Trial Outcomes & Findings for Efficacy and Safety of Esflurbiprofen Hydrogel Patch in the Treatment of Local Acute Pain (NCT NCT04908748)
NCT ID: NCT04908748
Last Updated: 2023-09-28
Results Overview
Visual Analogue Scale (VAS) 0 = "no pain", 100 = "Extreme pain"
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
200 participants
Primary outcome timeframe
Change from baseline to Visit 5 (72 hours after initiating treatment)
Results posted on
2023-09-28
Participant Flow
Participant milestones
| Measure |
Active Arm
Esflurbiprofen Hydrogel Patch containing 165 mg Esflurbiprofen
|
Control Drug
Placebo patch that does not contain the active ingredient but is otherwise indistinguishable from the investigational drug Esflurbiprofen Hydrogel Patch
|
|---|---|---|
|
Overall Study
STARTED
|
98
|
102
|
|
Overall Study
COMPLETED
|
98
|
102
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of Esflurbiprofen Hydrogel Patch in the Treatment of Local Acute Pain
Baseline characteristics by cohort
| Measure |
Active Arm
n=98 Participants
Esflurbiprofen Hydrogel Patch containing 165 mg Esflurbiprofen
|
Control Drug
n=102 Participants
Placebo patch that does not contain the active ingredient but is otherwise indistinguishable from the investigational drug Esflurbiprofen Hydrogel Patch
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.2 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
34.3 years
STANDARD_DEVIATION 10.8 • n=7 Participants
|
33.7 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
60 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
37 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
98 participants
n=5 Participants
|
102 participants
n=7 Participants
|
200 participants
n=5 Participants
|
|
Type of injury
Contusions
|
73 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
145 Participants
n=5 Participants
|
|
Type of injury
Sprains＆Strains
|
25 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change from baseline to Visit 5 (72 hours after initiating treatment)Population: The Full Analysis Set (all randomized patients who received at least one dose of study drug).
Visual Analogue Scale (VAS) 0 = "no pain", 100 = "Extreme pain"
Outcome measures
| Measure |
Active Arm
n=98 Participants
Esflurbiprofen Hydrogel Patch containing 165 mg Esflurbiprofen
|
Control Drug
n=102 Participants
Placebo patch that does not contain the active ingredient but is otherwise indistinguishable from the investigational drug Esflurbiprofen Hydrogel Patch
|
|---|---|---|
|
Change of Pain-on-movement (POM) Compared to Baseline
|
-50.7 units on a scale
Standard Deviation 11.1
|
-21.6 units on a scale
Standard Deviation 11.9
|
SECONDARY outcome
Timeframe: Baseline and 12, 24, 48, 72, 96, 168 hours after initiating treatmentPopulation: The Full Analysis Set (all randomized patients who received at least one dose of study drug).
Visual Analogue Scale (VAS) 0 = "no pain", 100 = "Extreme pain"
Outcome measures
| Measure |
Active Arm
n=98 Participants
Esflurbiprofen Hydrogel Patch containing 165 mg Esflurbiprofen
|
Control Drug
n=102 Participants
Placebo patch that does not contain the active ingredient but is otherwise indistinguishable from the investigational drug Esflurbiprofen Hydrogel Patch
|
|---|---|---|
|
Pain-on-movement (POM) on VAS
Baseline
|
69.9 units on a scale
Standard Deviation 7.6
|
70.1 units on a scale
Standard Deviation 8.3
|
|
Pain-on-movement (POM) on VAS
12 hour
|
61.1 units on a scale
Standard Deviation 10.3
|
66.4 units on a scale
Standard Deviation 8.4
|
|
Pain-on-movement (POM) on VAS
24 hour
|
48.8 units on a scale
Standard Deviation 12.2
|
62.8 units on a scale
Standard Deviation 10.4
|
|
Pain-on-movement (POM) on VAS
48 hour
|
33.3 units on a scale
Standard Deviation 11.9
|
56.6 units on a scale
Standard Deviation 12.0
|
|
Pain-on-movement (POM) on VAS
72 hour
|
19.2 units on a scale
Standard Deviation 9.7
|
48.5 units on a scale
Standard Deviation 14.9
|
|
Pain-on-movement (POM) on VAS
96 hour
|
9.2 units on a scale
Standard Deviation 8.3
|
37.3 units on a scale
Standard Deviation 16.7
|
|
Pain-on-movement (POM) on VAS
168 hour
|
2.1 units on a scale
Standard Deviation 4.4
|
19.4 units on a scale
Standard Deviation 17.4
|
SECONDARY outcome
Timeframe: Baseline and 12, 24, 48, 72, 96, 168 hours after initiating treatmentPopulation: The Full Analysis Set (all randomized patients who received at least one dose of study drug).
