Trial Outcomes & Findings for Effectiveness of Two Different Doses of BI 1026706 on the Overall Peak-to-Peak (PtP) N2/P2-component Amplitude of Laser (Somatosensory, Radiant-heat) Evoked Potentials (LEP) in UVB(Ultraviolet)-Irradiated Skin in Healthy Male Volunteers (NCT NCT02037165)
NCT ID: NCT02037165
Last Updated: 2019-07-05
Results Overview
Overall Peak-to-Peak (PtP) N2/P2-component amplitude of Laser (somatosensory/radiant heat) evoked potentials (LEP) in UVB-irradiated skin. Treated set (TS)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
25 participants
Primary outcome timeframe
up to 24 hours (h): -2:05h, 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 22:00h, 24:00h (relative to study drug administration [h:min])
Results posted on
2019-07-05
Participant Flow
Participant milestones
| Measure |
50mg BI1026706/200mg BI1026706/Placebo/200mg Cele/150mg Preg
Single dose administration per treatment. A washout period of at least 6 days was required between the treatments. Treatment sequence A: 50mg BI 1026706 (powder for oral solution \[PfOS\]), 200mg BI 1026706 (PfOS), placebo (matching placebo to BI 1026706), 200mg Celecoxib (Cele, hard capsule), 150mg Pregabalin (Preg, hard capsule). Mode of admin.: oral with 200 mL of water.
|
200mg BI1026706/50mg BI1026706/200mg Cele/150mg Preg/Placebo
Single dose administration per treatment. A washout period of at least 6 days was required between the treatments. Treatment sequence B: 200mg BI 1026706 (PfOS), 50mg BI 1026706 (PfOS), 200mg Cele (hard capsule), 150mg Preg (hard capsule), placebo (matching placebo).Mode of admin.: oral with 200 mL of water.
|
Placebo/150mg Preg/50mg BI1026706/200mg BI1026706/200mg Cele
Single dose administration per treatment. A washout period of at least 6 days was required between the treatments. Treatment sequence C: placebo (matching placebo), 150mg Preg (hard capsule), 50mg BI 1026706 (PfOS), 200mg BI 1026706 (PfOS), 200mg Cele (hard capsule). Mode of admin.: oral with 200 mL of water.
|
200mg Cele/Placebo/150mg Preg/50mg BI1026706/200mg BI1026706
Single dose administration per treatment. A washout period of at least 6 days was required between the treatments. Treatment sequence D: 200mg Cele (hard capsule), placebo (matching placebo), 150mg Preg (hard capsule), 50mg BI 1026706 (PfOS), 200mg BI 1026706 (PfOS). Mode of admin.: oral with 200 mL of water.
|
150mg Preg/200mg Cele/200mg BI1026706/Placebo/50mg BI1026706
Single dose administration per treatment. A washout period of at least 6 days was required between the treatments. Treatment sequence E: 150mg Preg (hard capsule), 200mg Cele (hard capsule), 200mg BI 1026706 (PfOS), placebo (matching placebo), 50mg BI 1026706 (PfOS). Mode of admin.: oral with 200 mL of water.
|
|---|---|---|---|---|---|
|
Period 1 (2 Days)
STARTED
|
5
|
5
|
5
|
5
|
5
|
|
Period 1 (2 Days)
COMPLETED
|
5
|
5
|
5
|
5
|
5
|
|
Period 1 (2 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period 1 (6 Days)
STARTED
|
5
|
5
|
5
|
5
|
5
|
|
Washout Period 1 (6 Days)
COMPLETED
|
5
|
5
|
5
|
5
|
5
|
|
Washout Period 1 (6 Days)
NOT COMPLETED
|
0
|
0
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0
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0
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0
|
|
Period 2 (2 Days)
STARTED
|
5
|
5
|
5
|
5
|
5
|
|
Period 2 (2 Days)
COMPLETED
|
5
|
5
|
5
|
5
|
5
|
|
Period 2 (2 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period 2 (6 Days)
STARTED
|
5
|
5
|
5
|
5
|
5
|
|
Washout Period 2 (6 Days)
COMPLETED
|
5
|
5
|
5
|
5
|
5
|
|
Washout Period 2 (6 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Period 3 (2 Days)
STARTED
|
5
|
5
|
5
|
5
|
5
|
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Period 3 (2 Days)
COMPLETED
|
5
|
5
|
5
|
5
|
5
|
|
Period 3 (2 Days)
NOT COMPLETED
|
0
|
0
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0
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0
|
0
|
|
Washout Period 3 (6 Days)
STARTED
|
5
|
5
|
5
|
5
|
5
|
|
Washout Period 3 (6 Days)
COMPLETED
|
5
|
5
|
5
|
5
|
5
|
|
Washout Period 3 (6 Days)
NOT COMPLETED
|
0
|
0
|
0
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0
|
0
|
|
Period 4 (2 Days)
STARTED
|
5
|
5
|
5
|
5
|
5
|
|
Period 4 (2 Days)
COMPLETED
|
5
|
5
|
5
|
5
|
5
|
|
Period 4 (2 Days)
NOT COMPLETED
|
0
|
0
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0
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0
|
0
|
|
Washout Period 4 (6 Days)
STARTED
|
5
|
5
|
5
|
5
|
5
|
|
Washout Period 4 (6 Days)
COMPLETED
|
5
|
5
|
5
|
5
|
4
|
|
Washout Period 4 (6 Days)
NOT COMPLETED
|
0
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0
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0
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0
|
1
|
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Period 5 (2 Days)
STARTED
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5
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5
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5
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5
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4
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Period 5 (2 Days)
COMPLETED
|
5
|
5
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5
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5
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4
|
|
Period 5 (2 Days)
NOT COMPLETED
|
0
|
0
|
0
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0
|
0
|
Reasons for withdrawal
| Measure |
50mg BI1026706/200mg BI1026706/Placebo/200mg Cele/150mg Preg
Single dose administration per treatment. A washout period of at least 6 days was required between the treatments. Treatment sequence A: 50mg BI 1026706 (powder for oral solution \[PfOS\]), 200mg BI 1026706 (PfOS), placebo (matching placebo to BI 1026706), 200mg Celecoxib (Cele, hard capsule), 150mg Pregabalin (Preg, hard capsule). Mode of admin.: oral with 200 mL of water.
|
200mg BI1026706/50mg BI1026706/200mg Cele/150mg Preg/Placebo
Single dose administration per treatment. A washout period of at least 6 days was required between the treatments. Treatment sequence B: 200mg BI 1026706 (PfOS), 50mg BI 1026706 (PfOS), 200mg Cele (hard capsule), 150mg Preg (hard capsule), placebo (matching placebo).Mode of admin.: oral with 200 mL of water.
|
Placebo/150mg Preg/50mg BI1026706/200mg BI1026706/200mg Cele
Single dose administration per treatment. A washout period of at least 6 days was required between the treatments. Treatment sequence C: placebo (matching placebo), 150mg Preg (hard capsule), 50mg BI 1026706 (PfOS), 200mg BI 1026706 (PfOS), 200mg Cele (hard capsule). Mode of admin.: oral with 200 mL of water.
