Trial Outcomes & Findings for A Study to Evaluate Efficacy and Safety of a Single Application of Capsaicin 8%Transdermal Delivery System Compared to Placebo in Reducing Pain Intensity in Subjects With Painful Diabetic Peripheral Neuropathy (PDPN) (NCT NCT01533428)
NCT ID: NCT01533428
Last Updated: 2015-11-04
Results Overview
Percent change in the average daily pain score from baseline to between Weeks 2 and 8, measured using Question 5 of the Brief Pain Inventory-Diabetic Neuropathy (BPI-DN). Participants assessed their pain due to diabetes in the last 24 hours on a numeric rating scale from 0 (no pain) to 10 (pain as bad as you can imagine).
COMPLETED
PHASE3
369 participants
Baseline to between Weeks 2 to 8
2015-11-04
Participant Flow
Participant milestones
| Measure |
Capsaicin 8%
Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
|
Placebo
Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
|
|---|---|---|
|
Overall Study
STARTED
|
186
|
183
|
|
Overall Study
COMPLETED
|
177
|
175
|
|
Overall Study
NOT COMPLETED
|
9
|
8
|
Reasons for withdrawal
| Measure |
Capsaicin 8%
Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
|
Placebo
Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
7
|
6
|
Baseline Characteristics
A Study to Evaluate Efficacy and Safety of a Single Application of Capsaicin 8%Transdermal Delivery System Compared to Placebo in Reducing Pain Intensity in Subjects With Painful Diabetic Peripheral Neuropathy (PDPN)
Baseline characteristics by cohort
| Measure |
Capsaicin 8%
n=186 Participants
Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
|
Placebo
n=183 Participants
Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
|
Total
n=369 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.90 years
STANDARD_DEVIATION 10.64 • n=5 Participants
|
62.00 years
STANDARD_DEVIATION 10.81 • n=7 Participants
|
63.00 years
STANDARD_DEVIATION 10.75 • n=5 Participants
|
|
Sex: Female, Male
Female
|
72 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
154 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
114 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
215 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
132 participants
n=5 Participants
|
131 participants
n=7 Participants
|
263 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
36 participants
n=5 Participants
|
38 participants
n=7 Participants
|
74 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
11 participants
n=5 Participants
|
7 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Duration of Painful Diabetic Peripheral Neuropathy (PDPN)
|
5.83 years
STANDARD_DEVIATION 4.01 • n=5 Participants
|
5.72 years
STANDARD_DEVIATION 3.98 • n=7 Participants
|
5.78 years
STANDARD_DEVIATION 3.99 • n=5 Participants
|
|
Glycosylated Hemoglobin (HbA1c)
|
7.39 Percentage of Glycosylated Hemoglobin
STANDARD_DEVIATION 1.309 • n=5 Participants
|
7.23 Percentage of Glycosylated Hemoglobin
STANDARD_DEVIATION 1.223 • n=7 Participants
|
7.31 Percentage of Glycosylated Hemoglobin
STANDARD_DEVIATION 1.268 • n=5 Participants
|
|
Average Pain Score
|
6.64 units on a scale
STANDARD_DEVIATION 1.416 • n=5 Participants
|
6.38 units on a scale
STANDARD_DEVIATION 1.473 • n=7 Participants
|
6.51 units on a scale
STANDARD_DEVIATION 1.449 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to between Weeks 2 to 8Population: Intention to Treat (ITT); Baseline Last Observation Carried Forward (BLOCF) imputation was used.
Percent change in the average daily pain score from baseline to between Weeks 2 and 8, measured using Question 5 of the Brief Pain Inventory-Diabetic Neuropathy (BPI-DN). Participants assessed their pain due to diabetes in the last 24 hours on a numeric rating scale from 0 (no pain) to 10 (pain as bad as you can imagine).
Outcome measures
| Measure |
Capsaicin 8%
n=186 Participants
Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
|
Placebo
n=183 Participants
Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
|
|---|---|---|
|
Percent Change in the Average Daily Pain Score From Baseline to Between Weeks 2 and 8
|
-27.44 percentage change
Standard Deviation 26.79
|
-20.85 percentage change
Standard Deviation 28.92
|
SECONDARY outcome
Timeframe: Baseline to between Weeks 2 and 12Population: Intention to Treat (ITT); Baseline Last Observation Carried Forward (BLOCF) imputation was used.
Percent Change in the Average Daily Pain Score from baseline to between Weeks 2 and 12 measured using Question 5 of the Brief Pain Inventory-Diabetic Neuropathy (BPI-DN). Participants assessed their pain due to diabetes in the last 24 hours on a numeric rating scale from 0 (no pain) to 10 (pain as bad as you can imagine).