Area-under-the-curve (AUC) over time during first 12, 24, 48, 72, 96 and 168 hours for Pain on movement (POM) measured using a VAS Visual Analogue Scale (VAS) 0 = "no pain", 100 = "Extreme pain"
Outcome measures
| Measure |
Active Arm
n=98 Participants
Esflurbiprofen Hydrogel Patch containing 165 mg Esflurbiprofen
|
Control Drug
n=102 Participants
Placebo patch that does not contain the active ingredient but is otherwise indistinguishable from the investigational drug Esflurbiprofen Hydrogel Patch
|
|---|---|---|
|
Area-under-the-curve for POM on VAS
0-12 h
|
814.9 AUC of POM VAS pain (mm* h)
Standard Deviation 107.0
|
842.9 AUC of POM VAS pain (mm* h)
Standard Deviation 109.3
|
|
Area-under-the-curve for POM on VAS
0-24 h
|
1424.5 AUC of POM VAS pain (mm* h)
Standard Deviation 210.3
|
1556.3 AUC of POM VAS pain (mm* h)
Standard Deviation 182.6
|
|
Area-under-the-curve for POM on VAS
0-48 h
|
2397.3 AUC of POM VAS pain (mm* h)
Standard Deviation 448.7
|
2970.3 AUC of POM VAS pain (mm* h)
Standard Deviation 415.3
|
|
Area-under-the-curve for POM on VAS
0-72 h
|
3026.1 AUC of POM VAS pain (mm* h)
Standard Deviation 655.8
|
4242.4 AUC of POM VAS pain (mm* h)
Standard Deviation 730.3
|
|
Area-under-the-curve for POM on VAS
0-96 h
|
3367.6 AUC of POM VAS pain (mm* h)
Standard Deviation 818.9
|
5300.7 AUC of POM VAS pain (mm* h)
Standard Deviation 1166.8
|
|
Area-under-the-curve for POM on VAS
0-168 h
|
3771.4 AUC of POM VAS pain (mm* h)
Standard Deviation 1149.6
|
7285.7 AUC of POM VAS pain (mm* h)
Standard Deviation 1952.1
|
SECONDARY outcome
Timeframe: Baseline and 12, 24, 48, 72, 96, 168 hours after initiating treatmentPopulation: The Full Analysis Set (all randomized patients who received at least one dose of study drug).
Visual Analogue Scale (VAS) 0 = "no pain", 100 = "Extreme pain"
Outcome measures
| Measure |
Active Arm
n=98 Participants
Esflurbiprofen Hydrogel Patch containing 165 mg Esflurbiprofen
|
Control Drug
n=102 Participants
Placebo patch that does not contain the active ingredient but is otherwise indistinguishable from the investigational drug Esflurbiprofen Hydrogel Patch
|
|---|---|---|
|
Pain-at-rest on VAS
Baseline
|
17.9 units on a scale
Standard Deviation 5.9
|
17.0 units on a scale
Standard Deviation 7.7
|
|
Pain-at-rest on VAS
12 h
|
14.7 units on a scale
Standard Deviation 6.1
|
15.2 units on a scale
Standard Deviation 6.4
|
|
Pain-at-rest on VAS
24 h
|
11.2 units on a scale
Standard Deviation 5.4
|
13.5 units on a scale
Standard Deviation 6.2
|
|
Pain-at-rest on VAS
48 h
|
7.5 units on a scale
Standard Deviation 4.6
|
11.5 units on a scale
Standard Deviation 6.2
|
|
Pain-at-rest on VAS
72 h
|
4.1 units on a scale
Standard Deviation 3.4
|
9.2 units on a scale
Standard Deviation 5.5
|
|
Pain-at-rest on VAS
96 h
|
2.0 units on a scale
Standard Deviation 2.7
|
6.5 units on a scale
Standard Deviation 5.4
|
|
Pain-at-rest on VAS
168 h
|
0.5 units on a scale
Standard Deviation 1.5
|
3.7 units on a scale
Standard Deviation 4.4
|
SECONDARY outcome
Timeframe: Baseline and 12, 24, 48, 72, 96, 168 (192) hours after initiating treatmentPopulation: The Full Analysis Set (all randomized patients who received at least one dose of study drug).
