Trial Outcomes & Findings for An Efficacy and Safety Study of Fentanyl (JNS020QD) in Participants With Cancer Pain (NCT NCT00641667)
NCT ID: NCT00641667
Last Updated: 2013-06-07
Results Overview
Pain control was assessed based on change in Visual Analog Scale (VAS) and number of daily rescue doses during 3 days before completion of study drug from 3 days before start of study drug. For VAS score, a difference of less than or equal to +15 millimeter (mm) and for rescue doses, a difference of less than or equal to 1 was considered significant to achieve pain control. Pain Intensity VAS ranged from 0 mm (no pain) to 100 mm (severest pain conceivable) and rescue dose was defined as dose of fast-acting opioid analgesic (except fentanyl preparations) used for lack of analgesic effect.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
66 participants
Primary outcome timeframe
Day 10 or early discontinuation (ED)
Results posted on
2013-06-07
Participant Flow
Participant milestones
| Measure |
Fentanyl
Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator's discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).
|
|---|---|
|
Overall Study
STARTED
|
66
|
|
Overall Study
COMPLETED
|
60
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Fentanyl
Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator's discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Worsening of underlying disease
|
3
|
Baseline Characteristics
An Efficacy and Safety Study of Fentanyl (JNS020QD) in Participants With Cancer Pain
Baseline characteristics by cohort
| Measure |
Fentanyl
n=66 Participants
Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator's discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).
|
|---|---|
|
Age Continuous
|
63.80 Years
STANDARD_DEVIATION 12.67 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 10 or early discontinuation (ED)Population: Full Analysis Set (FAS) population included all participants who applied at least 1 study drug patch and had 1 VAS assessment performed after application of the study drug.
Pain control was assessed based on change in Visual Analog Scale (VAS) and number of daily rescue doses during 3 days before completion of study drug from 3 days before start of study drug. For VAS score, a difference of less than or equal to +15 millimeter (mm) and for rescue doses, a difference of less than or equal to 1 was considered significant to achieve pain control. Pain Intensity VAS ranged from 0 mm (no pain) to 100 mm (severest pain conceivable) and rescue dose was defined as dose of fast-acting opioid analgesic (except fentanyl preparations) used for lack of analgesic effect.
Outcome measures
| Measure |
Fentanyl
n=66 Participants
Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator's discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).
|
|---|---|
|
Percentage of Participants Achieving Pain Control
|
81.8 Percentage of Participants
Interval 70.4 to 90.2
|
SECONDARY outcome
Timeframe: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 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 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
n=66 Participants
Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator's discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).
|
|---|---|
|
Number of Participants With Response Based on Patient's Global Assessment Scale
Day 1; Extremely satisfied (n=66)
|
8 Participants
|
|
Number of Participants With Response Based on Patient's Global Assessment Scale
Day 1; Satisfied (n=66)
|
35 Participants
|
|
Number of Participants With Response Based on Patient's Global Assessment Scale
Day 1; Neither satisfied nor dissatisfied (n=66)
|
19 Participants
|
|
Number of Participants With Response Based on Patient's Global Assessment Scale
Day 2; Neither satisfied nor dissatisfied (n=65)
|
24 Participants
|
|
Number of Participants With Response Based on Patient's Global Assessment Scale
Day 2; Dissatisfied (n=65)
|
2 Participants
|
|
Number of Participants With Response Based on Patient's Global Assessment Scale
Day 2; Extremely dissatisfied (n=65)
|
0 Participants
|
|
Number of Participants With Response Based on Patient's Global Assessment Scale
Day 3; Extremely satisfied (n=65)
|
8 Participants
|
|
Number of Participants With Response Based on Patient's Global Assessment Scale
Day 5; Extremely dissatisfied (n=63)
|
1 Participants
|
|
Number of Participants With Response Based on Patient's Global Assessment Scale
Day 6; Extremely satisfied (n=63)
|
9 Participants
|
|
Number of Participants With Response Based on Patient's Global Assessment Scale
Day 8; Neither satisfied nor dissatisfied (n=62)
|
19 Participants
|
|
Number of Participants With Response Based on Patient's Global Assessment Scale
Day 9; Neither satisfied nor dissatisfied (n=62)
|
17 Participants
|
|
Number of Participants With Response Based on Patient's Global Assessment Scale
Day 1; Dissatisfied (n=66)
|
4 Participants
|
|
Number of Participants With Response Based on Patient's Global Assessment Scale
Day 1; Extremely dissatisfied (n=66)
|
0 Participants
|
|
Number of Participants With Response Based on Patient's Global Assessment Scale