Outcome measures
| Measure |
Capsaicin 8%
n=186 Participants
Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
|
Placebo
n=183 Participants
Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
|
|---|---|---|
|
Percent Change in the Average Daily Pain Score From Baseline to Between Weeks 2 and 12
|
-27.96 percentage change
Standard Deviation 27.25
|
-21.00 percentage change
Standard Deviation 29.42
|
SECONDARY outcome
Timeframe: Baseline to Weeks 2, 3, 4, 5, 6, 7, 8, 9,10, 11 and 12Population: Intention to Treat (ITT ); Baseline last observation carried forward (BLOCF) imputation was used.
Weekly Percent Change from baseline in average daily pain score from baseline to Week 12 measured using Question 5 of the Brief Pain Inventory-Diabetic Neuropathy (BPI-DN). Participants assessed their pain due to diabetes in the last 24 hours on a numeric rating scale from 0 (no pain) to 10 (pain as bad as you can imagine).
Outcome measures
| Measure |
Capsaicin 8%
n=186 Participants
Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
|
Placebo
n=183 Participants
Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
|
|---|---|---|
|
Weekly Percent Change From Baseline in Average Daily Pain Score
Week 2
|
-22.97 percentage change
Standard Deviation 26.24
|
-19.00 percentage change
Standard Deviation 27.99
|
|
Weekly Percent Change From Baseline in Average Daily Pain Score
Week 3
|
-27.17 percentage change
Standard Deviation 27.28
|
-20.51 percentage change
Standard Deviation 29.96
|
|
Weekly Percent Change From Baseline in Average Daily Pain Score
Week 4
|
-28.18 percentage change
Standard Deviation 28.15
|
-21.11 percentage change
Standard Deviation 30.52
|
|
Weekly Percent Change From Baseline in Average Daily Pain Score
Week 5
|
-28.35 percentage change
Standard Deviation 29.48
|
-21.17 percentage change
Standard Deviation 30.26
|
|
Weekly Percent Change From Baseline in Average Daily Pain Score
Week 6
|
-27.87 percentage change
Standard Deviation 30.02
|
-21.66 percentage change
Standard Deviation 31.45
|
|
Weekly Percent Change From Baseline in Average Daily Pain Score
Week 7
|
-29.03 percentage change
Standard Deviation 29.98
|
-21.02 percentage change
Standard Deviation 32.50
|
|
Weekly Percent Change From Baseline in Average Daily Pain Score
Week 8
|
-28.53 percentage change
Standard Deviation 31.92
|
-21.46 percentage change
Standard Deviation 31.29
|
|
Weekly Percent Change From Baseline in Average Daily Pain Score
Week 9
|
-28.61 percentage change
Standard Deviation 31.64
|
-21.78 percentage change
Standard Deviation 31.05
|
|
Weekly Percent Change From Baseline in Average Daily Pain Score
Week 10
|
-28.17 percentage change
Standard Deviation 30.79
|
-20.73 percentage change
Standard Deviation 32.39
|
|
Weekly Percent Change From Baseline in Average Daily Pain Score
Week 11
|
-29.04 percentage change
Standard Deviation 31.13
|
-21.75 percentage change
Standard Deviation 32.58
|
|
Weekly Percent Change From Baseline in Average Daily Pain Score
Week 12
|
-29.64 percentage change
Standard Deviation 31.20
|
-20.76 percentage change
Standard Deviation 33.33
|
SECONDARY outcome
Timeframe: Baseline and Weeks 2, 4, 8 and 12Population: Intention to Treat (ITT); Baseline Last Observation Carried Forward (BLOCF) imputation was used.
Weekly average of average daily pain score at Baseline and Weeks 2,4,8 and 12 measured using Question 5 of the Brief Pain Inventory-Diabetic Neuropathy (BPI-DN). Participants assessed their pain due to diabetes in the last 24 hours on a numeric rating scale from 0 (no pain) to 10 (pain as bad as you can imagine).