The time taken to achieve a meaningful (30 %) and optimal (50 %) reduction of pain measured on the VAS for POM Visual Analogue Scale (VAS) 0 = "no pain", 100 = "Extreme pain"
Outcome measures
| Measure |
Active Arm
n=98 Participants
Esflurbiprofen Hydrogel Patch containing 165 mg Esflurbiprofen
|
Control Drug
n=102 Participants
Placebo patch that does not contain the active ingredient but is otherwise indistinguishable from the investigational drug Esflurbiprofen Hydrogel Patch
|
|---|---|---|
|
Time to Meaningful and Optimal Reduction
Time to meaningful reduction of pain (h) (30% or more) · < 12
|
8 Participants
|
1 Participants
|
|
Time to Meaningful and Optimal Reduction
Time to meaningful reduction of pain (h) (30% or more) · 12-24
|
41 Participants
|
3 Participants
|
|
Time to Meaningful and Optimal Reduction
Time to meaningful reduction of pain (h) (30% or more) · 24-48
|
42 Participants
|
10 Participants
|
|
Time to Meaningful and Optimal Reduction
Time to meaningful reduction of pain (h) (30% or more) · 48-72
|
7 Participants
|
33 Participants
|
|
Time to Meaningful and Optimal Reduction
Time to meaningful reduction of pain (h) (30% or more) · 72-96
|
0 Participants
|
35 Participants
|
|
Time to Meaningful and Optimal Reduction
Time to meaningful reduction of pain (h) (30% or more) · 96-192
|
0 Participants
|
15 Participants
|
|
Time to Meaningful and Optimal Reduction
Time to meaningful reduction of pain (h) (30% or more) · Not achieved
|
0 Participants
|
5 Participants
|
|
Time to Meaningful and Optimal Reduction
Time to optimal reduction of pain (h) (50 % or more) · < 12
|
2 Participants
|
0 Participants
|
|
Time to Meaningful and Optimal Reduction
Time to optimal reduction of pain (h) (50 % or more) · 12-24
|
4 Participants
|
1 Participants
|
|
Time to Meaningful and Optimal Reduction
Time to optimal reduction of pain (h) (50 % or more) · 24-48
|
51 Participants
|
1 Participants
|
|
Time to Meaningful and Optimal Reduction
Time to optimal reduction of pain (h) (50 % or more) · 48-72
|
36 Participants
|
13 Participants
|
|
Time to Meaningful and Optimal Reduction
Time to optimal reduction of pain (h) (50 % or more) · 72-96
|
5 Participants
|
26 Participants
|
|
Time to Meaningful and Optimal Reduction
Time to optimal reduction of pain (h) (50 % or more) · 96-192
|
0 Participants
|
42 Participants
|
|
Time to Meaningful and Optimal Reduction
Time to optimal reduction of pain (h) (50 % or more) · Not achieved
|
0 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: Baseline and 12, 24, 48, 72, 96, 168 (192) hours after initiating treatmentPopulation: The Full Analysis Set (all randomized patients who received at least one dose of study drug).
Time to complete resolution of pain, i. e. reaching a POM VAS value of 0 mm after start of study treatment Visual Analogue Scale (VAS) 0 = "no pain", 100 = "Extreme pain"
Outcome measures
| Measure |
Active Arm
n=98 Participants
Esflurbiprofen Hydrogel Patch containing 165 mg Esflurbiprofen
|
Control Drug
n=102 Participants
Placebo patch that does not contain the active ingredient but is otherwise indistinguishable from the investigational drug Esflurbiprofen Hydrogel Patch
|
|---|---|---|
|
Time to Complete Resolution of Pain
48-72h
|
2 Participants
|
0 Participants
|
|
Time to Complete Resolution of Pain
72-96h
|
10 Participants
|
0 Participants
|
|
Time to Complete Resolution of Pain
96-192h
|
45 Participants
|
10 Participants
|
|
Time to Complete Resolution of Pain
Not achieved
|
41 Participants
|
92 Participants
|
SECONDARY outcome
Timeframe: 72 hoursPopulation: The Full Analysis Set (all randomized patients who received at least one dose of study drug).