Day 2; Extremely satisfied (n=65)
|
8 Participants
|
|
Number of Participants With Response Based on Patient's Global Assessment Scale
Day 2; Satisfied (n=65)
|
31 Participants
|
|
Number of Participants With Response Based on Patient's Global Assessment Scale
Day 3; Satisfied (n=65)
|
25 Participants
|
|
Number of Participants With Response Based on Patient's Global Assessment Scale
Day 3; Neither satisfied nor dissatisfied (n=65)
|
25 Participants
|
|
Number of Participants With Response Based on Patient's Global Assessment Scale
Day 3; Dissatisfied (n=65)
|
7 Participants
|
|
Number of Participants With Response Based on Patient's Global Assessment Scale
Day 3; Extremely dissatisfied (n=65)
|
0 Participants
|
|
Number of Participants With Response Based on Patient's Global Assessment Scale
Day 4; Extremely satisfied (n=64)
|
9 Participants
|
|
Number of Participants With Response Based on Patient's Global Assessment Scale
Day 4; Satisfied (n=64)
|
28 Participants
|
|
Number of Participants With Response Based on Patient's Global Assessment Scale
Day 4; Neither satisfied nor dissatisfied (n=64)
|
24 Participants
|
|
Number of Participants With Response Based on Patient's Global Assessment Scale
Day 4; Dissatisfied (n=64)
|
3 Participants
|
|
Number of Participants With Response Based on Patient's Global Assessment Scale
Day 4; Extremely dissatisfied (n=64)
|
0 Participants
|
|
Number of Participants With Response Based on Patient's Global Assessment Scale
Day 5; Extremely satisfied (n=63)
|
10 Participants
|
|
Number of Participants With Response Based on Patient's Global Assessment Scale
Day 5; Satisfied (n=63)
|
30 Participants
|
|
Number of Participants With Response Based on Patient's Global Assessment Scale
Day 5; Neither satisfied nor dissatisfied (n=63)
|
19 Participants
|
|
Number of Participants With Response Based on Patient's Global Assessment Scale
Day 5; Dissatisfied (n=63)
|
3 Participants
|
|
Number of Participants With Response Based on Patient's Global Assessment Scale
Day 6; Satisfied (n=63)
|
31 Participants
|
|
Number of Participants With Response Based on Patient's Global Assessment Scale
Day 6; Neither satisfied nor dissatisfied (n=63)
|
20 Participants
|
|
Number of Participants With Response Based on Patient's Global Assessment Scale
Day 6; Dissatisfied (n=63)
|
3 Participants
|
|
Number of Participants With Response Based on Patient's Global Assessment Scale
Day 6; Extremely dissatisfied (n=63)
|
0 Participants
|
|
Number of Participants With Response Based on Patient's Global Assessment Scale
Day 7; Extremely satisfied (n=63)
|
10 Participants
|
|
Number of Participants With Response Based on Patient's Global Assessment Scale
Day 7; Satisfied (n=63)
|
31 Participants
|
|
Number of Participants With Response Based on Patient's Global Assessment Scale
Day 7; Neither satisfied nor dissatisfied (n=63)
|
18 Participants
|
|
Number of Participants With Response Based on Patient's Global Assessment Scale
Day 7; Dissatisfied (n=63)
|
4 Participants
|
|
Number of Participants With Response Based on Patient's Global Assessment Scale
Day 7; Extremely dissatisfied (n=63)
|
0 Participants
|
|
Number of Participants With Response Based on Patient's Global Assessment Scale
Day 8; Extremely satisfied (n=62)
|
10 Participants
|
|
Number of Participants With Response Based on Patient's Global Assessment Scale
Day 8; Satisfied (n=62)
|
30 Participants
|
|
Number of Participants With Response Based on Patient's Global Assessment Scale
Day 8; Dissatisfied (n=62)
|
3 Participants
|
|
Number of Participants With Response Based on Patient's Global Assessment Scale
Day 8; Extremely dissatisfied (n=62)
|
0 Participants
|
|
Number of Participants With Response Based on Patient's Global Assessment Scale
Day 9; Extremely satisfied (n=62)
|
11 Participants
|
|
Number of Participants With Response Based on Patient's Global Assessment Scale
Day 9; Satisfied (n=62)
|
32 Participants
|
|
Number of Participants With Response Based on Patient's Global Assessment Scale
Day 9; Dissatisfied (n=62)
|
2 Participants
|
|
Number of Participants With Response Based on Patient's Global Assessment Scale
Day 9; Extremely dissatisfied (n=62)
|
0 Participants
|
|
Number of Participants With Response Based on Patient's Global Assessment Scale
Day 10/ED; Extremely satisfied (n=66)
|
10 Participants
|
|
Number of Participants With Response Based on Patient's Global Assessment Scale
Day 10/ED; Satisfied (n=66)
|
30 Participants
|
|
Number of Participants With Response Based on Patient's Global Assessment Scale
Day 10/ED;Neither satisfied nor dissatisfied(n=66)
|
20 Participants
|
|
Number of Participants With Response Based on Patient's Global Assessment Scale
Day 10/ED; Dissatisfied (n=66)
|
6 Participants
|
|
Number of Participants With Response Based on Patient's Global Assessment Scale
Day 10/ED; Extremely dissatisfied (n=66)
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 (pre-application), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 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
n=66 Participants
Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator's discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).