|
200mg Cele/Placebo/150mg Preg/50mg BI1026706/200mg BI1026706
Single dose administration per treatment. A washout period of at least 6 days was required between the treatments. Treatment sequence D: 200mg Cele (hard capsule), placebo (matching placebo), 150mg Preg (hard capsule), 50mg BI 1026706 (PfOS), 200mg BI 1026706 (PfOS). Mode of admin.: oral with 200 mL of water.
|
150mg Preg/200mg Cele/200mg BI1026706/Placebo/50mg BI1026706
Single dose administration per treatment. A washout period of at least 6 days was required between the treatments. Treatment sequence E: 150mg Preg (hard capsule), 200mg Cele (hard capsule), 200mg BI 1026706 (PfOS), placebo (matching placebo), 50mg BI 1026706 (PfOS). Mode of admin.: oral with 200 mL of water.
|
|---|---|---|---|---|---|
|
Washout Period 4 (6 Days)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Effectiveness of Two Different Doses of BI 1026706 on the Overall Peak-to-Peak (PtP) N2/P2-component Amplitude of Laser (Somatosensory, Radiant-heat) Evoked Potentials (LEP) in UVB(Ultraviolet)-Irradiated Skin in Healthy Male Volunteers
Baseline characteristics by cohort
| Measure |
50mg BI1026706/ 200mg BI1026706/Placebo/200mg Cele/150mg Preg
n=5 Participants
Single dose administration per treatment. A washout period of at least 6 days was required between the treatments. Treatment sequence A: 50mg BI 1026706 (PfOS), 200mg BI 1026706 (PfOS), placebo (matching placebo to BI 1026706), 200mg Celecoxib (Cele, hard capsule), 150mg Pregabalin (Preg, hard capsule). Mode of admin.: oral with 200 mL of water.
|
200mg BI1026706/50mg BI1026706/200mg Cele/150mg Preg/Placebo
n=5 Participants
Single dose administration per treatment. A washout period of at least 6 days was required between the treatments. Treatment sequence B: 200mg BI 1026706 (PfOS), 50mg BI 1026706 (PfOS), 200mg Cele (hard capsule), 150mg Preg (hard capsule), placebo (matching placebo). Mode of admin.: oral with 200 mL of water.
|
Placebo/150mg Preg/50mg BI1026706/200mg BI1026706/200mg Cele
n=5 Participants
Single dose administration per treatment. A washout period of at least 6 days was required between the treatments. Treatment sequence C: placebo (matching placebo), 150mg Preg (hard capsule), 50mg BI 1026706 (PfOS), 200mg BI 1026706 (PfOS), 200mg Cele (hard capsule). Mode of admin.: oral with 200 mL of water.
|
200mg Cele/Placebo/150mg Preg/50mg BI1026706/200mg BI1026706
n=5 Participants
Single dose administration per treatment. A washout period of at least 6 days was required between the treatments. Treatment sequence D: 200mg Cele (hard capsule), placebo (matching placebo), 150mg Preg (hard capsule), 50mg BI 1026706 (PfOS), 200mg BI 1026706 (PfOS). Mode of admin.: oral with 200 mL of water.
|
150mg Preg/200mg Cele/200mg BI1026706/Placebo/50mg BI1026706
n=5 Participants
Single dose administration per treatment. A washout period of at least 6 days was required between the treatments. Treatment sequence E: 150mg Preg (hard capsule), 200mg Cele (hard capsule), 200mg BI 1026706 (hard capsule), placebo (matching placebo), 50mg BI 1026706 (PfOS). Mode of admin.: oral with 200 mL of water.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
31.2 years
STANDARD_DEVIATION 10.3 • n=99 Participants
|
35.8 years
STANDARD_DEVIATION 11.6 • n=107 Participants
|
41.2 years
STANDARD_DEVIATION 10.9 • n=206 Participants
|
35.0 years
STANDARD_DEVIATION 11.2 • n=7 Participants
|
32.8 years
STANDARD_DEVIATION 7.9 • n=31 Participants
|
35.2 years
STANDARD_DEVIATION 10.2 • n=30 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
25 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: up to 24 hours (h): -2:05h, 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 22:00h, 24:00h (relative to study drug administration [h:min])Population: pharmacodynamic set(PDS): included all subjects from the TS who provided in any treatment period a baseline value and at least 1 PD profile post drug administration for the primary or secondary PD endpoint, which was considered evaluable, and without (important) protocol violation(s) with respect to the statistical evaluation of PD endpoints.
Overall Peak-to-Peak (PtP) N2/P2-component amplitude of Laser (somatosensory/radiant heat) evoked potentials (LEP) in UVB-irradiated skin. Treated set (TS)
Outcome measures
| Measure |
Placebo
n=25 Participants
Matching placebo to BI 1026706, Mode of Administration: Oral with 200 mL of water.
|
50 mg BI 1026706
n=24 Participants
treatment group: 50 mg BI 1026706, powder for oral solution (PfOS), Mode of Admin.: Oral with 200 mL of water.
|
200 mg BI 1026706
n=25 Participants
treatment group: 200 mg BI 1026706, powder for oral solution (PfOS), Mode of Admin.: Oral with 200 mL of water.
|
200 mg Celecoxib (Cele)
n=25 Participants
200 mg Celecoxib (cele), hard capsule, single dose, mode of admin.: oral with 200 mL of water.