defined as the percentage of patients achieving ≥50% reduction from baseline in the VAS score for POM at 72 hours Visual Analogue Scale (VAS) 0 = "no pain", 100 = "Extreme pain"
Outcome measures
| Measure |
Active Arm
n=98 Participants
Esflurbiprofen Hydrogel Patch containing 165 mg Esflurbiprofen
|
Control Drug
n=102 Participants
Placebo patch that does not contain the active ingredient but is otherwise indistinguishable from the investigational drug Esflurbiprofen Hydrogel Patch
|
|---|---|---|
|
Responder Rate 1
|
93 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: 48 h, 72 h, and 168 hPopulation: The Full Analysis Set (all randomized patients who received at least one dose of study drug).
The global efficacy was assessed by the patients. The patients answered question below; -Considering all the ways this treatment has affected you since you started the clinical trial, how well are you doing? (5-point Likert scale: 0 = very good, 1 = good, 2 = fair, 3 = poor, and 4 = very poor). \[Global efficacy assessment 1\]
Outcome measures
| Measure |
Active Arm
n=98 Participants
Esflurbiprofen Hydrogel Patch containing 165 mg Esflurbiprofen
|
Control Drug
n=102 Participants
Placebo patch that does not contain the active ingredient but is otherwise indistinguishable from the investigational drug Esflurbiprofen Hydrogel Patch
|
|---|---|---|
|
Global Efficacy Assessments 1 by Patient
48h · Very poor
|
0 Participants
|
2 Participants
|
|
Global Efficacy Assessments 1 by Patient
48h · Poor
|
0 Participants
|
13 Participants
|
|
Global Efficacy Assessments 1 by Patient
48h · Fair
|
15 Participants
|
49 Participants
|
|
Global Efficacy Assessments 1 by Patient
48h · Good
|
47 Participants
|
30 Participants
|
|
Global Efficacy Assessments 1 by Patient
48h · Very good
|
36 Participants
|
8 Participants
|
|
Global Efficacy Assessments 1 by Patient
72h · Very poor
|
0 Participants
|
1 Participants
|
|
Global Efficacy Assessments 1 by Patient
72h · Poor
|
0 Participants
|
13 Participants
|
|
Global Efficacy Assessments 1 by Patient
72h · Fair
|
6 Participants
|
46 Participants
|
|
Global Efficacy Assessments 1 by Patient
72h · Good
|
41 Participants
|
31 Participants
|
|
Global Efficacy Assessments 1 by Patient
72h · Very good
|
51 Participants
|
11 Participants
|
|
Global Efficacy Assessments 1 by Patient
168h · Very poor
|
0 Participants
|
1 Participants
|
|
Global Efficacy Assessments 1 by Patient
168h · Poor
|
0 Participants
|
11 Participants
|
|
Global Efficacy Assessments 1 by Patient
168h · Fair
|
3 Participants
|
42 Participants
|
|
Global Efficacy Assessments 1 by Patient
168h · Good
|
36 Participants
|
31 Participants
|
|
Global Efficacy Assessments 1 by Patient
168h · Very good
|
59 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: 48 h, 72 h, and 168 hPopulation: The Full Analysis Set (all randomized patients who received at least one dose of study drug).