|
|---|---|
|
Pain Intensity Visual Analog Scale (VAS) Score
Day 1 pre-application; (n=66)
|
15.6 mm
Standard Deviation 11.77
|
|
Pain Intensity Visual Analog Scale (VAS) Score
Day 2; (n=65)
|
16.1 mm
Standard Deviation 11.95
|
|
Pain Intensity Visual Analog Scale (VAS) Score
Day 3; (n=65)
|
18.6 mm
Standard Deviation 15.84
|
|
Pain Intensity Visual Analog Scale (VAS) Score
Day 4; (n=64)
|
15.1 mm
Standard Deviation 13.09
|
|
Pain Intensity Visual Analog Scale (VAS) Score
Day 5; (n=63)
|
15.2 mm
Standard Deviation 14.31
|
|
Pain Intensity Visual Analog Scale (VAS) Score
Day 6; (n=63)
|
15.3 mm
Standard Deviation 12.68
|
|
Pain Intensity Visual Analog Scale (VAS) Score
Day 7; (n=63)
|
14.7 mm
Standard Deviation 13.47
|
|
Pain Intensity Visual Analog Scale (VAS) Score
Day 8; (n=62)
|
14.9 mm
Standard Deviation 14.34
|
|
Pain Intensity Visual Analog Scale (VAS) Score
Day 9; (n=62)
|
15.1 mm
Standard Deviation 13.38
|
|
Pain Intensity Visual Analog Scale (VAS) Score
Day 10 or ED; (n=66)
|
15.5 mm
Standard Deviation 13.34
|
SECONDARY outcome
Timeframe: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 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
n=66 Participants
Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator's discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).
|
|---|---|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain
Day 10 or ED; Severe pain(n=66)
|
3 Participants
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain
Day 1; No pain (n=66)
|
12 Participants
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain
Day 1; Mild pain (n=66)
|
37 Participants
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain
Day 1; Moderate pain (n=66)
|
17 Participants
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain
Day 1; Severe pain (n=66)
|
0 Participants
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain
Day 2; No pain (n=65)
|
10 Participants
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain
Day 2; Mild pain (n=65)
|
34 Participants
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain
Day 2; Moderate pain (n=65)
|
21 Participants
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain
Day 2; Severe pain (n=65)
|
0 Participants
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain
Day 3; No pain (n=65)
|
14 Participants
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain
Day 3; Mild pain (n=65)
|
33 Participants
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain
Day 3; Moderate pain (n=65)
|
15 Participants
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain
Day 3; Severe pain (n=65)
|
3 Participants
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain
Day 4; No pain (n=64)
|
16 Participants
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain
Day 4; Mild pain (n=64)
|
34 Participants
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain
Day 4; Moderate pain (n=64)
|
13 Participants
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain
Day 4; Severe pain (n=64)
|
1 Participants
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain
Day 5; No pain (n=63)
|
15 Participants
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain
Day 5; Mild pain (n=63)
|
36 Participants
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain
Day 5; Moderate pain (n=63)
|
12 Participants
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain
Day 5; Severe pain (n=63)
|
0 Participants
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain
Day 6; No pain (n=63)
|
16 Participants
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain
Day 6; Mild pain (n=63)
|
38 Participants
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain
Day 6; Moderate pain (n=63)
|
8 Participants
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain
Day 6; Severe pain (n=63)
|
1 Participants
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain
Day 7; No pain (n=63)
|
14 Participants
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain
Day 7; Mild pain (n=63)
|
38 Participants
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain
Day 7; Moderate pain (n=63)
|
11 Participants
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain
Day 7; Severe pain (n=63)
|
0 Participants
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain
Day 8; No pain (n=62)
|
13 Participants
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain
Day 8; Mild pain (n=62)
|
38 Participants
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain
Day 8; Moderate pain (n=62)
|
11 Participants
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain
Day 8; Severe pain (n=62)
|
0 Participants
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain
Day 9; No pain (n=62)
|
14 Participants
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain
Day 9; Mild pain (n=62)
|
40 Participants
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain
Day 9; Moderate pain (n=62)
|
7 Participants
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain
Day 9; Severe pain (n=62)
|
1 Participants
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain
Day 10 or ED; No pain (n=66)
|
15 Participants
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain
Day 10 or ED; Mild pain (n=66)
|
40 Participants
|
|
Number of Participants With Pain Intensity Assessed by Categorical Scale for Pain
Day 10 or ED; Moderate pain(n=66)
|
8 Participants
|
SECONDARY outcome
Timeframe: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 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
n=66 Participants
Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator's discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).