Outcome measures
| Measure |
Capsaicin 8%
n=186 Participants
Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
|
Placebo
n=183 Participants
Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
|
|---|---|---|
|
Weekly Average of Average Daily Pain at Baseline and Every Week After Baseline
Baseline
|
6.64 units on a scale
Standard Deviation 1.416
|
6.38 units on a scale
Standard Deviation 1.473
|
|
Weekly Average of Average Daily Pain at Baseline and Every Week After Baseline
Week 2
|
5.14 units on a scale
Standard Deviation 2.059
|
5.14 units on a scale
Standard Deviation 2.111
|
|
Weekly Average of Average Daily Pain at Baseline and Every Week After Baseline
Week 4
|
4.83 units on a scale
Standard Deviation 2.280
|
5.02 units on a scale
Standard Deviation 2.299
|
|
Weekly Average of Average Daily Pain at Baseline and Every Week After Baseline
Week 8
|
4.78 units on a scale
Standard Deviation 2.457
|
5.01 units on a scale
Standard Deviation 2.343
|
|
Weekly Average of Average Daily Pain at Baseline and Every Week After Baseline
Week 12
|
4.73 units on a scale
Standard Deviation 2.436
|
5.08 units on a scale
Standard Deviation 2.456
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2-8 and Weeks 2-12Population: Intention to Treat (ITT ); Baseline last observation carried forward(BLOCF) imputation was used.
Percentage of participants achieving 30% decrease in the average daily pain score in Weeks 2 and 8 and Weeks 2 and 12 measured using Question 5 of the Brief Pain Inventory-Diabetic Neuropathy (BPI-DN). Participants assessed their pain on a numeric rating scale from 0 (no pain) to 10 (pain as bad as you can imagine).
Outcome measures
| Measure |
Capsaicin 8%
n=186 Participants
Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
|
Placebo
n=183 Participants
Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
|
|---|---|---|
|
Percentage of Participants With 30% Reduction in Average Daily Pain Score.
30% Pain Reduction-Week 2 to 8
|
74 percentage of participants
|
60 percentage of participants
|
|
Percentage of Participants With 30% Reduction in Average Daily Pain Score.
30% Pain Reduction-Week 2 to 12
|
76 percentage of participants
|
58 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2-8 and Weeks 2-12Population: Intention to Treat (ITT ); Baseline last observation carried forward(BLOCF) imputation was used.
Percentage of participants achieving 50% decrease in the average daily pain score in Weeks 2 and 8 and Weeks 2 and 12 measured using Question 5 of the Brief Pain Inventory-Diabetic Neuropathy (BPI-DN). Participants assessed their pain on a numeric rating scale from 0 (no pain) to 10 (pain as bad as you can imagine).
Outcome measures
| Measure |
Capsaicin 8%
n=186 Participants
Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
|
Placebo
n=183 Participants
Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
|
|---|---|---|
|
Percentage of Participants With 50% Reduction in Average Daily Pain Score.
50% Pain Reduction-Week 2 to 8
|
39 percentage of participants
|
33 percentage of participants
|
|
Percentage of Participants With 50% Reduction in Average Daily Pain Score.
50% Pain Reduction-Week 2 to 12
|
41 percentage of participants
|
35 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 2Population: Intention to Treat (ITT); Baseline Last Observation Carried Forward (BLOCF) imputation was used.
Overall participant status assessed using Patient Global Impression of Change (PGIC) self-assessment questionnaire which was used by participants to report on 7 categories listed as follows; Very Much Improved, Much Improved, Minimally Improved, No Change, Minimally Worse, Much Worse and Very Much Worse in Week 2
Outcome measures
| Measure |
Capsaicin 8%
n=183 Participants
Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
|
Placebo
n=180 Participants
Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
|
|---|---|---|
|
Overall Participant Status Assessed Using Patient Global Impression of Change (PGIC) Self-assessment Questionnaire in Week 2
Very Much Improved
|
10 participants
|
9 participants
|
|
Overall Participant Status Assessed Using Patient Global Impression of Change (PGIC) Self-assessment Questionnaire in Week 2
Much Improved
|
49 participants
|
38 participants
|
|
Overall Participant Status Assessed Using Patient Global Impression of Change (PGIC) Self-assessment Questionnaire in Week 2
Minimally Improved
|
72 participants
|
58 participants
|
|
Overall Participant Status Assessed Using Patient Global Impression of Change (PGIC) Self-assessment Questionnaire in Week 2
No Change
|
45 participants
|
68 participants
|
|
Overall Participant Status Assessed Using Patient Global Impression of Change (PGIC) Self-assessment Questionnaire in Week 2
Minimally Worse
|
3 participants
|
6 participants
|
|
Overall Participant Status Assessed Using Patient Global Impression of Change (PGIC) Self-assessment Questionnaire in Week 2
Much Worse
|
3 participants
|
0 participants
|
|
Overall Participant Status Assessed Using Patient Global Impression of Change (PGIC) Self-assessment Questionnaire in Week 2
Very Much Worse
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline to Week 8Population: Intention to Treat (ITT); Baseline Last Observation Carried Forward (BLOCF) imputation was used.
