Phase
Day 14 or ED; (n=155)
|
0.2 Rescue doses
Standard Deviation 0.52
|
—
|
SECONDARY outcome
Timeframe: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9 and Day 10 or EDPopulation: 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.
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.
Outcome measures
| Measure |
Fentanyl 1-day Transdermal Patch (Titration Phase)
n=54 Participants
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.
|
Fentanyl 3-day Transdermal Patch (Double Blind Phase)
n=60 Participants
Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
|
|---|---|---|
|
Mean Number of Rescue Doses in Double Blind Phase
Day 1; (n=54,60)
|
0.1 Rescue doses
Standard Deviation 0.41
|
0.2 Rescue doses
Standard Deviation 0.44
|
|
Mean Number of Rescue Doses in Double Blind Phase
Day 2; (54,60)
|
0.3 Rescue doses
Standard Deviation 0.63
|
0.4 Rescue doses
Standard Deviation 0.74
|
|
Mean Number of Rescue Doses in Double Blind Phase
Day 3; (54,60)
|
0.3 Rescue doses
Standard Deviation 0.70
|
0.4 Rescue doses
Standard Deviation 0.79
|
|
Mean Number of Rescue Doses in Double Blind Phase
Day 4; (54,60)
|
0.4 Rescue doses
Standard Deviation 0.70
|
0.4 Rescue doses
Standard Deviation 0.79
|
|
Mean Number of Rescue Doses in Double Blind Phase
Day 5; (52,60)
|
0.3 Rescue doses
Standard Deviation 0.70
|
0.5 Rescue doses
Standard Deviation 0.75
|
|
Mean Number of Rescue Doses in Double Blind Phase
Day 6; (50,60)
|
0.3 Rescue doses
Standard Deviation 0.71
|
0.6 Rescue doses
Standard Deviation 0.87
|
|
Mean Number of Rescue Doses in Double Blind Phase
Day 7; (50,59)
|
0.3 Rescue doses
Standard Deviation 0.65
|
0.5 Rescue doses
Standard Deviation 1.04
|
|
Mean Number of Rescue Doses in Double Blind Phase
Day 8; (50,59)
|
0.5 Rescue doses
Standard Deviation 0.93
|
0.5 Rescue doses
Standard Deviation 0.90
|
|
Mean Number of Rescue Doses in Double Blind Phase
Day 9; (49,56)
|
0.5 Rescue doses
Standard Deviation 1.10
|
0.5 Rescue doses
Standard Deviation 0.79
|
|
Mean Number of Rescue Doses in Double Blind Phase
Day 10 or ED; (54,60)
|
0.2 Rescue doses
Standard Deviation 0.49
|
0.4 Rescue doses
Standard Deviation 0.82
|
SECONDARY outcome
Timeframe: Day 14Population: 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.
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.
Outcome measures
| Measure |
Fentanyl 1-day Transdermal Patch (Titration Phase)
n=154 Participants
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.
|
Fentanyl 3-day Transdermal Patch (Double Blind Phase)
Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
|
|---|---|---|
|
Number of Participants With Response Based on Physician's Global Assessment Scale in Titration Phase
Effective
|
145 Participants
0.64
|
—
|
|
Number of Participants With Response Based on Physician's Global Assessment Scale in Titration Phase
Ineffective
|
9 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 10Population: 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.
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.
Outcome measures
| Measure |
Fentanyl 1-day Transdermal Patch (Titration Phase)
n=54 Participants
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.
|
Fentanyl 3-day Transdermal Patch (Double Blind Phase)
n=58 Participants
Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
|
|---|---|---|
|
Number of Participants With Response Based on Physician's Global Assessment Scale in Double Blind Phase
Effective
|
53 Percentage of participants
0.49
|
58 Percentage of participants
0.82
|
|
Number of Participants With Response Based on Physician's Global Assessment Scale in Double Blind Phase
Ineffective
|
1 Percentage of participants
|
0 Percentage of participants
|
Adverse Events
Fentanyl 1-day Transdermal Patch (Titration Phase)
Serious events: 14 serious events
Other events: 128 other events
Deaths: 0 deaths
Fentanyl 1-day Transdermal Patch (Double Blind Phase)
Serious events: 9 serious events
Other events: 47 other events
Deaths: 0 deaths
Fentanyl 3-day Transdermal Patch (Double Blind Phase)
Serious events: 11 serious events
Other events: 48 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fentanyl 1-day Transdermal Patch (Titration Phase)
n=155 participants at risk
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.