|
|---|---|
|
Number of Participants With Total Duration of Pain Per Day
Day 2; >= 4 to < 8 hours (n=65)
|
9 Participants
|
|
Number of Participants With Total Duration of Pain Per Day
Day 2; >= 8 to < 12 hours (n=65)
|
6 Participants
|
|
Number of Participants With Total Duration of Pain Per Day
Day 2; >= 12 hours (n=65)
|
1 Participants
|
|
Number of Participants With Total Duration of Pain Per Day
Day 3; >= 4 to < 8 hours (n=65)
|
6 Participants
|
|
Number of Participants With Total Duration of Pain Per Day
Day 3; >= 8 to < 12 hours (n=65)
|
9 Participants
|
|
Number of Participants With Total Duration of Pain Per Day
Day 5; >= 4 to < 8 hours (n=63)
|
10 Participants
|
|
Number of Participants With Total Duration of Pain Per Day
Day 5; >= 8 to < 12 hours (n=63)
|
2 Participants
|
|
Number of Participants With Total Duration of Pain Per Day
Day 5; >= 12 hours (n=63)
|
1 Participants
|
|
Number of Participants With Total Duration of Pain Per Day
Day 5; 24 hours (n=63)
|
5 Participants
|
|
Number of Participants With Total Duration of Pain Per Day
Day 6; < 4 hours (n=63)
|
46 Participants
|
|
Number of Participants With Total Duration of Pain Per Day
Day 6; >= 4 to < 8 hours (n=63)
|
6 Participants
|
|
Number of Participants With Total Duration of Pain Per Day
Day 6; 24 hours (n=63)
|
7 Participants
|
|
Number of Participants With Total Duration of Pain Per Day
Day 7; < 4 hours (n=63)
|
44 Participants
|
|
Number of Participants With Total Duration of Pain Per Day
Day 7; >= 8 to < 12 hours (n=63)
|
4 Participants
|
|
Number of Participants With Total Duration of Pain Per Day
Day 7; >= 12 hours (n=63)
|
1 Participants
|
|
Number of Participants With Total Duration of Pain Per Day
Day 8; >= 8 to < 12 hours (n=62)
|
4 Participants
|
|
Number of Participants With Total Duration of Pain Per Day
Day 8; >= 12 hours (n=62)
|
1 Participants
|
|
Number of Participants With Total Duration of Pain Per Day
Day 8; 24 hours (n=62)
|
7 Participants
|
|
Number of Participants With Total Duration of Pain Per Day
Day 9; >= 8 to < 12 hours (n=62)
|
3 Participants
|
|
Number of Participants With Total Duration of Pain Per Day
Day 9; >= 12 hours (n=62)
|
1 Participants
|
|
Number of Participants With Total Duration of Pain Per Day
Day 10 or ED; >=8 to <12 hours (n=66)
|
3 Participants
|
|
Number of Participants With Total Duration of Pain Per Day
Day 10 or ED; >= 12 hours (n=66)
|
2 Participants
|
|
Number of Participants With Total Duration of Pain Per Day
Day 10 or ED; 24 hours (n=66)
|
5 Participants
|
|
Number of Participants With Total Duration of Pain Per Day
Day 1; < 4 hours (n=66)
|
44 Participants
|
|
Number of Participants With Total Duration of Pain Per Day
Day 1; >= 4 to < 8 hours (n=66)
|
9 Participants
|
|
Number of Participants With Total Duration of Pain Per Day
Day 1; >= 8 to < 12 hours (n=66)
|
6 Participants
|
|
Number of Participants With Total Duration of Pain Per Day
Day 1; >= 12 hours (n=66)
|
0 Participants
|
|
Number of Participants With Total Duration of Pain Per Day
Day 1; 24 hours (n=66)
|
7 Participants
|
|
Number of Participants With Total Duration of Pain Per Day
Day 2; < 4 hours (n=65)
|
44 Participants
|
|
Number of Participants With Total Duration of Pain Per Day
Day 2; 24 hours (n=65)
|
5 Participants
|
|
Number of Participants With Total Duration of Pain Per Day
Day 3; < 4 hours (n=65)
|
41 Participants
|
|
Number of Participants With Total Duration of Pain Per Day