Overall participant status assessed using Patient Global Impression of Change (PGIC) self-assessment questionnaire which was used by participants to report on 7 categories listed as follows; Very Much Improved, Much Improved, Minimally Improved, No Change, Minimally Worse, Much Worse and Very Much Worse in Week 8
Outcome measures
| Measure |
Capsaicin 8%
n=180 Participants
Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
|
Placebo
n=172 Participants
Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
|
|---|---|---|
|
Overall Participant Status Assessed Using Patient Global Impression of Change (PGIC) Self-assessment Questionnaire in Week 8
Very Much Improved
|
20 participants
|
16 participants
|
|
Overall Participant Status Assessed Using Patient Global Impression of Change (PGIC) Self-assessment Questionnaire in Week 8
Much Improved
|
51 participants
|
36 participants
|
|
Overall Participant Status Assessed Using Patient Global Impression of Change (PGIC) Self-assessment Questionnaire in Week 8
Minimally Improved
|
58 participants
|
48 participants
|
|
Overall Participant Status Assessed Using Patient Global Impression of Change (PGIC) Self-assessment Questionnaire in Week 8
No Change
|
47 participants
|
59 participants
|
|
Overall Participant Status Assessed Using Patient Global Impression of Change (PGIC) Self-assessment Questionnaire in Week 8
Minimally Worse
|
4 participants
|
8 participants
|
|
Overall Participant Status Assessed Using Patient Global Impression of Change (PGIC) Self-assessment Questionnaire in Week 8
Much Worse
|
0 participants
|
4 participants
|
|
Overall Participant Status Assessed Using Patient Global Impression of Change (PGIC) Self-assessment Questionnaire in Week 8
Very Much Worse
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Intention to Treat (ITT); Baseline Last Observation Carried Forward (BLOCF) imputation was used.
Overall participant status assessed using Patient Global Impression of Change (PGIC) self-assessment questionnaire which was used by participants to report on 7 categories listed as follows; Very Much Improved, Much Improved, Minimally Improved, No Change, Minimally Worse, Much Worse and Very Much Worse in Week 12
Outcome measures
| Measure |
Capsaicin 8%
n=168 Participants
Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
|
Placebo
n=172 Participants
Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
|
|---|---|---|
|
Overall Participant Status Assessed Using Patient Global Impression of Change (PGIC) Self-assessment Questionnaire in Week 12
Very Much Improved
|
23 participants
|
22 participants
|
|
Overall Participant Status Assessed Using Patient Global Impression of Change (PGIC) Self-assessment Questionnaire in Week 12
Much Improved
|
45 participants
|
29 participants
|
|
Overall Participant Status Assessed Using Patient Global Impression of Change (PGIC) Self-assessment Questionnaire in Week 12
Minimally Improved
|
39 participants
|
40 participants
|
|
Overall Participant Status Assessed Using Patient Global Impression of Change (PGIC) Self-assessment Questionnaire in Week 12
No Change
|
50 participants
|
72 participants
|
|
Overall Participant Status Assessed Using Patient Global Impression of Change (PGIC) Self-assessment Questionnaire in Week 12
Minimally Worse
|
9 participants
|
8 participants
|
|
Overall Participant Status Assessed Using Patient Global Impression of Change (PGIC) Self-assessment Questionnaire in Week 12
Much Worse
|
2 participants
|
1 participants
|
|
Overall Participant Status Assessed Using Patient Global Impression of Change (PGIC) Self-assessment Questionnaire in Week 12
Very Much Worse
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline to Weeks 2, 8 and 12Population: Intention to Treat (ITT); Baseline and Last Observation Carried Forward (BLOCF) imputation was used.
Change from Baseline in the European Quality Of Life (QOL) questionnaire in 5 dimensions (EQ-5D) with Visual Analog Scale (VAS) to Weeks 2, 8 and 12. EQ-5D self-reported questionnaire is used to measure health-related quality of life by measuring 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D questionnaire includes a visual analog scale (VAS) which records participants self-rated health status on a graduated (0-100) scale with higher scores indicating higher Health-Related Quality of Life (HRQoL).