|
|---|---|---|---|---|
|
Overall Peak-to-Peak(PtP) N2/P2-component Amplitude of Laser (Somatosensory/Radiant Heat) Evoked Potentials (LEP) in Ultraviolet B (UVB) -Irradiated Skin
at 0:30h
|
27.84 Microvolts (µv)
Standard Deviation 8.83
|
28.00 Microvolts (µv)
Standard Deviation 10.67
|
24.88 Microvolts (µv)
Standard Deviation 8.69
|
26.60 Microvolts (µv)
Standard Deviation 8.90
|
|
Overall Peak-to-Peak(PtP) N2/P2-component Amplitude of Laser (Somatosensory/Radiant Heat) Evoked Potentials (LEP) in Ultraviolet B (UVB) -Irradiated Skin
at -2:05h
|
29.22 Microvolts (µv)
Standard Deviation 8.98
|
26.08 Microvolts (µv)
Standard Deviation 10.41
|
28.93 Microvolts (µv)
Standard Deviation 8.06
|
26.35 Microvolts (µv)
Standard Deviation 9.22
|
|
Overall Peak-to-Peak(PtP) N2/P2-component Amplitude of Laser (Somatosensory/Radiant Heat) Evoked Potentials (LEP) in Ultraviolet B (UVB) -Irradiated Skin
at 1:00h
|
25.57 Microvolts (µv)
Standard Deviation 10.02
|
27.11 Microvolts (µv)
Standard Deviation 8.64
|
26.77 Microvolts (µv)
Standard Deviation 10.31
|
27.60 Microvolts (µv)
Standard Deviation 9.31
|
|
Overall Peak-to-Peak(PtP) N2/P2-component Amplitude of Laser (Somatosensory/Radiant Heat) Evoked Potentials (LEP) in Ultraviolet B (UVB) -Irradiated Skin
at 2:00h
|
26.74 Microvolts (µv)
Standard Deviation 8.51
|
28.78 Microvolts (µv)
Standard Deviation 8.81
|
29.03 Microvolts (µv)
Standard Deviation 9.04
|
24.87 Microvolts (µv)
Standard Deviation 7.11
|
|
Overall Peak-to-Peak(PtP) N2/P2-component Amplitude of Laser (Somatosensory/Radiant Heat) Evoked Potentials (LEP) in Ultraviolet B (UVB) -Irradiated Skin
at 3:00h
|
29.48 Microvolts (µv)
Standard Deviation 9.50
|
30.93 Microvolts (µv)
Standard Deviation 7.39
|
29.02 Microvolts (µv)
Standard Deviation 7.98
|
25.05 Microvolts (µv)
Standard Deviation 8.32
|
|
Overall Peak-to-Peak(PtP) N2/P2-component Amplitude of Laser (Somatosensory/Radiant Heat) Evoked Potentials (LEP) in Ultraviolet B (UVB) -Irradiated Skin
at 4:00h
|
30.54 Microvolts (µv)
Standard Deviation 8.77
|
31.40 Microvolts (µv)
Standard Deviation 10.90
|
31.44 Microvolts (µv)
Standard Deviation 8.42
|
23.97 Microvolts (µv)
Standard Deviation 7.71
|
|
Overall Peak-to-Peak(PtP) N2/P2-component Amplitude of Laser (Somatosensory/Radiant Heat) Evoked Potentials (LEP) in Ultraviolet B (UVB) -Irradiated Skin
at 5:00h
|
31.74 Microvolts (µv)
Standard Deviation 10.07
|
30.10 Microvolts (µv)
Standard Deviation 8.37
|
30.79 Microvolts (µv)
Standard Deviation 9.84
|
24.10 Microvolts (µv)
Standard Deviation 8.78
|
|
Overall Peak-to-Peak(PtP) N2/P2-component Amplitude of Laser (Somatosensory/Radiant Heat) Evoked Potentials (LEP) in Ultraviolet B (UVB) -Irradiated Skin
at 6:00h
|
32.16 Microvolts (µv)
Standard Deviation 10.48
|
28.12 Microvolts (µv)
Standard Deviation 8.29
|
29.04 Microvolts (µv)
Standard Deviation 10.66
|
26.77 Microvolts (µv)
Standard Deviation 8.61
|
|
Overall Peak-to-Peak(PtP) N2/P2-component Amplitude of Laser (Somatosensory/Radiant Heat) Evoked Potentials (LEP) in Ultraviolet B (UVB) -Irradiated Skin
at 22:00h
|
34.48 Microvolts (µv)
Standard Deviation 10.97
|
32.51 Microvolts (µv)
Standard Deviation 8.30
|
34.50 Microvolts (µv)
Standard Deviation 10.97
|
33.06 Microvolts (µv)
Standard Deviation 11.33
|
|
Overall Peak-to-Peak(PtP) N2/P2-component Amplitude of Laser (Somatosensory/Radiant Heat) Evoked Potentials (LEP) in Ultraviolet B (UVB) -Irradiated Skin
at 24:00h
|
34.43 Microvolts (µv)
Standard Deviation 16.61
|
32.83 Microvolts (µv)
Standard Deviation 9.62
|
32.98 Microvolts (µv)
Standard Deviation 12.31
|
30.03 Microvolts (µv)
Standard Deviation 10.54
|
SECONDARY outcome
Timeframe: up to 24 hours(h): -1:20h, 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 22:00h, 24:00h (relative to study drug administration [h:min])Population: PDS
Overall Peak-to-Peak (PtP) N2/P2-component amplitude of (LEP) in capsaicin-irritated skin.
Outcome measures
| Measure |
Placebo
n=25 Participants
Matching placebo to BI 1026706, Mode of Administration: Oral with 200 mL of water.
|
50 mg BI 1026706
n=24 Participants
treatment group: 50 mg BI 1026706, powder for oral solution (PfOS), Mode of Admin.: Oral with 200 mL of water.
|
200 mg BI 1026706
n=25 Participants
treatment group: 200 mg BI 1026706, powder for oral solution (PfOS), Mode of Admin.: Oral with 200 mL of water.
|
200 mg Celecoxib (Cele)
n=25 Participants
200 mg Celecoxib (cele), hard capsule, single dose, mode of admin.: oral with 200 mL of water.
|
|---|---|---|---|---|
|
Overall Peak-to-Peak (PtP) N2/P2-component Amplitude of (LEP) in Capsaicin-irritated Skin
at -1:20h
|
21.17 µv
Standard Deviation 10.33
|
18.53 µv
Standard Deviation 6.88
|
19.57 µv
Standard Deviation 9.24
|
22.44 µv
Standard Deviation 10.94
|
|
Overall Peak-to-Peak (PtP) N2/P2-component Amplitude of (LEP) in Capsaicin-irritated Skin
at 0:30h
|
27.21 µv
Standard Deviation 10.36
|
25.00 µv
Standard Deviation 9.69
|
25.35 µv
Standard Deviation 9.12
|
25.20 µv
Standard Deviation 10.61
|
|
Overall Peak-to-Peak (PtP) N2/P2-component Amplitude of (LEP) in Capsaicin-irritated Skin
at 1:00h
|
27.96 µv
Standard Deviation 9.38
|
23.67 µv
Standard Deviation 10.49
|
23.11 µv
Standard Deviation 8.96
|
24.80 µv
Standard Deviation 9.89
|
|
Overall Peak-to-Peak (PtP) N2/P2-component Amplitude of (LEP) in Capsaicin-irritated Skin
at 2:00h
|
27.97 µv
Standard Deviation 9.32
|
23.94 µv
Standard Deviation 8.40
|
24.98 µv
Standard Deviation 7.29
|
24.83 µv
Standard Deviation 10.89
|
|
Overall Peak-to-Peak (PtP) N2/P2-component Amplitude of (LEP) in Capsaicin-irritated Skin
at 3:00h
|
27.69 µv
Standard Deviation 8.74
|
25.68 µv
Standard Deviation 8.20
|
26.13 µv
Standard Deviation 9.35
|
24.46 µv
Standard Deviation 9.58
|
|
Overall Peak-to-Peak (PtP) N2/P2-component Amplitude of (LEP) in Capsaicin-irritated Skin
at 4:00h
|
27.53 µv
Standard Deviation 9.19
|
26.74 µv
Standard Deviation 6.99
|
25.26 µv
Standard Deviation 8.33
|
22.76 µv
Standard Deviation 9.37
|
|
Overall Peak-to-Peak (PtP) N2/P2-component Amplitude of (LEP) in Capsaicin-irritated Skin
at 5:00h
|
26.25 µv
Standard Deviation 9.39
|
25.81 µv
Standard Deviation 9.44
|
25.31 µv
Standard Deviation 8.06
|
23.00 µv
Standard Deviation 10.03
|
|
Overall Peak-to-Peak (PtP) N2/P2-component Amplitude of (LEP) in Capsaicin-irritated Skin
at 6:00h
|
25.77 µv
Standard Deviation 9.10
|
24.14 µv
Standard Deviation 8.33
|
24.06 µv
Standard Deviation 8.24
|
23.30 µv
Standard Deviation 9.18
|
|
Overall Peak-to-Peak (PtP) N2/P2-component Amplitude of (LEP) in Capsaicin-irritated Skin
at 22:00h
|
26.75 µv
Standard Deviation 9.00
|
24.46 µv
Standard Deviation 9.07
|
23.53 µv
Standard Deviation 8.44
|
23.15 µv
Standard Deviation 8.24
|
|
Overall Peak-to-Peak (PtP) N2/P2-component Amplitude of (LEP) in Capsaicin-irritated Skin
at 24:00h
|
24.83 µv
Standard Deviation 8.77
|
22.94 µv
Standard Deviation 8.06
|
23.91 µv
Standard Deviation 11.18
|
22.59 µv
Standard Deviation 9.71
|
SECONDARY outcome
Timeframe: up to 24 hours(h): -2:05h, 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 22:00h, 24:00h (relative to study drug administration [h:min])Population: PDS
Single "peripheral" N2-component amplitudes - measured in UVB-irradiated skin type.