The global efficacy was assessed by the patients. The patients answered question below -How do you rate this medication as treatment for your soft injury/contusion? (5-point Likert scale: 0 = excellent, 1 = very good, 2 = good, 3 = fair, and 4 = poor). \[Global efficacy assessment 2\]
Outcome measures
| Measure |
Active Arm
n=98 Participants
Esflurbiprofen Hydrogel Patch containing 165 mg Esflurbiprofen
|
Control Drug
n=102 Participants
Placebo patch that does not contain the active ingredient but is otherwise indistinguishable from the investigational drug Esflurbiprofen Hydrogel Patch
|
|---|---|---|
|
Global Efficacy Assessments 2 by Patient
48h · Poor
|
0 Participants
|
11 Participants
|
|
Global Efficacy Assessments 2 by Patient
48h · Fair
|
12 Participants
|
35 Participants
|
|
Global Efficacy Assessments 2 by Patient
48h · Good
|
28 Participants
|
36 Participants
|
|
Global Efficacy Assessments 2 by Patient
48h · Very good
|
47 Participants
|
15 Participants
|
|
Global Efficacy Assessments 2 by Patient
48h · Excellent
|
11 Participants
|
5 Participants
|
|
Global Efficacy Assessments 2 by Patient
72h · Poor
|
0 Participants
|
13 Participants
|
|
Global Efficacy Assessments 2 by Patient
72h · Fair
|
7 Participants
|
36 Participants
|
|
Global Efficacy Assessments 2 by Patient
72h · Good
|
27 Participants
|
32 Participants
|
|
Global Efficacy Assessments 2 by Patient
72h · Very good
|
50 Participants
|
12 Participants
|
|
Global Efficacy Assessments 2 by Patient
72h · Excellent
|
14 Participants
|
9 Participants
|
|
Global Efficacy Assessments 2 by Patient
168h · Poor
|
0 Participants
|
12 Participants
|
|
Global Efficacy Assessments 2 by Patient
168h · Fair
|
7 Participants
|
29 Participants
|
|
Global Efficacy Assessments 2 by Patient
168h · Good
|
24 Participants
|
37 Participants
|
|
Global Efficacy Assessments 2 by Patient
168h · Very good
|
46 Participants
|
13 Participants
|
|
Global Efficacy Assessments 2 by Patient
168h · Excellent
|
21 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 48 h, 72 h, and 168 hPopulation: The Full Analysis Set (all randomized patients who received at least one dose of study drug).
The global efficacy was assessed by the investigator. -Considering all the ways this treatment has affected you since you started the clinical trial, how well are you doing? (5-point Likert scale: 0 = very good, 1 = good, 2 = fair, 3 = poor, and 4 = very poor). \[Global efficacy assessment 1\]
Outcome measures
| Measure |
Active Arm
n=98 Participants
Esflurbiprofen Hydrogel Patch containing 165 mg Esflurbiprofen
|
Control Drug
n=102 Participants
Placebo patch that does not contain the active ingredient but is otherwise indistinguishable from the investigational drug Esflurbiprofen Hydrogel Patch
|
|---|---|---|
|
Global Efficacy Assessments 1 by Investigator
48h · Very poor
|
0 Participants
|
1 Participants
|
|
Global Efficacy Assessments 1 by Investigator
48h · Poor
|
1 Participants
|
20 Participants
|
|
Global Efficacy Assessments 1 by Investigator
48h · Fair
|
15 Participants
|
45 Participants
|
|
Global Efficacy Assessments 1 by Investigator
48h · Good
|
35 Participants
|
17 Participants
|
|
Global Efficacy Assessments 1 by Investigator
48h · Very good
|
47 Participants
|
19 Participants
|
|
Global Efficacy Assessments 1 by Investigator
72h · Very poor
|
0 Participants
|
0 Participants
|
|
Global Efficacy Assessments 1 by Investigator
72h · Poor
|
0 Participants
|
22 Participants
|
|
Global Efficacy Assessments 1 by Investigator
72h · Fair
|
8 Participants
|
46 Participants
|
|
Global Efficacy Assessments 1 by Investigator
72h · Good
|
35 Participants
|
14 Participants
|
|
Global Efficacy Assessments 1 by Investigator
72h · Very good
|
55 Participants
|
20 Participants
|
|
Global Efficacy Assessments 1 by Investigator
168h · Very poor
|
0 Participants
|
1 Participants
|
|
Global Efficacy Assessments 1 by Investigator
168h · Poor
|
0 Participants
|
19 Participants
|
|
Global Efficacy Assessments 1 by Investigator
168h · Fair
|
8 Participants
|
42 Participants
|
|
Global Efficacy Assessments 1 by Investigator
168h · Good
|
31 Participants
|
19 Participants
|
|
Global Efficacy Assessments 1 by Investigator
168h · Very good
|
59 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: 0-168hPopulation: The Full Analysis Set (all randomized patients who received at least one dose of study drug).
Rescue medication (paracetamol, 500 mg tablets, up to 3000 mg daily) was allowed during the study, except for the 6 hours prior to V5 (72 h).
Outcome measures
| Measure |
Active Arm
n=98 Participants
Esflurbiprofen Hydrogel Patch containing 165 mg Esflurbiprofen
|
Control Drug
n=102 Participants
Placebo patch that does not contain the active ingredient but is otherwise indistinguishable from the investigational drug Esflurbiprofen Hydrogel Patch
|
|---|---|---|
|
Use of Rescue Medication
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 168hPopulation: The Full Analysis Set (all randomized patients who received at least one dose of study drug).
Resolution of soft tissue injury/contusion was assessed by the Investigator at Visit 7 (168h).
Outcome measures
| Measure |
Active Arm
n=98 Participants
Esflurbiprofen Hydrogel Patch containing 165 mg Esflurbiprofen
|
Control Drug
n=102 Participants
Placebo patch that does not contain the active ingredient but is otherwise indistinguishable from the investigational drug Esflurbiprofen Hydrogel Patch
|
|---|---|---|
|
Resolution of Soft Tissue Injury/Contusion
|
92 Participants
|
49 Participants
|
SECONDARY outcome
Timeframe: 0-24 h, 0-48 h, 0-72 h, and 0-96 hPopulation: The Full Analysis Set (all randomized patients who received at least one dose of study drug).
The sum of pain intensity difference (SPID) of POM on VAS changes over 0-24 h, 0-48 h, 0-72 h, and 0-96 h were calculated. SPID was calculated as the area under the curve of the VAS difference from baseline value.
Outcome measures
| Measure |
Active Arm
n=98 Participants
Esflurbiprofen Hydrogel Patch containing 165 mg Esflurbiprofen
|
Control Drug
n=102 Participants
Placebo patch that does not contain the active ingredient but is otherwise indistinguishable from the investigational drug Esflurbiprofen Hydrogel Patch
|
|---|---|---|
|
SPID of POM VAS Changes
0-24 h
|
342.5 SPID of POM on VAS (mm x h)
Interval -36.0 to 1003.0
|
126.6 SPID of POM on VAS (mm x h)
Interval -86.0 to 518.0
|
|
SPID of POM VAS Changes
0-48 h
|
1211.1 SPID of POM on VAS (mm x h)
Interval 423.0 to 2346.0
|
445.9 SPID of POM on VAS (mm x h)
Interval -75.0 to 1614.0
|
|
SPID of POM VAS Changes
0-72 h
|
2425.1 SPID of POM on VAS (mm x h)
Interval 1133.0 to 4122.0
|
965.5 SPID of POM on VAS (mm x h)
Interval -51.0 to 2982.0
|
|
SPID of POM VAS Changes
0-96 h
|
3881.4 SPID of POM on VAS (mm x h)
Interval 2156.0 to 5970.0
|
1753.7 SPID of POM on VAS (mm x h)
Interval 21.0 to 4178.0
|
SECONDARY outcome
Timeframe: 168hPopulation: The Full Analysis Set (all randomized patients who received at least one dose of study drug).
defined as the percentage of patients able to resume training/normal physical activity by 168 hours
Outcome measures
| Measure |
Active Arm
n=98 Participants
Esflurbiprofen Hydrogel Patch containing 165 mg Esflurbiprofen
|
Control Drug
n=102 Participants
Placebo patch that does not contain the active ingredient but is otherwise indistinguishable from the investigational drug Esflurbiprofen Hydrogel Patch
|
|---|---|---|
|
Responder Rate 2 at 168h
|
92 Participants
|
49 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12h for day 1, 24h for day 1-5 and 7 after application of each patchPopulation: The Full Analysis Set (all randomized patients who received at least one dose of study drug).
Adhesive power of the patch measured by a 5 point numerical scale (0= ≥ 90 % adhered, 1= ≥ 75 % to \< 90 % adhered, 2= ≥ 50 % to \< 75 % adhered, 3= \> 0 % to \<50 % adhered, 4=completely detached) at every visit except V1.