Outcome measures
| Measure |
Capsaicin 8%
n=186 Participants
Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
|
Placebo
n=183 Participants
Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
|
|---|---|---|
|
Change From Baseline in the European Quality Of Life (QOL) Questionnaire in 5 Dimensions (EQ-5D) With Visual Analog Scale (VAS) to Weeks 2, 8 and 12
Week 8 [ N=180;N=170]
|
4.0 units on a scale
Standard Deviation 17.09
|
3.5 units on a scale
Standard Deviation 18.36
|
|
Change From Baseline in the European Quality Of Life (QOL) Questionnaire in 5 Dimensions (EQ-5D) With Visual Analog Scale (VAS) to Weeks 2, 8 and 12
Week 12 [N=170; N=172]
|
3.8 units on a scale
Standard Deviation 17.94
|
3.7 units on a scale
Standard Deviation 19.08
|
|
Change From Baseline in the European Quality Of Life (QOL) Questionnaire in 5 Dimensions (EQ-5D) With Visual Analog Scale (VAS) to Weeks 2, 8 and 12
Week 2 [N=184; N=181]
|
1.3 units on a scale
Standard Deviation 15.20
|
3.9 units on a scale
Standard Deviation 18.81
|
SECONDARY outcome
Timeframe: Baseline to Weeks 2, 8 and 12Population: Intention to Treat (ITT); Baseline and Last Observation Carried Forward (BLOCF) imputation was used.
The Hospital Anxiety and Depression Scale (HADS) is a self-report scale developed for the assessment of anxiety and depression, that contain 14 items rated on a 4-point Likert-type scale. There are 2 subscales,one assessing depression and the other anxiety. The 7-item depression and anxiety subscales yield scores of 0 to 21 that are interpreted with the following cut-off points: 0 to 7, normal; 8 to 10, mild mood disturbance; 11 to 14, moderate mood disturbance; and 15 to 21, severe mood disturbance.
Outcome measures
| Measure |
Capsaicin 8%
n=186 Participants
Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
|
Placebo
n=183 Participants
Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
|
|---|---|---|
|
Change in Hospital Anxiety and Depression Scale (HADS) Anxiety Scale From Baseline to Weeks 2, 8 and 12
Week 2 [N=183; N=180]
|
-0.4 units on a scale
Standard Deviation 2.57
|
-0.5 units on a scale
Standard Deviation 2.74
|
|
Change in Hospital Anxiety and Depression Scale (HADS) Anxiety Scale From Baseline to Weeks 2, 8 and 12
Week 8 [N=178; N=171]
|
-0.7 units on a scale
Standard Deviation 2.72
|
-0.6 units on a scale
Standard Deviation 3.11
|
|
Change in Hospital Anxiety and Depression Scale (HADS) Anxiety Scale From Baseline to Weeks 2, 8 and 12
Week 12 [N=169; N=169]
|
-0.9 units on a scale
Standard Deviation 2.90
|
-0.9 units on a scale
Standard Deviation 3.03
|
SECONDARY outcome
Timeframe: Baseline to Weeks 2, 8 and 12Population: Intention to Treat (ITT); Baseline and Last Observation Carried Forward (BLOCF) imputation was used.
The Hospital Anxiety and Depression Scale (HADS) is a self-report scale developed for the assessment of anxiety and depression, it contains 14 items rated on a 4-point Likert-type scale. There are 2 subscales,one assessing depression and the other anxiety. The 7-item depression and anxiety subscales yield scores of 0 to 21 that are interpreted with the following cut-off points: 0 to 7, normal; 8 to 10, mild mood disturbance; 11 to 14, moderate mood disturbance; and 15 to 21, severe mood disturbance.
Outcome measures
| Measure |
Capsaicin 8%
n=186 Participants
Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
|
Placebo
n=183 Participants
Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
|
|---|---|---|
|
Change in Hospital Anxiety and Depression Scale (HADS) Depression Scale From Baseline to Weeks 2, 8 and 12.
Week 2 [ N=184; N=181]
|
-0.6 units on a scale
Standard Deviation 2.39
|
-0.6 units on a scale
Standard Deviation 2.73
|
|
Change in Hospital Anxiety and Depression Scale (HADS) Depression Scale From Baseline to Weeks 2, 8 and 12.
Week 8 [N=180; N=171]
|
-0.7 units on a scale
Standard Deviation 2.42
|
-0.4 units on a scale
Standard Deviation 3.15
|
|
Change in Hospital Anxiety and Depression Scale (HADS) Depression Scale From Baseline to Weeks 2, 8 and 12.
Week 12 [N=169; N=171]
|
-0.8 units on a scale
Standard Deviation 2.41
|
-0.6 units on a scale
Standard Deviation 3.24
|
SECONDARY outcome
Timeframe: Baseline, Weeks 8 and 12Population: Intention to Treat (ITT); Baseline Last Observation Carried Forward (BLOCF) imputation was used.
Treatment satisfaction assessment based on Self-Assessment Treatment (SAT II) questionnaire and the question "Over the past 7 days, how much has the study treatment improved your pain level?"