Day 3; >= 12 hours (n=65)
|
3 Participants
|
|
Number of Participants With Total Duration of Pain Per Day
Day 3; 24 hours (n=65)
|
6 Participants
|
|
Number of Participants With Total Duration of Pain Per Day
Day 4; < 4 hours (n=64)
|
47 Participants
|
|
Number of Participants With Total Duration of Pain Per Day
Day 4; >= 4 to < 8 hours (n=64)
|
8 Participants
|
|
Number of Participants With Total Duration of Pain Per Day
Day 4; >= 8 to < 12 hours (n=64)
|
2 Participants
|
|
Number of Participants With Total Duration of Pain Per Day
Day 4; >= 12 hours (n=64)
|
2 Participants
|
|
Number of Participants With Total Duration of Pain Per Day
Day 4; 24 hours (n=64)
|
5 Participants
|
|
Number of Participants With Total Duration of Pain Per Day
Day 5; < 4 hours (n=63)
|
45 Participants
|
|
Number of Participants With Total Duration of Pain Per Day
Day 6; >= 8 to < 12 hours (n=63)
|
3 Participants
|
|
Number of Participants With Total Duration of Pain Per Day
Day 6; >= 12 hours (n=63)
|
1 Participants
|
|
Number of Participants With Total Duration of Pain Per Day
Day 7; >= 4 to < 8 hours (n=63)
|
7 Participants
|
|
Number of Participants With Total Duration of Pain Per Day
Day 7; 24 hours (n=63)
|
7 Participants
|
|
Number of Participants With Total Duration of Pain Per Day
Day 8; < 4 hours (n=62)
|
44 Participants
|
|
Number of Participants With Total Duration of Pain Per Day
Day 8; >= 4 to < 8 hours (n=62)
|
6 Participants
|
|
Number of Participants With Total Duration of Pain Per Day
Day 9; < 4 hours (n=62)
|
47 Participants
|
|
Number of Participants With Total Duration of Pain Per Day
Day 9; >= 4 to < 8 hours (n=62)
|
6 Participants
|
|
Number of Participants With Total Duration of Pain Per Day
Day 9; 24 hours (n=62)
|
5 Participants
|
|
Number of Participants With Total Duration of Pain Per Day
Day 10 or ED; < 4 hours (n=66)
|
50 Participants
|
|
Number of Participants With Total Duration of Pain Per Day
Day 10 or ED; >=4 to < 8 hours (n=66)
|
6 Participants
|
SECONDARY outcome
Timeframe: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 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 the dose of a fast-acting opioid analgesic (except fentanyl preparations) given in case of breakthrough pain or lack of analgesic effect.
Outcome measures
| Measure |
Fentanyl
n=66 Participants
Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator's discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).
|
|---|---|
|
Mean Number of Rescue Doses
Day 3; (n=65)
|
0.7 Rescue Doses
Standard Deviation 1.14
|
|
Mean Number of Rescue Doses
Day 8; (n=62)
|
0.7 Rescue Doses
Standard Deviation 1.14
|
|
Mean Number of Rescue Doses
Day 9; (n=62)
|
0.8 Rescue Doses
Standard Deviation 1.33
|
|
Mean Number of Rescue Doses
Day 1; (n=66)
|
0.2 Rescue Doses
Standard Deviation 0.47
|
|
Mean Number of Rescue Doses
Day 2; (n=65)
|
0.8 Rescue Doses
Standard Deviation 1.06
|
|
Mean Number of Rescue Doses
Day 4; (n=64)
|
0.7 Rescue Doses
Standard Deviation 1.04
|
|
Mean Number of Rescue Doses
Day 5; (n=63)
|
0.7 Rescue Doses
Standard Deviation 1.05
|
|
Mean Number of Rescue Doses
Day 6; (n=63)
|
0.7 Rescue Doses
Standard Deviation 1.10
|
|
Mean Number of Rescue Doses
Day 7; (n=63)
|
0.8 Rescue Doses
Standard Deviation 1.42
|
|
Mean Number of Rescue Doses
Day 10 or ED; (n=66)
|
0.5 Rescue Doses
Standard Deviation 0.83
|
SECONDARY outcome
Timeframe: Day 10 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.