Outcome measures
| Measure |
Placebo
n=25 Participants
Matching placebo to BI 1026706, Mode of Administration: Oral with 200 mL of water.
|
50 mg BI 1026706
n=24 Participants
treatment group: 50 mg BI 1026706, powder for oral solution (PfOS), Mode of Admin.: Oral with 200 mL of water.
|
200 mg BI 1026706
n=25 Participants
treatment group: 200 mg BI 1026706, powder for oral solution (PfOS), Mode of Admin.: Oral with 200 mL of water.
|
200 mg Celecoxib (Cele)
n=25 Participants
200 mg Celecoxib (cele), hard capsule, single dose, mode of admin.: oral with 200 mL of water.
|
|---|---|---|---|---|
|
Single "Peripheral" N2-component Amplitudes - Measured in UVB-irradiated Skin Type
at 1:00h
|
12.54 µv
Standard Deviation 5.15
|
14.42 µv
Standard Deviation 5.76
|
13.45 µv
Standard Deviation 5.34
|
14.29 µv
Standard Deviation 4.67
|
|
Single "Peripheral" N2-component Amplitudes - Measured in UVB-irradiated Skin Type
at 2:00h
|
14.40 µv
Standard Deviation 4.37
|
14.90 µv
Standard Deviation 5.50
|
15.06 µv
Standard Deviation 4.48
|
12.22 µv
Standard Deviation 3.59
|
|
Single "Peripheral" N2-component Amplitudes - Measured in UVB-irradiated Skin Type
at 4:00h
|
16.52 µv
Standard Deviation 4.99
|
16.92 µv
Standard Deviation 5.37
|
16.95 µv
Standard Deviation 4.27
|
11.87 µv
Standard Deviation 4.35
|
|
Single "Peripheral" N2-component Amplitudes - Measured in UVB-irradiated Skin Type
at 5:00h
|
17.20 µv
Standard Deviation 5.37
|
16.87 µv
Standard Deviation 4.81
|
16.93 µv
Standard Deviation 5.69
|
12.07 µv
Standard Deviation 4.68
|
|
Single "Peripheral" N2-component Amplitudes - Measured in UVB-irradiated Skin Type
at 6:00h
|
17.46 µv
Standard Deviation 5.77
|
15.51 µv
Standard Deviation 5.28
|
15.30 µv
Standard Deviation 4.94
|
14.04 µv
Standard Deviation 5.51
|
|
Single "Peripheral" N2-component Amplitudes - Measured in UVB-irradiated Skin Type
at 22:00h
|
18.71 µv
Standard Deviation 6.36
|
17.12 µv
Standard Deviation 5.23
|
18.93 µv
Standard Deviation 6.11
|
16.99 µv
Standard Deviation 6.35
|
|
Single "Peripheral" N2-component Amplitudes - Measured in UVB-irradiated Skin Type
at 24:00h
|
19.01 µv
Standard Deviation 8.69
|
17.74 µv
Standard Deviation 5.31
|
18.58 µv
Standard Deviation 6.55
|
16.67 µv
Standard Deviation 5.84
|
|
Single "Peripheral" N2-component Amplitudes - Measured in UVB-irradiated Skin Type
at -2:05h
|
14.62 µv
Standard Deviation 4.02
|
12.78 µv
Standard Deviation 6.42
|
14.25 µv
Standard Deviation 4.73
|
13.45 µv
Standard Deviation 5.61
|
|
Single "Peripheral" N2-component Amplitudes - Measured in UVB-irradiated Skin Type
at 0:30h
|
14.48 µv
Standard Deviation 5.01
|
13.77 µv
Standard Deviation 6.03
|
12.70 µv
Standard Deviation 4.99
|
13.62 µv
Standard Deviation 4.55
|
|
Single "Peripheral" N2-component Amplitudes - Measured in UVB-irradiated Skin Type
at 3:00h
|
16.08 µv
Standard Deviation 4.74
|
16.85 µv
Standard Deviation 5.08
|
14.58 µv
Standard Deviation 3.93
|
12.61 µv
Standard Deviation 4.36
|
SECONDARY outcome
Timeframe: up to 24 hours(h): -1:20h, 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 22:00h, 24:00h (relative to study drug administration [h:min])Population: PDS
Single "peripheral" N2-component amplitudes - measured in capsaicin-irritated skin type.
Outcome measures
| Measure |
Placebo
n=25 Participants
Matching placebo to BI 1026706, Mode of Administration: Oral with 200 mL of water.
|
50 mg BI 1026706
n=24 Participants
treatment group: 50 mg BI 1026706, powder for oral solution (PfOS), Mode of Admin.: Oral with 200 mL of water.
|
200 mg BI 1026706
n=25 Participants
treatment group: 200 mg BI 1026706, powder for oral solution (PfOS), Mode of Admin.: Oral with 200 mL of water.
|
200 mg Celecoxib (Cele)
n=25 Participants
200 mg Celecoxib (cele), hard capsule, single dose, mode of admin.: oral with 200 mL of water.