Outcome measures
| Measure |
Capsaicin 8%
n=186 Participants
Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
|
Placebo
n=183 Participants
Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
|
|---|---|---|
|
Treatment Satisfaction Assessment Based on Self-Assessment of Treatment (SAT II) Questionnaire at Baseline, Weeks 8 and 12
Week 8 [N=177; N=170] [Not at all]
|
59 participants
|
82 participants
|
|
Treatment Satisfaction Assessment Based on Self-Assessment of Treatment (SAT II) Questionnaire at Baseline, Weeks 8 and 12
Week 8 [N=177; N=170] [Slightly Better]
|
35 participants
|
33 participants
|
|
Treatment Satisfaction Assessment Based on Self-Assessment of Treatment (SAT II) Questionnaire at Baseline, Weeks 8 and 12
Week 8 [N=177; N=170] [Moderately Better]
|
37 participants
|
21 participants
|
|
Treatment Satisfaction Assessment Based on Self-Assessment of Treatment (SAT II) Questionnaire at Baseline, Weeks 8 and 12
Week 8 [N=177; N=170] [Quite a Bit Better]
|
30 participants
|
21 participants
|
|
Treatment Satisfaction Assessment Based on Self-Assessment of Treatment (SAT II) Questionnaire at Baseline, Weeks 8 and 12
Week 8 [N=177; N=170] [Very Much Better]
|
16 participants
|
13 participants
|
|
Treatment Satisfaction Assessment Based on Self-Assessment of Treatment (SAT II) Questionnaire at Baseline, Weeks 8 and 12
Week 12 [N=166; N=171] [Not at all]
|
69 participants
|
91 participants
|
|
Treatment Satisfaction Assessment Based on Self-Assessment of Treatment (SAT II) Questionnaire at Baseline, Weeks 8 and 12
Week 12 [N=166; N=171] [Slightly Better]
|
30 participants
|
38 participants
|
|
Treatment Satisfaction Assessment Based on Self-Assessment of Treatment (SAT II) Questionnaire at Baseline, Weeks 8 and 12
Week 12 [N=166; N=171] [Moderately Better]
|
23 participants
|
12 participants
|
|
Treatment Satisfaction Assessment Based on Self-Assessment of Treatment (SAT II) Questionnaire at Baseline, Weeks 8 and 12
Week 12 [N=166; N=171] [Quite a Bit Better]
|
29 participants
|
14 participants
|
|
Treatment Satisfaction Assessment Based on Self-Assessment of Treatment (SAT II) Questionnaire at Baseline, Weeks 8 and 12
Week 12 [N=166; N=171][Very Much Better]
|
15 participants
|
16 participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2-8 and Weeks 2-12Population: Intention to Treat (ITT); Baseline Last Observation Carried Forward (BLOCF) imputation was used.
Percent change in average sleep interference was measured by Question 9F of the Brief Pain Inventory-Diabetic Neuropathy (BPI DN) and was used to assess pain and sleep interference index. Daily sleep interference rating scale consists of an 11-point numerical scale with which the patient describes how pain related to diabetes has interfered with their sleep during the past 24 hours. On a scale 0 identifies "pain does not interfere with sleep" and 10 identifies "pain completely interferes with sleep". Average sleep interference score is assessed from baseline to Weeks 2-8 and Weeks 2-12.
Outcome measures
| Measure |
Capsaicin 8%
n=186 Participants
Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
|
Placebo
n=183 Participants
Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
|
|---|---|---|
|
Percent Change in Average Sleep Interference Score From Baseline to Between Weeks 2-8 and Weeks 2-12
Week 2-8
|
-33.12 percentage of change
Standard Deviation 33.683
|
-24.15 percentage of change
Standard Deviation 45.019
|
|
Percent Change in Average Sleep Interference Score From Baseline to Between Weeks 2-8 and Weeks 2-12
Week 2-12
|
-33.99 percentage of change
Standard Deviation 33.566
|
-24.67 percentage of change
Standard Deviation 43.188
|
SECONDARY outcome
Timeframe: Day 1, 15 minutes and 60 minutes after patch removalPopulation: Safety Analysis Set (SAF)
Tolerability of patch application was assessed by dermal assessment (0 to 7 point severity score on Dermal Assessment Scale). Data reported is based on the number of participants in the combined category with a score ≥ 4 (Definite edema or higher), 15 and 60 minutes after patch removal.
Outcome measures
| Measure |
Capsaicin 8%
n=186 Participants
Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
|
Placebo
n=183 Participants
Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
|
|---|---|---|
|
Tolerability of Patch Application Assessed by Dermal Assessment on Day 1, 15 Minutes and 60 Minutes After Patch Removal.