The treating physician assessed the therapeutic efficacy (effectiveness) of the study drug by 2-point scale of effective and ineffective. Number of participants with effective and ineffective therapeutic efficacy with respect to the study drug were reported.
Outcome measures
| Measure |
Fentanyl
n=66 Participants
Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator's discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).
|
|---|---|
|
Number of Participants With Response Based on Physician's Global Assessment Scale
Effective
|
63 Participants
|
|
Number of Participants With Response Based on Physician's Global Assessment Scale
Ineffective
|
3 Participants
|
Adverse Events
Fentanyl
Serious events: 6 serious events
Other events: 56 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fentanyl
n=66 participants at risk
Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator's discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).
|
|---|---|
|
Infections and infestations
Pneumonia
|
1.5%
1/66 • From signing of informed consent up to 7 days after the completion or discontinuation of last study treatment
|
|
Infections and infestations
Staphylococcal sepsis
|
1.5%
1/66 • From signing of informed consent up to 7 days after the completion or discontinuation of last study treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
1.5%
1/66 • From signing of informed consent up to 7 days after the completion or discontinuation of last study treatment
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.5%
1/66 • From signing of informed consent up to 7 days after the completion or discontinuation of last study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
1.5%
1/66 • From signing of informed consent up to 7 days after the completion or discontinuation of last study treatment
|
|
Gastrointestinal disorders
Ileus
|
1.5%
1/66 • From signing of informed consent up to 7 days after the completion or discontinuation of last study treatment
|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.5%
1/66 • From signing of informed consent up to 7 days after the completion or discontinuation of last study treatment
|
Other adverse events
| Measure |
Fentanyl
n=66 participants at risk
Fentanyl 1-day application transdermal patch (patch containing a drug that was put on the skin so the drug entered the body through the skin) releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction was as per Investigator's discretion (maximum applied dose was 300 mcg/hr) up to Day 7 and then dose was fixed for next 3 days that is Day 10 (end of treatment period).
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
6.1%
4/66 • From signing of informed consent up to 7 days after the completion or discontinuation of last study treatment
|
|
Psychiatric disorders
Insomnia
|
7.6%
5/66 • From signing of informed consent up to 7 days after the completion or discontinuation of last study treatment
|
|
Nervous system disorders
Dizziness
|
6.1%
4/66 • From signing of informed consent up to 7 days after the completion or discontinuation of last study treatment
|
|
Nervous system disorders
Somnolence
|
54.5%
36/66 • From signing of informed consent up to 7 days after the completion or discontinuation of last study treatment
|
|
Gastrointestinal disorders
Constipation
|
51.5%
34/66 • From signing of informed consent up to 7 days after the completion or discontinuation of last study treatment
|
|
Gastrointestinal disorders
Diarrhoea
|
24.2%
16/66 • From signing of informed consent up to 7 days after the completion or discontinuation of last study treatment
|
|
Gastrointestinal disorders
Nausea
|
37.9%
25/66 • From signing of informed consent up to 7 days after the completion or discontinuation of last study treatment
|
|
Gastrointestinal disorders
Vomiting
|
34.8%
23/66 • From signing of informed consent up to 7 days after the completion or discontinuation of last study treatment
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.1%
4/66 • From signing of informed consent up to 7 days after the completion or discontinuation of last study treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.1%
6/66 • From signing of informed consent up to 7 days after the completion or discontinuation of last study treatment
|
|
General disorders
Application site erythema
|
6.1%
4/66 • From signing of informed consent up to 7 days after the completion or discontinuation of last study treatment
|
|
General disorders
Application site pruritus
|
10.6%
7/66 • From signing of informed consent up to 7 days after the completion or discontinuation of last study treatment
|
|
General disorders
Pyrexia
|
6.1%
4/66 • From signing of informed consent up to 7 days after the completion or discontinuation of last study treatment
|
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