|
|---|---|---|---|---|
|
Single "Peripheral" N2-component Amplitudes - Measured in Capsaicin-irritated Skin Type
at -1:20h
|
10.42 µv
Standard Deviation 5.76
|
9.65 µv
Standard Deviation 4.63
|
9.27 µv
Standard Deviation 5.47
|
10.99 µv
Standard Deviation 5.89
|
|
Single "Peripheral" N2-component Amplitudes - Measured in Capsaicin-irritated Skin Type
at 0:30h
|
13.95 µv
Standard Deviation 5.59
|
12.73 µv
Standard Deviation 5.03
|
12.17 µv
Standard Deviation 5.30
|
12.17 µv
Standard Deviation 6.39
|
|
Single "Peripheral" N2-component Amplitudes - Measured in Capsaicin-irritated Skin Type
at 1:00h
|
13.70 µv
Standard Deviation 5.27
|
11.43 µv
Standard Deviation 5.83
|
11.50 µv
Standard Deviation 5.48
|
12.03 µv
Standard Deviation 5.34
|
|
Single "Peripheral" N2-component Amplitudes - Measured in Capsaicin-irritated Skin Type
at 2:00h
|
13.77 µv
Standard Deviation 5.39
|
11.85 µv
Standard Deviation 4.94
|
12.36 µv
Standard Deviation 4.43
|
12.18 µv
Standard Deviation 6.26
|
|
Single "Peripheral" N2-component Amplitudes - Measured in Capsaicin-irritated Skin Type
at 3:00h
|
13.44 µv
Standard Deviation 5.07
|
12.71 µv
Standard Deviation 5.59
|
13.39 µv
Standard Deviation 5.23
|
12.51 µv
Standard Deviation 6.20
|
|
Single "Peripheral" N2-component Amplitudes - Measured in Capsaicin-irritated Skin Type
at 4:00h
|
13.52 µv
Standard Deviation 4.40
|
13.54 µv
Standard Deviation 4.58
|
12.63 µv
Standard Deviation 4.20
|
10.86 µv
Standard Deviation 6.05
|
|
Single "Peripheral" N2-component Amplitudes - Measured in Capsaicin-irritated Skin Type
at 5:00h
|
12.93 µv
Standard Deviation 4.11
|
13.01 µv
Standard Deviation 5.65
|
12.84 µv
Standard Deviation 4.70
|
11.49 µv
Standard Deviation 6.45
|
|
Single "Peripheral" N2-component Amplitudes - Measured in Capsaicin-irritated Skin Type
at 6:00h
|
12.36 µv
Standard Deviation 5.43
|
12.27 µv
Standard Deviation 5.52
|
12.27 µv
Standard Deviation 4.46
|
12.03 µv
Standard Deviation 5.39
|
|
Single "Peripheral" N2-component Amplitudes - Measured in Capsaicin-irritated Skin Type
at 22:00h
|
13.59 µv
Standard Deviation 5.03
|
12.84 µv
Standard Deviation 5.68
|
11.53 µv
Standard Deviation 4.95
|
11.77 µv
Standard Deviation 5.39
|
|
Single "Peripheral" N2-component Amplitudes - Measured in Capsaicin-irritated Skin Type
at 24:00h
|
13.18 µv
Standard Deviation 5.83
|
11.71 µv
Standard Deviation 4.87
|
11.70 µv
Standard Deviation 5.66
|
11.35 µv
Standard Deviation 5.53
|
SECONDARY outcome
Timeframe: up to 24 hours(h): -2:05h, 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 22:00h, 24:00h (relative to study drug administration [h:min])Population: PDS
Single "central" P2-component amplitudes - measured in UVB-irradiated skin type.
Outcome measures
| Measure |
Placebo
n=25 Participants
Matching placebo to BI 1026706, Mode of Administration: Oral with 200 mL of water.
|
50 mg BI 1026706
n=24 Participants
treatment group: 50 mg BI 1026706, powder for oral solution (PfOS), Mode of Admin.: Oral with 200 mL of water.
|
200 mg BI 1026706
n=25 Participants
treatment group: 200 mg BI 1026706, powder for oral solution (PfOS), Mode of Admin.: Oral with 200 mL of water.
|
200 mg Celecoxib (Cele)
n=25 Participants
200 mg Celecoxib (cele), hard capsule, single dose, mode of admin.: oral with 200 mL of water.
|
|---|---|---|---|---|
|
Single "Central" P2-component Amplitudes - Measured in UVB-irradiated Skin Type
UVB, at -2:05h
|
14.59 µv
Standard Deviation 6.57
|
13.31 µv
Standard Deviation 5.43
|
14.68 µv
Standard Deviation 4.83
|
12.90 µv
Standard Deviation 5.08
|
|
Single "Central" P2-component Amplitudes - Measured in UVB-irradiated Skin Type
UVB, at 0:30h
|
14.06 µv
Standard Deviation 6.24
|
14.23 µv
Standard Deviation 6.26
|
12.18 µv
Standard Deviation 4.82
|
12.98 µv
Standard Deviation 5.86
|
|
Single "Central" P2-component Amplitudes - Measured in UVB-irradiated Skin Type
UVB, at 1:00h
|
13.03 µv
Standard Deviation 6.66
|
12.69 µv
Standard Deviation 5.21
|
13.32 µv
Standard Deviation 6.28
|
13.31 µv
Standard Deviation 5.52
|
|
Single "Central" P2-component Amplitudes - Measured in UVB-irradiated Skin Type
UVB, at 2:00h
|
12.34 µv
Standard Deviation 5.79
|
13.88 µv
Standard Deviation 5.30
|
13.97 µv
Standard Deviation 5.99
|
12.65 µv
Standard Deviation 4.56
|
|
Single "Central" P2-component Amplitudes - Measured in UVB-irradiated Skin Type
UVB, at 3:00h
|
13.40 µv
Standard Deviation 6.37
|
14.08 µv
Standard Deviation 4.99
|
14.44 µv
Standard Deviation 6.16
|
12.44 µv
Standard Deviation 5.59
|
|
Single "Central" P2-component Amplitudes - Measured in UVB-irradiated Skin Type
UVB, at 4:00h
|
14.01 µv
Standard Deviation 6.07
|
14.49 µv
Standard Deviation 7.11
|
14.49 µv
Standard Deviation 6.04
|
12.10 µv
Standard Deviation 5.11
|
|
Single "Central" P2-component Amplitudes - Measured in UVB-irradiated Skin Type
UVB, at 5:00h
|
14.54 µv
Standard Deviation 6.53
|
13.23 µv
Standard Deviation 5.38
|
13.87 µv
Standard Deviation 6.71
|
12.03 µv
Standard Deviation 5.81
|
|
Single "Central" P2-component Amplitudes - Measured in UVB-irradiated Skin Type
UVB, at 6:00h
|
14.71 µv
Standard Deviation 6.58
|
12.61 µv
Standard Deviation 5.16
|
13.74 µv
Standard Deviation 7.30
|
12.73 µv
Standard Deviation 4.95
|
|
Single "Central" P2-component Amplitudes - Measured in UVB-irradiated Skin Type
UVB, at 22:00h
|
15.77 µv
Standard Deviation 6.59
|
15.40 µv
Standard Deviation 5.36
|
15.57 µv
Standard Deviation 8.02
|
16.07 µv
Standard Deviation 6.61
|
|
Single "Central" P2-component Amplitudes - Measured in UVB-irradiated Skin Type
UVB, at 24:00h
|
15.43 µv
Standard Deviation 9.07
|
15.09 µv
Standard Deviation 6.23
|
14.40 µv
Standard Deviation 7.63
|
13.36 µv
Standard Deviation 5.73
|
SECONDARY outcome
Timeframe: up to 24 hours(h): -1:20h, 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 22:00h, 24:00h (relative to study drug administration [h:min])Population: PDS
Single "central" P2-component amplitudes - measured in capsaicin-irritated skin type.