|
Fentanyl 1-day Transdermal Patch (Double Blind Phase)
n=57 participants at risk
Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application (JNS005) transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
|
Fentanyl 3-day Transdermal Patch (Double Blind Phase)
n=62 participants at risk
Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
|
|---|---|---|---|
|
Infections and infestations
Sepsis
|
0.65%
1/155 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
0.00%
0/57 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
0.00%
0/62 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
1.3%
2/155 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
1.8%
1/57 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
0.00%
0/62 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.65%
1/155 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
0.00%
0/57 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
1.6%
1/62 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
1.3%
2/155 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
1.8%
1/57 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
1.6%
1/62 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.65%
1/155 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
0.00%
0/57 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
0.00%
0/62 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.65%
1/155 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
0.00%
0/57 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
0.00%
0/62 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
1.3%
2/155 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
0.00%
0/57 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
0.00%
0/62 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.65%
1/155 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
1.8%
1/57 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
0.00%
0/62 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
1.3%
2/155 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
0.00%
0/57 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
0.00%
0/62 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.65%
1/155 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
0.00%
0/57 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
0.00%
0/62 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.65%
1/155 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
0.00%
0/57 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
0.00%
0/62 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
1.9%
3/155 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
1.8%
1/57 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
0.00%
0/62 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
|
Gastrointestinal disorders
Vomiting
|
0.65%
1/155 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
0.00%
0/57 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
1.6%
1/62 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/155 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
0.00%
0/57 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
1.6%
1/62 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/155 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
0.00%
0/57 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
3.2%
2/62 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/155 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
0.00%
0/57 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
1.6%
1/62 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/155 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
0.00%
0/57 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
1.6%
1/62 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/155 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
0.00%
0/57 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
1.6%
1/62 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
|
Metabolism and nutrition disorders
Oral intake reduced
|
0.00%
0/155 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
0.00%
0/57 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
1.6%
1/62 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/155 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
1.8%
1/57 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
0.00%
0/62 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/155 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
1.8%
1/57 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
0.00%
0/62 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/155 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
0.00%
0/57 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
1.6%
1/62 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/155 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
1.8%
1/57 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
0.00%
0/62 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/155 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
1.8%
1/57 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
0.00%
0/62 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/155 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
0.00%
0/57 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
1.6%
1/62 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/155 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
1.8%
1/57 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
3.2%
2/62 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/155 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
1.8%
1/57 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
0.00%
0/62 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
Other adverse events
| Measure |
Fentanyl 1-day Transdermal Patch (Titration Phase)
n=155 participants at risk
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.
|
Fentanyl 1-day Transdermal Patch (Double Blind Phase)
n=57 participants at risk
Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 1-day application transdermal patch and placebo matched to fentanyl 3-day application (JNS005) transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
|
Fentanyl 3-day Transdermal Patch (Double Blind Phase)
n=62 participants at risk
Participants who met the predefined criteria at the end of Titration Phase and entered the Double Blind Phase received fentanyl 3-day application transdermal patch and placebo matched to fentanyl 1-day application transdermal patch applied once daily releasing the drug at the same dose as maintained at the end of Titration Phase with maximum applied dose of 100 mcg/hr for 10 days.
|
|---|---|---|---|
|
Nervous system disorders
Somnolence
|
60.0%
93/155 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
59.6%
34/57 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
58.1%
36/62 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
|
Gastrointestinal disorders
Constipation
|
50.3%
78/155 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
54.4%
31/57 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
58.1%
36/62 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
|
Gastrointestinal disorders
Diarrhoea
|
7.1%
11/155 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
14.0%
8/57 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
21.0%
13/62 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
|
Gastrointestinal disorders
Nausea
|
47.7%
74/155 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
56.1%
32/57 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
54.8%
34/62 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
|
Gastrointestinal disorders
Vomiting
|
29.0%
45/155 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
29.8%
17/57 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
37.1%
23/62 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
7.1%
11/155 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
7.0%
4/57 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
8.1%
5/62 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.1%
11/155 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
10.5%
6/57 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
8.1%
5/62 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
|
General disorders
Application site erythema
|
7.7%
12/155 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
12.3%
7/57 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
11.3%
7/62 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
|
General disorders
Application site pruritus
|
6.5%
10/155 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
7.0%
4/57 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
3.2%
2/62 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
|
General disorders
Pyrexia
|
7.7%
12/155 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
10.5%
6/57 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
8.1%
5/62 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/155 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
1.8%
1/57 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
6.5%
4/62 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/155 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
5.3%
3/57 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
1.6%
1/62 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/155 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
5.3%
3/57 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
0.00%
0/62 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
|
Psychiatric disorders
Delirium
|
0.00%
0/155 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
8.8%
5/57 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
6.5%
4/62 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/155 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
8.8%
5/57 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
4.8%
3/62 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/155 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
7.0%
4/57 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
0.00%
0/62 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/155 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
5.3%
3/57 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
3.2%
2/62 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/155 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
7.0%
4/57 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
9.7%
6/62 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
|
General disorders
Malaise
|
0.00%
0/155 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
5.3%
3/57 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
3.2%
2/62 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
|
Investigations
Blood urea increased
|
0.00%
0/155 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
5.3%
3/57 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
1.6%
1/62 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
|
Investigations
Platelet count decreased
|
0.00%
0/155 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
5.3%
3/57 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
1.6%
1/62 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
|
Investigations
White blood cell count decreased
|
0.00%
0/155 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
5.3%
3/57 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
6.5%
4/62 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
|
Investigations
White blood cell count increased
|
0.00%
0/155 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
10.5%
6/57 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
0.00%
0/62 • From signing of the informed consent up to 7 days after the completion or discontinuation of study treatment.
Safety set included 155 participants in Dose Titration Phase, 57 participants in Fentanyl 1-day transdermal patch (Double Blind Phase) and 62 participants in Fentanyl 3-day transdermal patch (Double Blind Phase).
|
Additional Information
Director, Clinical Research
Janssen Research & Development, L.L.C. USA
Phone: 1 609 730-3387
Results disclosure agreements
- Principal investigator is a sponsor employee The disclosure restriction on PI is that the Sponsor can review results communications prior to public release and can embargo communications regarding results for a period as the Sponsor requires.
- Publication restrictions are in place
Restriction type: OTHER