Outcome measures
| Measure |
Active Arm
n=490 Number of patches
Esflurbiprofen Hydrogel Patch containing 165 mg Esflurbiprofen
|
Control Drug
n=510 Number of patches
Placebo patch that does not contain the active ingredient but is otherwise indistinguishable from the investigational drug Esflurbiprofen Hydrogel Patch
|
|---|---|---|
|
Adhesive Power of the Patch
12h · Completely detached
|
1 Number of patches
|
0 Number of patches
|
|
Adhesive Power of the Patch
12h · ≥ 0 % to < 50 % adhered
|
0 Number of patches
|
4 Number of patches
|
|
Adhesive Power of the Patch
12h · ≥ 50 % to < 75 % adhered
|
23 Number of patches
|
27 Number of patches
|
|
Adhesive Power of the Patch
12h · ≥ 75 % to < 90 % adhered
|
46 Number of patches
|
51 Number of patches
|
|
Adhesive Power of the Patch
12h · ≥ 90 % adhered
|
28 Number of patches
|
20 Number of patches
|
|
Adhesive Power of the Patch
24h · Completely detached
|
0 Number of patches
|
1 Number of patches
|
|
Adhesive Power of the Patch
24h · ≥ 0 % to < 50 % adhered
|
10 Number of patches
|
10 Number of patches
|
|
Adhesive Power of the Patch
24h · ≥ 50 % to < 75 % adhered
|
101 Number of patches
|
145 Number of patches
|
|
Adhesive Power of the Patch
24h · ≥ 75 % to < 90 % adhered
|
202 Number of patches
|
206 Number of patches
|
|
Adhesive Power of the Patch
24h · ≥ 90 % adhered
|
177 Number of patches
|
148 Number of patches
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24, 48, 72, 96, 168hPopulation: Safety Set (SAF) The safety set included all randomized patients who received at least one dose of the study drug.
Local tolerability was assessed by the Investigator according to the following numerical scale: 0: No evidence of irritation 1. Minimal erythema, barely perceptible 2. Definite erythema, readily visible, minimal edema or minimal papular response 3. Erythema and papules 4. Definite edema 5. Erythema, edema and papules 6. Vesicular eruption 7. Strong reaction spreading beyond test site
Outcome measures
| Measure |
Active Arm
n=98 Participants
Esflurbiprofen Hydrogel Patch containing 165 mg Esflurbiprofen
|
Control Drug
n=102 Participants
Placebo patch that does not contain the active ingredient but is otherwise indistinguishable from the investigational drug Esflurbiprofen Hydrogel Patch
|
|---|---|---|
|
Local Tolerability
24h · Minimal erythema (1)
|
3 Participants
|
4 Participants
|
|
Local Tolerability
24h · No evidence of irritation (0)
|
95 Participants
|
98 Participants
|
|
Local Tolerability
48h · Minimal erythema (1)
|
3 Participants
|
9 Participants
|
|
Local Tolerability
48h · No evidence of irritation (0)
|
95 Participants
|
93 Participants
|
|
Local Tolerability
72h · Minimal erythema (1)
|
4 Participants
|
6 Participants
|
|
Local Tolerability
72h · No evidence of irritation (0)
|
94 Participants
|
96 Participants
|
|
Local Tolerability
96h · Minimal erythema (1)
|
1 Participants
|
4 Participants
|
|
Local Tolerability
96h · No evidence of irritation (0)
|
97 Participants
|
98 Participants
|
|
Local Tolerability
168h · Minimal erythema (1)
|
4 Participants
|
4 Participants
|
|
Local Tolerability
168h · No evidence of irritation (0)
|
94 Participants
|
98 Participants
|
Adverse Events
Active Arm
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Control Drug
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active Arm
n=98 participants at risk
Esflurbiprofen Hydrogel Patch containing 165 mg Esflurbiprofen
|
Control Drug
n=102 participants at risk
Placebo patch that does not contain the active ingredient but is otherwise indistinguishable from the investigational drug Esflurbiprofen Hydrogel Patch
|
|---|---|---|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/98 • From Baseline assessment for up to 7 days (±1 days)
|
0.98%
1/102 • Number of events 1 • From Baseline assessment for up to 7 days (±1 days)
|
|
Infections and infestations
Infection
|
1.0%
1/98 • Number of events 1 • From Baseline assessment for up to 7 days (±1 days)
|
0.00%
0/102 • From Baseline assessment for up to 7 days (±1 days)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.0%
1/98 • Number of events 1 • From Baseline assessment for up to 7 days (±1 days)
|
0.00%
0/102 • From Baseline assessment for up to 7 days (±1 days)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
8.2%
8/98 • Number of events 15 • From Baseline assessment for up to 7 days (±1 days)
|
14.7%
15/102 • Number of events 27 • From Baseline assessment for up to 7 days (±1 days)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place