Outcome measures
| Measure |
Placebo
n=25 Participants
Matching placebo to BI 1026706, Mode of Administration: Oral with 200 mL of water.
|
50 mg BI 1026706
n=24 Participants
treatment group: 50 mg BI 1026706, powder for oral solution (PfOS), Mode of Admin.: Oral with 200 mL of water.
|
200 mg BI 1026706
n=25 Participants
treatment group: 200 mg BI 1026706, powder for oral solution (PfOS), Mode of Admin.: Oral with 200 mL of water.
|
200 mg Celecoxib (Cele)
n=25 Participants
200 mg Celecoxib (cele), hard capsule, single dose, mode of admin.: oral with 200 mL of water.
|
|---|---|---|---|---|
|
Single "Central" P2-component Amplitudes - Measured in Capsaicin-irritated Skin Type
at -1:20h
|
10.75 µv
Standard Deviation 5.43
|
8.88 µv
Standard Deviation 3.80
|
10.30 µv
Standard Deviation 4.51
|
11.45 µv
Standard Deviation 6.12
|
|
Single "Central" P2-component Amplitudes - Measured in Capsaicin-irritated Skin Type
at 0:30h
|
13.83 µv
Standard Deviation 6.53
|
12.27 µv
Standard Deviation 5.76
|
13.18 µv
Standard Deviation 5.22
|
13.03 µv
Standard Deviation 5.59
|
|
Single "Central" P2-component Amplitudes - Measured in Capsaicin-irritated Skin Type
at 1:00h
|
14.25 µv
Standard Deviation 5.64
|
12.24 µv
Standard Deviation 5.86
|
11.61 µv
Standard Deviation 4.56
|
12.77 µv
Standard Deviation 5.67
|
|
Single "Central" P2-component Amplitudes - Measured in Capsaicin-irritated Skin Type
at 2:00h
|
14.20 µv
Standard Deviation 5.41
|
12.09 µv
Standard Deviation 4.18
|
12.62 µv
Standard Deviation 4.10
|
12.65 µv
Standard Deviation 5.09
|
|
Single "Central" P2-component Amplitudes - Measured in Capsaicin-irritated Skin Type
at 3:00h
|
14.25 µv
Standard Deviation 5.24
|
12.97 µv
Standard Deviation 4.18
|
12.74 µv
Standard Deviation 5.02
|
11.94 µv
Standard Deviation 4.78
|
|
Single "Central" P2-component Amplitudes - Measured in Capsaicin-irritated Skin Type
at 4:00h
|
14.01 µv
Standard Deviation 6.07
|
13.20 µv
Standard Deviation 4.20
|
12.63 µv
Standard Deviation 4.74
|
11.90 µv
Standard Deviation 4.95
|
|
Single "Central" P2-component Amplitudes - Measured in Capsaicin-irritated Skin Type
at 5:00h
|
13.32 µv
Standard Deviation 5.89
|
12.79 µv
Standard Deviation 4.94
|
12.47 µv
Standard Deviation 4.63
|
11.51 µv
Standard Deviation 4.60
|
|
Single "Central" P2-component Amplitudes - Measured in Capsaicin-irritated Skin Type
at 6:00h
|
13.41 µv
Standard Deviation 5.07
|
11.87 µv
Standard Deviation 3.91
|
11.78 µv
Standard Deviation 4.76
|
11.27 µv
Standard Deviation 4.93
|
|
Single "Central" P2-component Amplitudes - Measured in Capsaicin-irritated Skin Type
at 22:00h
|
13.16 µv
Standard Deviation 5.03
|
11.62 µv
Standard Deviation 4.91
|
12.00 µv
Standard Deviation 5.00
|
11.38 µv
Standard Deviation 4.60
|
|
Single "Central" P2-component Amplitudes - Measured in Capsaicin-irritated Skin Type
at 24:00h
|
11.65 µv
Standard Deviation 3.83
|
11.24 µv
Standard Deviation 3.91
|
12.21 µv
Standard Deviation 6.54
|
11.24 µv
Standard Deviation 5.35
|
SECONDARY outcome
Timeframe: up to 24 hours(h): -2:05h, 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 22:00h, 24:00h (relative to study drug administration [h:min])Population: PDS
Electronic Visual Analogue Scale (100mm VAS "Post Laser Pain" scales) - measured in the UVB-irradiated skin type, where 0mm = 'no pain' and 100mm = 'severe pain'.
Outcome measures
| Measure |
Placebo
n=25 Participants
Matching placebo to BI 1026706, Mode of Administration: Oral with 200 mL of water.
|
50 mg BI 1026706
n=24 Participants
treatment group: 50 mg BI 1026706, powder for oral solution (PfOS), Mode of Admin.: Oral with 200 mL of water.
|
200 mg BI 1026706
n=25 Participants
treatment group: 200 mg BI 1026706, powder for oral solution (PfOS), Mode of Admin.: Oral with 200 mL of water.
|
200 mg Celecoxib (Cele)
n=25 Participants
200 mg Celecoxib (cele), hard capsule, single dose, mode of admin.: oral with 200 mL of water.
|
|---|---|---|---|---|
|
Electronic Visual Analogue Scale (VAS) (100mm VAS "Post Laser Pain" Scales) - Measured in the UVB-irradiated Skin Type
at 24:00h
|
65.00 units on a scale
Standard Deviation 24.39
|
61.96 units on a scale
Standard Deviation 26.70
|
61.13 units on a scale
Standard Deviation 27.51
|
61.96 units on a scale
Standard Deviation 27.20
|
|
Electronic Visual Analogue Scale (VAS) (100mm VAS "Post Laser Pain" Scales) - Measured in the UVB-irradiated Skin Type
at -2:05h
|
30.40 units on a scale
Standard Deviation 16.71
|
28.42 units on a scale
Standard Deviation 16.67
|
30.16 units on a scale
Standard Deviation 19.01
|
35.08 units on a scale
Standard Deviation 18.93
|
|
Electronic Visual Analogue Scale (VAS) (100mm VAS "Post Laser Pain" Scales) - Measured in the UVB-irradiated Skin Type
at 0:30h
|
39.24 units on a scale
Standard Deviation 18.16
|
32.46 units on a scale
Standard Deviation 19.71
|
32.24 units on a scale
Standard Deviation 19.60
|
38.00 units on a scale
Standard Deviation 19.56
|
|
Electronic Visual Analogue Scale (VAS) (100mm VAS "Post Laser Pain" Scales) - Measured in the UVB-irradiated Skin Type
at 1:00h
|
41.48 units on a scale
Standard Deviation 17.44
|
36.67 units on a scale
Standard Deviation 21.94
|
37.16 units on a scale
Standard Deviation 21.40
|
38.28 units on a scale
Standard Deviation 20.15
|
|
Electronic Visual Analogue Scale (VAS) (100mm VAS "Post Laser Pain" Scales) - Measured in the UVB-irradiated Skin Type
at 2:00h
|
50.56 units on a scale
Standard Deviation 22.04
|
42.92 units on a scale
Standard Deviation 23.54
|
46.88 units on a scale
Standard Deviation 21.44
|
44.00 units on a scale
Standard Deviation 19.84
|
|
Electronic Visual Analogue Scale (VAS) (100mm VAS "Post Laser Pain" Scales) - Measured in the UVB-irradiated Skin Type
at 3:00h
|
56.40 units on a scale
Standard Deviation 23.90
|
53.25 units on a scale
Standard Deviation 24.78
|
55.52 units on a scale
Standard Deviation 27.33
|
52.72 units on a scale
Standard Deviation 24.24
|
|
Electronic Visual Analogue Scale (VAS) (100mm VAS "Post Laser Pain" Scales) - Measured in the UVB-irradiated Skin Type
at 4:00h
|
62.16 units on a scale
Standard Deviation 22.96
|
56.33 units on a scale
Standard Deviation 24.64
|
62.04 units on a scale
Standard Deviation 27.73
|
56.68 units on a scale
Standard Deviation 26.64
|
|
Electronic Visual Analogue Scale (VAS) (100mm VAS "Post Laser Pain" Scales) - Measured in the UVB-irradiated Skin Type
at 5:00h
|
66.60 units on a scale
Standard Deviation 25.31
|
63.71 units on a scale
Standard Deviation 24.33
|
65.48 units on a scale
Standard Deviation 27.90
|
56.52 units on a scale
Standard Deviation 25.23
|
|
Electronic Visual Analogue Scale (VAS) (100mm VAS "Post Laser Pain" Scales) - Measured in the UVB-irradiated Skin Type
at 6:00h
|
69.24 units on a scale
Standard Deviation 23.97
|
65.46 units on a scale
Standard Deviation 25.26
|
66.60 units on a scale
Standard Deviation 27.20
|
56.48 units on a scale
Standard Deviation 25.61
|
|
Electronic Visual Analogue Scale (VAS) (100mm VAS "Post Laser Pain" Scales) - Measured in the UVB-irradiated Skin Type
at 22:00h
|
61.68 units on a scale
Standard Deviation 24.53
|
57.13 units on a scale
Standard Deviation 25.61
|
57.76 units on a scale
Standard Deviation 26.54
|
59.28 units on a scale
Standard Deviation 25.10
|
SECONDARY outcome
Timeframe: up to 24 hours(h): -1:20h, 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 22:00h, 24:00h (relative to study drug administration [h:min])Population: PDS
Electronic Visual Analogue Scale (100mm VAS "Post Laser Pain" scales) - measured in the capsaicin-irritated skin type, where 0mm = 'no pain' and 100mm = 'severe pain'.