15 minutes after patch removal [N=185,N=180]
|
0 participants
|
2 participants
|
|
Tolerability of Patch Application Assessed by Dermal Assessment on Day 1, 15 Minutes and 60 Minutes After Patch Removal.
60 minutes after patch removal [N=185,N=179]
|
0 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Pre-application and 15 minutes and 60 minutes after patch removalPopulation: Safety Analysis Set (SAF)
Change from pre-application in"Pain Now" score was measured on a scale from 0-10 where 0 equates to "No Pain" and 10 to "Pain as bad as you can imagine". Participants were asked to provide pain ratings relative only to the area of pain undergoing treatment.
Outcome measures
| Measure |
Capsaicin 8%
n=186 Participants
Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
|
Placebo
n=183 Participants
Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
|
|---|---|---|
|
Change From Pre-application in"Pain Now" Score
15 minutes after patch removal [N=185; N=183]
|
-1.6 units on a scale
Standard Deviation 2.49
|
-2.0 units on a scale
Standard Deviation 2.08
|
|
Change From Pre-application in"Pain Now" Score
60 minutes after patch removal [N=185; N=182]
|
-1.8 units on a scale
Standard Deviation 2.57
|
-2.2 units on a scale
Standard Deviation 2.07
|
SECONDARY outcome
Timeframe: Days 1 - 5Population: Safety Analysis Set (SAF)
Summarized number of participants who used Rescue Pain Medications for Pain
Outcome measures
| Measure |
Capsaicin 8%
n=186 Participants
Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
|
Placebo
n=183 Participants
Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
|
|---|---|---|
|
Number of Participants Who Used Rescue Pain Medication Days 1 Through 5
Overall
|
35 participants
|
10 participants
|
|
Number of Participants Who Used Rescue Pain Medication Days 1 Through 5
Analgesics
|
22 participants
|
9 participants
|
|
Number of Participants Who Used Rescue Pain Medication Days 1 Through 5
Anilides
|
20 participants
|
9 participants
|
|
Number of Participants Who Used Rescue Pain Medication Days 1 Through 5
Natural opium alkaloids
|
14 participants
|
4 participants
|
|
Number of Participants Who Used Rescue Pain Medication Days 1 Through 5
Other opioids
|
2 participants
|
0 participants
|
|
Number of Participants Who Used Rescue Pain Medication Days 1 Through 5
Salicylic acid and derivatives
|
1 participants
|
0 participants
|
|
Number of Participants Who Used Rescue Pain Medication Days 1 Through 5
Antiinflammatory and antirheumatic products
|
15 participants
|
1 participants
|
|
Number of Participants Who Used Rescue Pain Medication Days 1 Through 5
Propionic acid derivatives
|
15 participants
|
1 participants
|
|
Number of Participants Who Used Rescue Pain Medication Days 1 Through 5
Other gynecologicals
|
15 participants
|
1 participants
|
|
Number of Participants Who Used Rescue Pain Medication Days 1 Through 5
Antiinflammatory products vaginal administration
|
15 participants
|
1 participants
|
|
Number of Participants Who Used Rescue Pain Medication Days 1 Through 5
Topical products for joint and muscular pain
|
16 participants
|
1 participants
|
|
Number of Participants Who Used Rescue Pain Medication Days 1 Through 5
Antiinflammatory preparations, nonsteroids for top
|
15 participants
|
1 participants
|
|
Number of Participants Who Used Rescue Pain Medication Days 1 Through 5
Preparations with salicylic acid derivatives
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Safety Analysis Set (SAF)
Number of patients assessed for Safety through Adverse Events (AE) and Serious Adverse Events (SAE), vital signs, and laboratory analyses from baseline to week 12
Outcome measures
| Measure |
Capsaicin 8%
n=186 Participants
Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
|
Placebo
n=183 Participants
Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
|
|---|---|---|
|
Safety Assessed Through Adverse Events (AE) and Serious Adverse Events (SAE), Vital Signs, and Laboratory Analyses From Baseline to Week 12
Treatment-emergent adverse events (TEAEs)
|
87 participants
|
62 participants
|
|
Safety Assessed Through Adverse Events (AE) and Serious Adverse Events (SAE), Vital Signs, and Laboratory Analyses From Baseline to Week 12
Drug-related TEAEs
|
65 participants
|
23 participants
|
|
Safety Assessed Through Adverse Events (AE) and Serious Adverse Events (SAE), Vital Signs, and Laboratory Analyses From Baseline to Week 12
Deaths
|
0 participants
|
0 participants
|
|
Safety Assessed Through Adverse Events (AE) and Serious Adverse Events (SAE), Vital Signs, and Laboratory Analyses From Baseline to Week 12
Serious TEAEs
|
2 participants
|
7 participants
|
|
Safety Assessed Through Adverse Events (AE) and Serious Adverse Events (SAE), Vital Signs, and Laboratory Analyses From Baseline to Week 12
Drug-related serious TEAEs
|
0 participants
|
0 participants
|
|