Outcome measures
| Measure |
Placebo
n=25 Participants
Matching placebo to BI 1026706, Mode of Administration: Oral with 200 mL of water.
|
50 mg BI 1026706
n=24 Participants
treatment group: 50 mg BI 1026706, powder for oral solution (PfOS), Mode of Admin.: Oral with 200 mL of water.
|
200 mg BI 1026706
n=25 Participants
treatment group: 200 mg BI 1026706, powder for oral solution (PfOS), Mode of Admin.: Oral with 200 mL of water.
|
200 mg Celecoxib (Cele)
n=25 Participants
200 mg Celecoxib (cele), hard capsule, single dose, mode of admin.: oral with 200 mL of water.
|
|---|---|---|---|---|
|
Electronic Visual Analogue Scale (100mm VAS "Post Laser Pain" Scales) - Measured in the Capsaicin-irritated Skin Type.
at -1:20h
|
18.64 units on a scale
Standard Deviation 13.66
|
16.79 units on a scale
Standard Deviation 11.69
|
20.36 units on a scale
Standard Deviation 18.33
|
22.60 units on a scale
Standard Deviation 16.74
|
|
Electronic Visual Analogue Scale (100mm VAS "Post Laser Pain" Scales) - Measured in the Capsaicin-irritated Skin Type.
at 0:30h
|
30.64 units on a scale
Standard Deviation 17.93
|
25.96 units on a scale
Standard Deviation 16.73
|
27.92 units on a scale
Standard Deviation 19.42
|
31.28 units on a scale
Standard Deviation 18.80
|
|
Electronic Visual Analogue Scale (100mm VAS "Post Laser Pain" Scales) - Measured in the Capsaicin-irritated Skin Type.
at 22:00h
|
38.52 units on a scale
Standard Deviation 20.13
|
34.29 units on a scale
Standard Deviation 19.67
|
39.48 units on a scale
Standard Deviation 23.71
|
36.32 units on a scale
Standard Deviation 18.81
|
|
Electronic Visual Analogue Scale (100mm VAS "Post Laser Pain" Scales) - Measured in the Capsaicin-irritated Skin Type.
at 1:00h
|
35.48 units on a scale
Standard Deviation 17.70
|
30.08 units on a scale
Standard Deviation 16.68
|
33.76 units on a scale
Standard Deviation 20.68
|
32.80 units on a scale
Standard Deviation 19.65
|
|
Electronic Visual Analogue Scale (100mm VAS "Post Laser Pain" Scales) - Measured in the Capsaicin-irritated Skin Type.
at 2:00h
|
39.52 units on a scale
Standard Deviation 18.71
|
32.79 units on a scale
Standard Deviation 19.76
|
36.92 units on a scale
Standard Deviation 21.38
|
32.16 units on a scale
Standard Deviation 17.27
|
|
Electronic Visual Analogue Scale (100mm VAS "Post Laser Pain" Scales) - Measured in the Capsaicin-irritated Skin Type.
at 3:00h
|
46.44 units on a scale
Standard Deviation 20.02
|
38.79 units on a scale
Standard Deviation 20.03
|
44.52 units on a scale
Standard Deviation 26.01
|
37.16 units on a scale
Standard Deviation 18.68
|
|
Electronic Visual Analogue Scale (100mm VAS "Post Laser Pain" Scales) - Measured in the Capsaicin-irritated Skin Type.
at 4:00h
|
47.48 units on a scale
Standard Deviation 21.92
|
41.79 units on a scale
Standard Deviation 19.14
|
48.40 units on a scale
Standard Deviation 26.97
|
40.92 units on a scale
Standard Deviation 20.25
|
|
Electronic Visual Analogue Scale (100mm VAS "Post Laser Pain" Scales) - Measured in the Capsaicin-irritated Skin Type.
at 5:00h
|
49.16 units on a scale
Standard Deviation 21.51
|
44.29 units on a scale
Standard Deviation 19.78
|
47.56 units on a scale
Standard Deviation 26.15
|
43.92 units on a scale
Standard Deviation 21.63
|
|
Electronic Visual Analogue Scale (100mm VAS "Post Laser Pain" Scales) - Measured in the Capsaicin-irritated Skin Type.
at 6:00h
|
50.48 units on a scale
Standard Deviation 24.91
|
47.21 units on a scale
Standard Deviation 20.84
|
47.00 units on a scale
Standard Deviation 25.03
|
41.56 units on a scale
Standard Deviation 20.64
|
|
Electronic Visual Analogue Scale (100mm VAS "Post Laser Pain" Scales) - Measured in the Capsaicin-irritated Skin Type.
at 24:00h
|
39.92 units on a scale
Standard Deviation 19.96
|
36.83 units on a scale
Standard Deviation 20.12
|
38.60 units on a scale
Standard Deviation 22.70
|
37.80 units on a scale
Standard Deviation 18.65
|
SECONDARY outcome
Timeframe: up to 24 hours(h): -1:20h, 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 22:00h, 24:00h (relative to study drug administration [h:min])Population: PDS
Weighted needle (pain) threshold (WNT) in the secondary flare area of capsaicin-irritated skin. The weighted needle (pain) threshold (WNT) will be determined (with regard to investigation of mechanical hyperalgesia in the secondary hyperalgesia zone around the primary capsaicin application zone) by fixed weight steps - contact made by "rounded" needle tip to skin (ranging from 1 mN to 512 mN).