Safety Assessed Through Adverse Events (AE) and Serious Adverse Events (SAE), Vital Signs, and Laboratory Analyses From Baseline to Week 12
TEAEs permanent discontinuation of study drug
|
0 participants
|
0 participants
|
|
Safety Assessed Through Adverse Events (AE) and Serious Adverse Events (SAE), Vital Signs, and Laboratory Analyses From Baseline to Week 12
Drug-related TEAEs to permanent discontinuation
|
0 participants
|
0 participants
|
|
Safety Assessed Through Adverse Events (AE) and Serious Adverse Events (SAE), Vital Signs, and Laboratory Analyses From Baseline to Week 12
Application site reactions
|
63 participants
|
15 participants
|
Adverse Events
Capsaicin 8%
Placebo
Serious adverse events
| Measure |
Capsaicin 8%
n=186 participants at risk
Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
|
Placebo
n=183 participants at risk
Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/186 • Adverse Events were reported from the first application of study drug to Week 12 weeks
|
1.1%
2/183 • Adverse Events were reported from the first application of study drug to Week 12 weeks
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/186 • Adverse Events were reported from the first application of study drug to Week 12 weeks
|
0.55%
1/183 • Adverse Events were reported from the first application of study drug to Week 12 weeks
|
|
General disorders
Noncardiac chest pain
|
0.00%
0/186 • Adverse Events were reported from the first application of study drug to Week 12 weeks
|
0.55%
1/183 • Adverse Events were reported from the first application of study drug to Week 12 weeks
|
|
Infections and infestations
Postprocedural infection
|
0.00%
0/186 • Adverse Events were reported from the first application of study drug to Week 12 weeks
|
0.55%
1/183 • Adverse Events were reported from the first application of study drug to Week 12 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
0.54%
1/186 • Adverse Events were reported from the first application of study drug to Week 12 weeks
|
0.00%
0/183 • Adverse Events were reported from the first application of study drug to Week 12 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/186 • Adverse Events were reported from the first application of study drug to Week 12 weeks
|
0.55%
1/183 • Adverse Events were reported from the first application of study drug to Week 12 weeks
|
|
Nervous system disorders
Convulsion
|
0.54%
1/186 • Adverse Events were reported from the first application of study drug to Week 12 weeks
|
0.00%
0/183 • Adverse Events were reported from the first application of study drug to Week 12 weeks
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.00%
0/186 • Adverse Events were reported from the first application of study drug to Week 12 weeks
|
0.55%
1/183 • Adverse Events were reported from the first application of study drug to Week 12 weeks
|
|
Vascular disorders
Hypotension
|
0.00%
0/186 • Adverse Events were reported from the first application of study drug to Week 12 weeks
|
0.55%
1/183 • Adverse Events were reported from the first application of study drug to Week 12 weeks
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/186 • Adverse Events were reported from the first application of study drug to Week 12 weeks
|
0.55%
1/183 • Adverse Events were reported from the first application of study drug to Week 12 weeks
|
Other adverse events
| Measure |
Capsaicin 8%
n=186 participants at risk
Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
|
Placebo
n=183 participants at risk
Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
|
|---|---|---|
|
General disorders
Application site pain
|
9.7%
18/186 • Adverse Events were reported from the first application of study drug to Week 12 weeks
|
2.2%
4/183 • Adverse Events were reported from the first application of study drug to Week 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.8%
20/186 • Adverse Events were reported from the first application of study drug to Week 12 weeks
|
5.5%
10/183 • Adverse Events were reported from the first application of study drug to Week 12 weeks
|
|
Nervous system disorders
Burning sensation
|
14.0%
26/186 • Adverse Events were reported from the first application of study drug to Week 12 weeks
|
2.7%
5/183 • Adverse Events were reported from the first application of study drug to Week 12 weeks
|
Additional Information
Medical Science Director, Global Medical Science
Astellas Pharma Global Development
Results disclosure agreements
- Principal investigator is a sponsor employee Institute and/or Principal Investigator may publish or present trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript at least 30 days prior to publication to ensure that no confidential information of Sponsor is included in the document. Sponsor may delay the publication for an additional 60 days to seek patent protection.
- Publication restrictions are in place
Restriction type: OTHER