Outcome measures
| Measure |
Placebo
n=25 Participants
Matching placebo to BI 1026706, Mode of Administration: Oral with 200 mL of water.
|
50 mg BI 1026706
n=24 Participants
treatment group: 50 mg BI 1026706, powder for oral solution (PfOS), Mode of Admin.: Oral with 200 mL of water.
|
200 mg BI 1026706
n=25 Participants
treatment group: 200 mg BI 1026706, powder for oral solution (PfOS), Mode of Admin.: Oral with 200 mL of water.
|
200 mg Celecoxib (Cele)
n=25 Participants
200 mg Celecoxib (cele), hard capsule, single dose, mode of admin.: oral with 200 mL of water.
|
|---|---|---|---|---|
|
Weighted Needle (Pain) Threshold (WNT) in the Secondary Flare Area of Capsaicin-irritated Skin
at -1:20h
|
348.72 millinewton (mN)
Standard Deviation 131.75
|
366.65 millinewton (mN)
Standard Deviation 123.95
|
369.98 millinewton (mN)
Standard Deviation 142.20
|
347.12 millinewton (mN)
Standard Deviation 133.57
|
|
Weighted Needle (Pain) Threshold (WNT) in the Secondary Flare Area of Capsaicin-irritated Skin
at 0:30h
|
312.88 millinewton (mN)
Standard Deviation 137.29
|
295.65 millinewton (mN)
Standard Deviation 126.48
|
285.78 millinewton (mN)
Standard Deviation 122.17
|
301.48 millinewton (mN)
Standard Deviation 157.97
|
|
Weighted Needle (Pain) Threshold (WNT) in the Secondary Flare Area of Capsaicin-irritated Skin
at 1:00h
|
290.28 millinewton (mN)
Standard Deviation 144.08
|
285.35 millinewton (mN)
Standard Deviation 144.26
|
262.20 millinewton (mN)
Standard Deviation 117.10
|
280.38 millinewton (mN)
Standard Deviation 160.61
|
|
Weighted Needle (Pain) Threshold (WNT) in the Secondary Flare Area of Capsaicin-irritated Skin
at 2:00h
|
269.70 millinewton (mN)
Standard Deviation 139.49
|
287.94 millinewton (mN)
Standard Deviation 148.70
|
225.48 millinewton (mN)
Standard Deviation 112.11
|
254.70 millinewton (mN)
Standard Deviation 150.10
|
|
Weighted Needle (Pain) Threshold (WNT) in the Secondary Flare Area of Capsaicin-irritated Skin
at 3:00h
|
274.30 millinewton (mN)
Standard Deviation 148.21
|
265.58 millinewton (mN)
Standard Deviation 147.81
|
222.66 millinewton (mN)
Standard Deviation 119.98
|
265.51 millinewton (mN)
Standard Deviation 145.58
|
|
Weighted Needle (Pain) Threshold (WNT) in the Secondary Flare Area of Capsaicin-irritated Skin
at 4:00h
|
268.38 millinewton (mN)
Standard Deviation 148.57
|
265.77 millinewton (mN)
Standard Deviation 151.62
|
235.15 millinewton (mN)
Standard Deviation 114.60
|
255.45 millinewton (mN)
Standard Deviation 140.19
|
|
Weighted Needle (Pain) Threshold (WNT) in the Secondary Flare Area of Capsaicin-irritated Skin
at 5:00h
|
261.50 millinewton (mN)
Standard Deviation 140.44
|
270.27 millinewton (mN)
Standard Deviation 157.88
|
228.09 millinewton (mN)
Standard Deviation 122.48
|
266.83 millinewton (mN)
Standard Deviation 141.25
|
|
Weighted Needle (Pain) Threshold (WNT) in the Secondary Flare Area of Capsaicin-irritated Skin
at 6:00h
|
292.30 millinewton (mN)
Standard Deviation 158.11
|
281.21 millinewton (mN)
Standard Deviation 163.78
|
234.30 millinewton (mN)
Standard Deviation 124.55
|
273.42 millinewton (mN)
Standard Deviation 125.06
|
|
Weighted Needle (Pain) Threshold (WNT) in the Secondary Flare Area of Capsaicin-irritated Skin
at 22:00h
|
331.76 millinewton (mN)
Standard Deviation 152.45
|
313.77 millinewton (mN)
Standard Deviation 159.07
|
274.92 millinewton (mN)
Standard Deviation 125.73
|
330.26 millinewton (mN)
Standard Deviation 147.94
|
|
Weighted Needle (Pain) Threshold (WNT) in the Secondary Flare Area of Capsaicin-irritated Skin
at 24:00h
|
323.38 millinewton (mN)
Standard Deviation 138.05
|
312.85 millinewton (mN)
Standard Deviation 156.45
|
277.38 millinewton (mN)
Standard Deviation 148.59
|
340.76 millinewton (mN)
Standard Deviation 147.36
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
50 mg BI 1026706
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
200 mg BI 1026706
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
200 mg Celecoxib
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
150 mg Pregabalin
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=25 participants at risk
Matching placebo to BI 1026706, Mode of Administration: Oral with 200 mL of water.
|
50 mg BI 1026706
n=24 participants at risk
treatment group: 50 mg BI 1026706
|
200 mg BI 1026706
n=25 participants at risk
treatment group: 200 BI 1026706
|
200 mg Celecoxib
n=25 participants at risk
treatment group: 200 mg celecoxib
|
150 mg Pregabalin
n=25 participants at risk
treatment group: 150 mg pregabalin
|
|---|---|---|---|---|---|
|
Cardiac disorders
Sinus bradycardia
|
12.0%
3/25 • From the start day of trial medication administration to Day 3 ( 3 days after the last trial medication)
|
8.3%
2/24 • From the start day of trial medication administration to Day 3 ( 3 days after the last trial medication)
|
12.0%
3/25 • From the start day of trial medication administration to Day 3 ( 3 days after the last trial medication)
|
8.0%
2/25 • From the start day of trial medication administration to Day 3 ( 3 days after the last trial medication)
|
20.0%
5/25 • From the start day of trial medication administration to Day 3 ( 3 days after the last trial medication)
|
|
General disorders
Fatigue
|
0.00%
0/25 • From the start day of trial medication administration to Day 3 ( 3 days after the last trial medication)
|
0.00%
0/24 • From the start day of trial medication administration to Day 3 ( 3 days after the last trial medication)
|
0.00%
0/25 • From the start day of trial medication administration to Day 3 ( 3 days after the last trial medication)
|
0.00%
0/25 • From the start day of trial medication administration to Day 3 ( 3 days after the last trial medication)
|
32.0%
8/25 • From the start day of trial medication administration to Day 3 ( 3 days after the last trial medication)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/25 • From the start day of trial medication administration to Day 3 ( 3 days after the last trial medication)
|
0.00%
0/24 • From the start day of trial medication administration to Day 3 ( 3 days after the last trial medication)
|
0.00%
0/25 • From the start day of trial medication administration to Day 3 ( 3 days after the last trial medication)
|
0.00%
0/25 • From the start day of trial medication administration to Day 3 ( 3 days after the last trial medication)
|
36.0%
9/25 • From the start day of trial medication administration to Day 3 ( 3 days after the last trial medication)
|
|
Nervous system disorders
Headache
|
0.00%
0/25 • From the start day of trial medication administration to Day 3 ( 3 days after the last trial medication)
|
0.00%
0/24 • From the start day of trial medication administration to Day 3 ( 3 days after the last trial medication)
|
0.00%
0/25 • From the start day of trial medication administration to Day 3 ( 3 days after the last trial medication)
|
0.00%
0/25 • From the start day of trial medication administration to Day 3 ( 3 days after the last trial medication)
|
8.0%
2/25 • From the start day of trial medication administration to Day 3 ( 3 days after the last trial medication)
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim pharmaceuticals
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER