Healthy
Conditions
Brief summary
* To investigate the influence of different doses of BI 1026706 on the primary endpoint (PtP-amplitude LEP in UV skin) compared to placebo. * The comparison of both doses of BI 1026706 to celecoxib in the UVB treatment. * Comparison of both doses of BI 1026706 to placebo and pregabalin in the capsaicin treatment * Exploration of the pharmacokinetics of BI 1026706 * Exploration of safety and tolerability of BI 1026706
Interventions
Placebo tablet
DRUGPregabalin
Pregabalin hard capsule
DRUGBI 1026706
BI 1026706 oral solution
DRUGCelecoxib
Celecoxib hard capsule
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy males according to the investigator's assessment, as based on the following criteria: a complete medical history including a physical examination, vital signs (Blood Pressure, Pulse Rate), 12-lead electrocardiogram, and clinical laboratory 2. Age 18 to 55 years (incl.) 3. BMI (Body Mass Index) 18.5 to 29.9 kg/m2 (incl.) 4. Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation
Exclusion criteria
1. Any finding in the medical examination (including Blood Pressure, Pulse Rate or Electrocardiogram) deviating from normal and judged clinically relevant by the investigator 2. Repeated measurement of systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg 3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance 4. Any evidence of a concomitant disease judged clinically relevant by the investigator 5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders 6. Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug(s) 7. Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Peak-to-Peak(PtP) N2/P2-component Amplitude of Laser (Somatosensory/Radiant Heat) Evoked Potentials (LEP) in Ultraviolet B (UVB) -Irradiated Skin | 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]) | Overall Peak-to-Peak (PtP) N2/P2-component amplitude of Laser (somatosensory/radiant heat) evoked potentials (LEP) in UVB-irradiated skin. Treated set (TS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Single Peripheral N2-component Amplitudes - Measured in UVB-irradiated Skin Type | 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]) | Single peripheral N2-component amplitudes - measured in UVB-irradiated skin type. |
| Single Peripheral N2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | 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]) | Single peripheral N2-component amplitudes - measured in capsaicin-irritated skin type. |
| Single Central P2-component Amplitudes - Measured in UVB-irradiated Skin Type | 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]) | Single central P2-component amplitudes - measured in UVB-irradiated skin type. |
| Overall Peak-to-Peak (PtP) N2/P2-component Amplitude of (LEP) in Capsaicin-irritated Skin | 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]) | Overall Peak-to-Peak (PtP) N2/P2-component amplitude of (LEP) in capsaicin-irritated skin. |
| Electronic Visual Analogue Scale (VAS) (100mm VAS Post Laser Pain Scales) - Measured in the UVB-irradiated Skin Type | 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]) | 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'. |
| Electronic Visual Analogue Scale (100mm VAS Post Laser Pain Scales) - Measured in the Capsaicin-irritated Skin Type. | 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]) | 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'. |
| Weighted Needle (Pain) Threshold (WNT) in the Secondary Flare Area of Capsaicin-irritated Skin | 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]) | 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). |
| Single Central P2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | 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]) | Single central P2-component amplitudes - measured in capsaicin-irritated skin type. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 (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. | 5 |
| 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. | 5 |
| 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. | 5 |
| 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. | 5 |
| 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 (hard capsule), placebo (matching placebo), 50mg BI 1026706 (PfOS). Mode of admin.: oral with 200 mL of water. | 5 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Washout Period 4 (6 Days) | Withdrawal by Subject | 0 | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | 50mg BI1026706/ 200mg BI1026706/Placebo/200mg Cele/150mg Preg | 200mg BI1026706/50mg BI1026706/200mg Cele/150mg Preg/Placebo | Placebo/150mg Preg/50mg BI1026706/200mg BI1026706/200mg Cele | 200mg Cele/Placebo/150mg Preg/50mg BI1026706/200mg BI1026706 | 150mg Preg/200mg Cele/200mg BI1026706/Placebo/50mg BI1026706 | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 31.2 years STANDARD_DEVIATION 10.3 | 35.8 years STANDARD_DEVIATION 11.6 | 41.2 years STANDARD_DEVIATION 10.9 | 35.0 years STANDARD_DEVIATION 11.2 | 32.8 years STANDARD_DEVIATION 7.9 | 35.2 years STANDARD_DEVIATION 10.2 |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 5 Participants | 5 Participants | 5 Participants | 5 Participants | 5 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 3 / 25 | 2 / 24 | 3 / 25 | 2 / 25 | 17 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 24 | 0 / 25 | 0 / 25 | 0 / 25 |
Outcome results
Primary
Overall Peak-to-Peak(PtP) N2/P2-component Amplitude of Laser (Somatosensory/Radiant Heat) Evoked Potentials (LEP) in Ultraviolet B (UVB) -Irradiated Skin
Overall Peak-to-Peak (PtP) N2/P2-component amplitude of Laser (somatosensory/radiant heat) evoked potentials (LEP) in UVB-irradiated skin. Treated set (TS)
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 9.5 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| 50 mg BI 1026706 | 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 | 27.11 Microvolts (µv) | Standard Deviation 8.64 |
| 50 mg BI 1026706 | 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 | 32.51 Microvolts (µv) | Standard Deviation 8.3 |
| 50 mg BI 1026706 | 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 | 28.78 Microvolts (µv) | Standard Deviation 8.81 |
| 50 mg BI 1026706 | 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 | 30.93 Microvolts (µv) | Standard Deviation 7.39 |
| 50 mg BI 1026706 | 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 | 31.40 Microvolts (µv) | Standard Deviation 10.9 |
| 50 mg BI 1026706 | 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 | 30.10 Microvolts (µv) | Standard Deviation 8.37 |
| 50 mg BI 1026706 | 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 | 32.83 Microvolts (µv) | Standard Deviation 9.62 |
| 50 mg BI 1026706 | 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 | 28.12 Microvolts (µv) | Standard Deviation 8.29 |
| 50 mg BI 1026706 | 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 | 26.08 Microvolts (µv) | Standard Deviation 10.41 |
| 50 mg BI 1026706 | 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 | 28.00 Microvolts (µv) | Standard Deviation 10.67 |
| 200 mg BI 1026706 | 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 | 29.04 Microvolts (µv) | Standard Deviation 10.66 |
| 200 mg BI 1026706 | 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 | 30.79 Microvolts (µv) | Standard Deviation 9.84 |
| 200 mg BI 1026706 | 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 | 32.98 Microvolts (µv) | Standard Deviation 12.31 |
| 200 mg BI 1026706 | 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 | 28.93 Microvolts (µv) | Standard Deviation 8.06 |
| 200 mg BI 1026706 | 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 | 29.03 Microvolts (µv) | Standard Deviation 9.04 |
| 200 mg BI 1026706 | 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 | 31.44 Microvolts (µv) | Standard Deviation 8.42 |
| 200 mg BI 1026706 | 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 | 34.50 Microvolts (µv) | Standard Deviation 10.97 |
| 200 mg BI 1026706 | 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 | 24.88 Microvolts (µv) | Standard Deviation 8.69 |
| 200 mg BI 1026706 | 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 | 29.02 Microvolts (µv) | Standard Deviation 7.98 |
| 200 mg BI 1026706 | 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 | 26.77 Microvolts (µv) | Standard Deviation 10.31 |
| 200 mg Celecoxib (Cele) | 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 | 25.05 Microvolts (µv) | Standard Deviation 8.32 |
| 200 mg Celecoxib (Cele) | 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 | 26.77 Microvolts (µv) | Standard Deviation 8.61 |
| 200 mg Celecoxib (Cele) | 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 | 23.97 Microvolts (µv) | Standard Deviation 7.71 |
| 200 mg Celecoxib (Cele) | 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 | 30.03 Microvolts (µv) | Standard Deviation 10.54 |
| 200 mg Celecoxib (Cele) | 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 | 24.10 Microvolts (µv) | Standard Deviation 8.78 |
| 200 mg Celecoxib (Cele) | 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 | 26.60 Microvolts (µv) | Standard Deviation 8.9 |
| 200 mg Celecoxib (Cele) | 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 | 27.60 Microvolts (µv) | Standard Deviation 9.31 |
| 200 mg Celecoxib (Cele) | 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 | 24.87 Microvolts (µv) | Standard Deviation 7.11 |
| 200 mg Celecoxib (Cele) | 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 | 26.35 Microvolts (µv) | Standard Deviation 9.22 |
| 200 mg Celecoxib (Cele) | 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 | 33.06 Microvolts (µv) | Standard Deviation 11.33 |
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-3, 5.2]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-1.4, 6.8]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-1.1, 7.1]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-1.6, 6.6]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-2.4, 5.8]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-4.2, 3.9]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-7.2, 0.9]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-5.4, 2.8]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-4.2, 3.9]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-6.7, 1.3]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-2.4, 5.6]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-1.4, 6.6]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-4.2, 3.8]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-2.8, 5.2]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-4.6, 3.4]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-6.9, 1.1]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-3.6, 4.4]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-5, 2.9]
Secondary
Electronic Visual Analogue Scale (100mm VAS Post Laser Pain Scales) - Measured in the Capsaicin-irritated Skin Type.
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'.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 17.7 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| 50 mg BI 1026706 | Electronic Visual Analogue Scale (100mm VAS Post Laser Pain Scales) - Measured in the Capsaicin-irritated Skin Type. | at 1:00h | 30.08 units on a scale | Standard Deviation 16.68 |
| 50 mg BI 1026706 | Electronic Visual Analogue Scale (100mm VAS Post Laser Pain Scales) - Measured in the Capsaicin-irritated Skin Type. | at 22:00h | 34.29 units on a scale | Standard Deviation 19.67 |
| 50 mg BI 1026706 | Electronic Visual Analogue Scale (100mm VAS Post Laser Pain Scales) - Measured in the Capsaicin-irritated Skin Type. | at 2:00h | 32.79 units on a scale | Standard Deviation 19.76 |
| 50 mg BI 1026706 | Electronic Visual Analogue Scale (100mm VAS Post Laser Pain Scales) - Measured in the Capsaicin-irritated Skin Type. | at 3:00h | 38.79 units on a scale | Standard Deviation 20.03 |
| 50 mg BI 1026706 | Electronic Visual Analogue Scale (100mm VAS Post Laser Pain Scales) - Measured in the Capsaicin-irritated Skin Type. | at 4:00h | 41.79 units on a scale | Standard Deviation 19.14 |
| 50 mg BI 1026706 | Electronic Visual Analogue Scale (100mm VAS Post Laser Pain Scales) - Measured in the Capsaicin-irritated Skin Type. | at 5:00h | 44.29 units on a scale | Standard Deviation 19.78 |
| 50 mg BI 1026706 | Electronic Visual Analogue Scale (100mm VAS Post Laser Pain Scales) - Measured in the Capsaicin-irritated Skin Type. | at 24:00h | 36.83 units on a scale | Standard Deviation 20.12 |
| 50 mg BI 1026706 | Electronic Visual Analogue Scale (100mm VAS Post Laser Pain Scales) - Measured in the Capsaicin-irritated Skin Type. | at 6:00h | 47.21 units on a scale | Standard Deviation 20.84 |
| 50 mg BI 1026706 | Electronic Visual Analogue Scale (100mm VAS Post Laser Pain Scales) - Measured in the Capsaicin-irritated Skin Type. | at -1:20h | 16.79 units on a scale | Standard Deviation 11.69 |
| 50 mg BI 1026706 | Electronic Visual Analogue Scale (100mm VAS Post Laser Pain Scales) - Measured in the Capsaicin-irritated Skin Type. | at 0:30h | 25.96 units on a scale | Standard Deviation 16.73 |
| 200 mg BI 1026706 | Electronic Visual Analogue Scale (100mm VAS Post Laser Pain Scales) - Measured in the Capsaicin-irritated Skin Type. | at 6:00h | 47.00 units on a scale | Standard Deviation 25.03 |
| 200 mg BI 1026706 | Electronic Visual Analogue Scale (100mm VAS Post Laser Pain Scales) - Measured in the Capsaicin-irritated Skin Type. | at 5:00h | 47.56 units on a scale | Standard Deviation 26.15 |
| 200 mg BI 1026706 | Electronic Visual Analogue Scale (100mm VAS Post Laser Pain Scales) - Measured in the Capsaicin-irritated Skin Type. | at 24:00h | 38.60 units on a scale | Standard Deviation 22.7 |
| 200 mg BI 1026706 | Electronic Visual Analogue Scale (100mm VAS Post Laser Pain Scales) - Measured in the Capsaicin-irritated Skin Type. | at -1:20h | 20.36 units on a scale | Standard Deviation 18.33 |
| 200 mg BI 1026706 | Electronic Visual Analogue Scale (100mm VAS Post Laser Pain Scales) - Measured in the Capsaicin-irritated Skin Type. | at 2:00h | 36.92 units on a scale | Standard Deviation 21.38 |
| 200 mg BI 1026706 | Electronic Visual Analogue Scale (100mm VAS Post Laser Pain Scales) - Measured in the Capsaicin-irritated Skin Type. | at 4:00h | 48.40 units on a scale | Standard Deviation 26.97 |
| 200 mg BI 1026706 | Electronic Visual Analogue Scale (100mm VAS Post Laser Pain Scales) - Measured in the Capsaicin-irritated Skin Type. | at 22:00h | 39.48 units on a scale | Standard Deviation 23.71 |
| 200 mg BI 1026706 | Electronic Visual Analogue Scale (100mm VAS Post Laser Pain Scales) - Measured in the Capsaicin-irritated Skin Type. | at 0:30h | 27.92 units on a scale | Standard Deviation 19.42 |
| 200 mg BI 1026706 | Electronic Visual Analogue Scale (100mm VAS Post Laser Pain Scales) - Measured in the Capsaicin-irritated Skin Type. | at 3:00h | 44.52 units on a scale | Standard Deviation 26.01 |
| 200 mg BI 1026706 | Electronic Visual Analogue Scale (100mm VAS Post Laser Pain Scales) - Measured in the Capsaicin-irritated Skin Type. | at 1:00h | 33.76 units on a scale | Standard Deviation 20.68 |
| 200 mg Celecoxib (Cele) | Electronic Visual Analogue Scale (100mm VAS Post Laser Pain Scales) - Measured in the Capsaicin-irritated Skin Type. | at 3:00h | 37.16 units on a scale | Standard Deviation 18.68 |
| 200 mg Celecoxib (Cele) | Electronic Visual Analogue Scale (100mm VAS Post Laser Pain Scales) - Measured in the Capsaicin-irritated Skin Type. | at 6:00h | 41.56 units on a scale | Standard Deviation 20.64 |
| 200 mg Celecoxib (Cele) | Electronic Visual Analogue Scale (100mm VAS Post Laser Pain Scales) - Measured in the Capsaicin-irritated Skin Type. | at 4:00h | 40.92 units on a scale | Standard Deviation 20.25 |
| 200 mg Celecoxib (Cele) | Electronic Visual Analogue Scale (100mm VAS Post Laser Pain Scales) - Measured in the Capsaicin-irritated Skin Type. | at 24:00h | 37.80 units on a scale | Standard Deviation 18.65 |
| 200 mg Celecoxib (Cele) | Electronic Visual Analogue Scale (100mm VAS Post Laser Pain Scales) - Measured in the Capsaicin-irritated Skin Type. | at 5:00h | 43.92 units on a scale | Standard Deviation 21.63 |
| 200 mg Celecoxib (Cele) | Electronic Visual Analogue Scale (100mm VAS Post Laser Pain Scales) - Measured in the Capsaicin-irritated Skin Type. | at 0:30h | 31.28 units on a scale | Standard Deviation 18.8 |
| 200 mg Celecoxib (Cele) | Electronic Visual Analogue Scale (100mm VAS Post Laser Pain Scales) - Measured in the Capsaicin-irritated Skin Type. | at 1:00h | 32.80 units on a scale | Standard Deviation 19.65 |
| 200 mg Celecoxib (Cele) | Electronic Visual Analogue Scale (100mm VAS Post Laser Pain Scales) - Measured in the Capsaicin-irritated Skin Type. | at 2:00h | 32.16 units on a scale | Standard Deviation 17.27 |
| 200 mg Celecoxib (Cele) | Electronic Visual Analogue Scale (100mm VAS Post Laser Pain Scales) - Measured in the Capsaicin-irritated Skin Type. | at -1:20h | 22.60 units on a scale | Standard Deviation 16.74 |
| 200 mg Celecoxib (Cele) | Electronic Visual Analogue Scale (100mm VAS Post Laser Pain Scales) - Measured in the Capsaicin-irritated Skin Type. | at 22:00h | 36.32 units on a scale | Standard Deviation 18.81 |
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-8.9, 1.3]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-9.8, 0.3]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-11.9, -0.3]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-13.8, 0.1]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-12.6, 2.1]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-11.9, 2.5]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-10.5, 4.3]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-12.1, 4.5]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-9.5, 4.1]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-8.7, 1.4]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-7.4, 2.5]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-9, 2.5]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-9.8, 4]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-7, 7.5]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-9.4, 4.8]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-11.5, 3.1]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-7.7, 8.8]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-8.8, 4.7]
Secondary
Electronic Visual Analogue Scale (VAS) (100mm VAS Post Laser Pain Scales) - Measured in the UVB-irradiated Skin Type
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'.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 23.9 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| 50 mg BI 1026706 | Electronic Visual Analogue Scale (VAS) (100mm VAS Post Laser Pain Scales) - Measured in the UVB-irradiated Skin Type | at 1:00h | 36.67 units on a scale | Standard Deviation 21.94 |
| 50 mg BI 1026706 | Electronic Visual Analogue Scale (VAS) (100mm VAS Post Laser Pain Scales) - Measured in the UVB-irradiated Skin Type | at 22:00h | 57.13 units on a scale | Standard Deviation 25.61 |
| 50 mg BI 1026706 | Electronic Visual Analogue Scale (VAS) (100mm VAS Post Laser Pain Scales) - Measured in the UVB-irradiated Skin Type | at 2:00h | 42.92 units on a scale | Standard Deviation 23.54 |
| 50 mg BI 1026706 | Electronic Visual Analogue Scale (VAS) (100mm VAS Post Laser Pain Scales) - Measured in the UVB-irradiated Skin Type | at 3:00h | 53.25 units on a scale | Standard Deviation 24.78 |
| 50 mg BI 1026706 | Electronic Visual Analogue Scale (VAS) (100mm VAS Post Laser Pain Scales) - Measured in the UVB-irradiated Skin Type | at 4:00h | 56.33 units on a scale | Standard Deviation 24.64 |
| 50 mg BI 1026706 | Electronic Visual Analogue Scale (VAS) (100mm VAS Post Laser Pain Scales) - Measured in the UVB-irradiated Skin Type | at 5:00h | 63.71 units on a scale | Standard Deviation 24.33 |
| 50 mg BI 1026706 | Electronic Visual Analogue Scale (VAS) (100mm VAS Post Laser Pain Scales) - Measured in the UVB-irradiated Skin Type | at 24:00h | 61.96 units on a scale | Standard Deviation 26.7 |
| 50 mg BI 1026706 | Electronic Visual Analogue Scale (VAS) (100mm VAS Post Laser Pain Scales) - Measured in the UVB-irradiated Skin Type | at 6:00h | 65.46 units on a scale | Standard Deviation 25.26 |
| 50 mg BI 1026706 | Electronic Visual Analogue Scale (VAS) (100mm VAS Post Laser Pain Scales) - Measured in the UVB-irradiated Skin Type | at -2:05h | 28.42 units on a scale | Standard Deviation 16.67 |
| 50 mg BI 1026706 | Electronic Visual Analogue Scale (VAS) (100mm VAS Post Laser Pain Scales) - Measured in the UVB-irradiated Skin Type | at 0:30h | 32.46 units on a scale | Standard Deviation 19.71 |
| 200 mg BI 1026706 | Electronic Visual Analogue Scale (VAS) (100mm VAS Post Laser Pain Scales) - Measured in the UVB-irradiated Skin Type | at 6:00h | 66.60 units on a scale | Standard Deviation 27.2 |
| 200 mg BI 1026706 | Electronic Visual Analogue Scale (VAS) (100mm VAS Post Laser Pain Scales) - Measured in the UVB-irradiated Skin Type | at 5:00h | 65.48 units on a scale | Standard Deviation 27.9 |
| 200 mg BI 1026706 | Electronic Visual Analogue Scale (VAS) (100mm VAS Post Laser Pain Scales) - Measured in the UVB-irradiated Skin Type | at 24:00h | 61.13 units on a scale | Standard Deviation 27.51 |
| 200 mg BI 1026706 | Electronic Visual Analogue Scale (VAS) (100mm VAS Post Laser Pain Scales) - Measured in the UVB-irradiated Skin Type | at -2:05h | 30.16 units on a scale | Standard Deviation 19.01 |
| 200 mg BI 1026706 | Electronic Visual Analogue Scale (VAS) (100mm VAS Post Laser Pain Scales) - Measured in the UVB-irradiated Skin Type | at 2:00h | 46.88 units on a scale | Standard Deviation 21.44 |
| 200 mg BI 1026706 | Electronic Visual Analogue Scale (VAS) (100mm VAS Post Laser Pain Scales) - Measured in the UVB-irradiated Skin Type | at 4:00h | 62.04 units on a scale | Standard Deviation 27.73 |
| 200 mg BI 1026706 | Electronic Visual Analogue Scale (VAS) (100mm VAS Post Laser Pain Scales) - Measured in the UVB-irradiated Skin Type | at 22:00h | 57.76 units on a scale | Standard Deviation 26.54 |
| 200 mg BI 1026706 | Electronic Visual Analogue Scale (VAS) (100mm VAS Post Laser Pain Scales) - Measured in the UVB-irradiated Skin Type | at 0:30h | 32.24 units on a scale | Standard Deviation 19.6 |
| 200 mg BI 1026706 | Electronic Visual Analogue Scale (VAS) (100mm VAS Post Laser Pain Scales) - Measured in the UVB-irradiated Skin Type | at 3:00h | 55.52 units on a scale | Standard Deviation 27.33 |
| 200 mg BI 1026706 | Electronic Visual Analogue Scale (VAS) (100mm VAS Post Laser Pain Scales) - Measured in the UVB-irradiated Skin Type | at 1:00h | 37.16 units on a scale | Standard Deviation 21.4 |
| 200 mg Celecoxib (Cele) | Electronic Visual Analogue Scale (VAS) (100mm VAS Post Laser Pain Scales) - Measured in the UVB-irradiated Skin Type | at 3:00h | 52.72 units on a scale | Standard Deviation 24.24 |
| 200 mg Celecoxib (Cele) | Electronic Visual Analogue Scale (VAS) (100mm VAS Post Laser Pain Scales) - Measured in the UVB-irradiated Skin Type | at 6:00h | 56.48 units on a scale | Standard Deviation 25.61 |
| 200 mg Celecoxib (Cele) | Electronic Visual Analogue Scale (VAS) (100mm VAS Post Laser Pain Scales) - Measured in the UVB-irradiated Skin Type | at 4:00h | 56.68 units on a scale | Standard Deviation 26.64 |
| 200 mg Celecoxib (Cele) | Electronic Visual Analogue Scale (VAS) (100mm VAS Post Laser Pain Scales) - Measured in the UVB-irradiated Skin Type | at 24:00h | 61.96 units on a scale | Standard Deviation 27.2 |
| 200 mg Celecoxib (Cele) | Electronic Visual Analogue Scale (VAS) (100mm VAS Post Laser Pain Scales) - Measured in the UVB-irradiated Skin Type | at 5:00h | 56.52 units on a scale | Standard Deviation 25.23 |
| 200 mg Celecoxib (Cele) | Electronic Visual Analogue Scale (VAS) (100mm VAS Post Laser Pain Scales) - Measured in the UVB-irradiated Skin Type | at 0:30h | 38.00 units on a scale | Standard Deviation 19.56 |
| 200 mg Celecoxib (Cele) | Electronic Visual Analogue Scale (VAS) (100mm VAS Post Laser Pain Scales) - Measured in the UVB-irradiated Skin Type | at 1:00h | 38.28 units on a scale | Standard Deviation 20.15 |
| 200 mg Celecoxib (Cele) | Electronic Visual Analogue Scale (VAS) (100mm VAS Post Laser Pain Scales) - Measured in the UVB-irradiated Skin Type | at 2:00h | 44.00 units on a scale | Standard Deviation 19.84 |
| 200 mg Celecoxib (Cele) | Electronic Visual Analogue Scale (VAS) (100mm VAS Post Laser Pain Scales) - Measured in the UVB-irradiated Skin Type | at -2:05h | 35.08 units on a scale | Standard Deviation 18.93 |
| 200 mg Celecoxib (Cele) | Electronic Visual Analogue Scale (VAS) (100mm VAS Post Laser Pain Scales) - Measured in the UVB-irradiated Skin Type | at 22:00h | 59.28 units on a scale | Standard Deviation 25.1 |
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-12.5, 0.2]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-10.6, 2.9]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-13.3, 0]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-8.9, 5.3]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-10.7, 1.8]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-6.4, 4]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-8.7, 4]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-10.3, 4.7]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-7, 4.4]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-13.2, -0.07]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-10.9, 2.4]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-10.1, 2.9]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-7.8, 6.2]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-6.2, 6.1]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-6.1, 4]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-8.8, 3.7]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-11.2, 3.5]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-8.7, 2.6]
Secondary
Overall Peak-to-Peak (PtP) N2/P2-component Amplitude of (LEP) in Capsaicin-irritated Skin
Overall Peak-to-Peak (PtP) N2/P2-component amplitude of (LEP) in capsaicin-irritated skin.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | Overall Peak-to-Peak (PtP) N2/P2-component Amplitude of (LEP) in Capsaicin-irritated Skin | at 6:00h | 25.77 µv | Standard Deviation 9.1 |
| Placebo | Overall Peak-to-Peak (PtP) N2/P2-component Amplitude of (LEP) in Capsaicin-irritated Skin | at 22:00h | 26.75 µv | Standard Deviation 9 |
| Placebo | 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 |
| 50 mg BI 1026706 | Overall Peak-to-Peak (PtP) N2/P2-component Amplitude of (LEP) in Capsaicin-irritated Skin | at 1:00h | 23.67 µv | Standard Deviation 10.49 |
| 50 mg BI 1026706 | Overall Peak-to-Peak (PtP) N2/P2-component Amplitude of (LEP) in Capsaicin-irritated Skin | at 22:00h | 24.46 µv | Standard Deviation 9.07 |
| 50 mg BI 1026706 | Overall Peak-to-Peak (PtP) N2/P2-component Amplitude of (LEP) in Capsaicin-irritated Skin | at 2:00h | 23.94 µv | Standard Deviation 8.4 |
| 50 mg BI 1026706 | Overall Peak-to-Peak (PtP) N2/P2-component Amplitude of (LEP) in Capsaicin-irritated Skin | at 3:00h | 25.68 µv | Standard Deviation 8.2 |
| 50 mg BI 1026706 | Overall Peak-to-Peak (PtP) N2/P2-component Amplitude of (LEP) in Capsaicin-irritated Skin | at 4:00h | 26.74 µv | Standard Deviation 6.99 |
| 50 mg BI 1026706 | Overall Peak-to-Peak (PtP) N2/P2-component Amplitude of (LEP) in Capsaicin-irritated Skin | at 5:00h | 25.81 µv | Standard Deviation 9.44 |
| 50 mg BI 1026706 | Overall Peak-to-Peak (PtP) N2/P2-component Amplitude of (LEP) in Capsaicin-irritated Skin | at 24:00h | 22.94 µv | Standard Deviation 8.06 |
| 50 mg BI 1026706 | Overall Peak-to-Peak (PtP) N2/P2-component Amplitude of (LEP) in Capsaicin-irritated Skin | at 6:00h | 24.14 µv | Standard Deviation 8.33 |
| 50 mg BI 1026706 | Overall Peak-to-Peak (PtP) N2/P2-component Amplitude of (LEP) in Capsaicin-irritated Skin | at -1:20h | 18.53 µv | Standard Deviation 6.88 |
| 50 mg BI 1026706 | Overall Peak-to-Peak (PtP) N2/P2-component Amplitude of (LEP) in Capsaicin-irritated Skin | at 0:30h | 25.00 µv | Standard Deviation 9.69 |
| 200 mg BI 1026706 | Overall Peak-to-Peak (PtP) N2/P2-component Amplitude of (LEP) in Capsaicin-irritated Skin | at 6:00h | 24.06 µv | Standard Deviation 8.24 |
| 200 mg BI 1026706 | Overall Peak-to-Peak (PtP) N2/P2-component Amplitude of (LEP) in Capsaicin-irritated Skin | at 5:00h | 25.31 µv | Standard Deviation 8.06 |
| 200 mg BI 1026706 | Overall Peak-to-Peak (PtP) N2/P2-component Amplitude of (LEP) in Capsaicin-irritated Skin | at 24:00h | 23.91 µv | Standard Deviation 11.18 |
| 200 mg BI 1026706 | Overall Peak-to-Peak (PtP) N2/P2-component Amplitude of (LEP) in Capsaicin-irritated Skin | at -1:20h | 19.57 µv | Standard Deviation 9.24 |
| 200 mg BI 1026706 | Overall Peak-to-Peak (PtP) N2/P2-component Amplitude of (LEP) in Capsaicin-irritated Skin | at 2:00h | 24.98 µv | Standard Deviation 7.29 |
| 200 mg BI 1026706 | Overall Peak-to-Peak (PtP) N2/P2-component Amplitude of (LEP) in Capsaicin-irritated Skin | at 4:00h | 25.26 µv | Standard Deviation 8.33 |
| 200 mg BI 1026706 | Overall Peak-to-Peak (PtP) N2/P2-component Amplitude of (LEP) in Capsaicin-irritated Skin | at 22:00h | 23.53 µv | Standard Deviation 8.44 |
| 200 mg BI 1026706 | Overall Peak-to-Peak (PtP) N2/P2-component Amplitude of (LEP) in Capsaicin-irritated Skin | at 0:30h | 25.35 µv | Standard Deviation 9.12 |
| 200 mg BI 1026706 | Overall Peak-to-Peak (PtP) N2/P2-component Amplitude of (LEP) in Capsaicin-irritated Skin | at 3:00h | 26.13 µv | Standard Deviation 9.35 |
| 200 mg BI 1026706 | Overall Peak-to-Peak (PtP) N2/P2-component Amplitude of (LEP) in Capsaicin-irritated Skin | at 1:00h | 23.11 µv | Standard Deviation 8.96 |
| 200 mg Celecoxib (Cele) | Overall Peak-to-Peak (PtP) N2/P2-component Amplitude of (LEP) in Capsaicin-irritated Skin | at 3:00h | 24.46 µv | Standard Deviation 9.58 |
| 200 mg Celecoxib (Cele) | Overall Peak-to-Peak (PtP) N2/P2-component Amplitude of (LEP) in Capsaicin-irritated Skin | at 6:00h | 23.30 µv | Standard Deviation 9.18 |
| 200 mg Celecoxib (Cele) | Overall Peak-to-Peak (PtP) N2/P2-component Amplitude of (LEP) in Capsaicin-irritated Skin | at 4:00h | 22.76 µv | Standard Deviation 9.37 |
| 200 mg Celecoxib (Cele) | Overall Peak-to-Peak (PtP) N2/P2-component Amplitude of (LEP) in Capsaicin-irritated Skin | at 24:00h | 22.59 µv | Standard Deviation 9.71 |
| 200 mg Celecoxib (Cele) | Overall Peak-to-Peak (PtP) N2/P2-component Amplitude of (LEP) in Capsaicin-irritated Skin | at 5:00h | 23.00 µv | Standard Deviation 10.03 |
| 200 mg Celecoxib (Cele) | Overall Peak-to-Peak (PtP) N2/P2-component Amplitude of (LEP) in Capsaicin-irritated Skin | at 0:30h | 25.20 µv | Standard Deviation 10.61 |
| 200 mg Celecoxib (Cele) | Overall Peak-to-Peak (PtP) N2/P2-component Amplitude of (LEP) in Capsaicin-irritated Skin | at 1:00h | 24.80 µv | Standard Deviation 9.89 |
| 200 mg Celecoxib (Cele) | Overall Peak-to-Peak (PtP) N2/P2-component Amplitude of (LEP) in Capsaicin-irritated Skin | at 2:00h | 24.83 µv | Standard Deviation 10.89 |
| 200 mg Celecoxib (Cele) | Overall Peak-to-Peak (PtP) N2/P2-component Amplitude of (LEP) in Capsaicin-irritated Skin | at -1:20h | 22.44 µv | Standard Deviation 10.94 |
| 200 mg Celecoxib (Cele) | Overall Peak-to-Peak (PtP) N2/P2-component Amplitude of (LEP) in Capsaicin-irritated Skin | at 22:00h | 23.15 µv | Standard Deviation 8.24 |
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-4.6, 2.7]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-6.5, 0.8]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-6.7, 0.6]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-5.3, 2]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-3.5, 3.8]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-3, 4.3]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-4.8, 2.5]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-5, 2.3]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-4.5, 2.8]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-4.7, 2.5]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-7.6, -0.4]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-6, 1.2]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-4.9, 2.3]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-5.3, 1.9]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-3.8, 3.4]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-5, 2.1]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-6.2, 0.9]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-3.9, 3.3]
Secondary
Single Central P2-component Amplitudes - Measured in Capsaicin-irritated Skin Type
Single central P2-component amplitudes - measured in capsaicin-irritated skin type.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Single Central P2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at -1:20h | 10.75 µv | Standard Deviation 5.43 |
| Placebo | Single Central P2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 0:30h | 13.83 µv | Standard Deviation 6.53 |
| Placebo | Single Central P2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 1:00h | 14.25 µv | Standard Deviation 5.64 |
| Placebo | Single Central P2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 2:00h | 14.20 µv | Standard Deviation 5.41 |
| Placebo | Single Central P2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 3:00h | 14.25 µv | Standard Deviation 5.24 |
| Placebo | Single Central P2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 4:00h | 14.01 µv | Standard Deviation 6.07 |
| Placebo | Single Central P2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 5:00h | 13.32 µv | Standard Deviation 5.89 |
| Placebo | Single Central P2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 6:00h | 13.41 µv | Standard Deviation 5.07 |
| Placebo | Single Central P2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 22:00h | 13.16 µv | Standard Deviation 5.03 |
| Placebo | Single Central P2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 24:00h | 11.65 µv | Standard Deviation 3.83 |
| 50 mg BI 1026706 | Single Central P2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 1:00h | 12.24 µv | Standard Deviation 5.86 |
| 50 mg BI 1026706 | Single Central P2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 22:00h | 11.62 µv | Standard Deviation 4.91 |
| 50 mg BI 1026706 | Single Central P2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 2:00h | 12.09 µv | Standard Deviation 4.18 |
| 50 mg BI 1026706 | Single Central P2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 3:00h | 12.97 µv | Standard Deviation 4.18 |
| 50 mg BI 1026706 | Single Central P2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 4:00h | 13.20 µv | Standard Deviation 4.2 |
| 50 mg BI 1026706 | Single Central P2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 5:00h | 12.79 µv | Standard Deviation 4.94 |
| 50 mg BI 1026706 | Single Central P2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 24:00h | 11.24 µv | Standard Deviation 3.91 |
| 50 mg BI 1026706 | Single Central P2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 6:00h | 11.87 µv | Standard Deviation 3.91 |
| 50 mg BI 1026706 | Single Central P2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at -1:20h | 8.88 µv | Standard Deviation 3.8 |
| 50 mg BI 1026706 | Single Central P2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 0:30h | 12.27 µv | Standard Deviation 5.76 |
| 200 mg BI 1026706 | Single Central P2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 6:00h | 11.78 µv | Standard Deviation 4.76 |
| 200 mg BI 1026706 | Single Central P2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 5:00h | 12.47 µv | Standard Deviation 4.63 |
| 200 mg BI 1026706 | Single Central P2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 24:00h | 12.21 µv | Standard Deviation 6.54 |
| 200 mg BI 1026706 | Single Central P2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at -1:20h | 10.30 µv | Standard Deviation 4.51 |
| 200 mg BI 1026706 | Single Central P2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 2:00h | 12.62 µv | Standard Deviation 4.1 |
| 200 mg BI 1026706 | Single Central P2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 4:00h | 12.63 µv | Standard Deviation 4.74 |
| 200 mg BI 1026706 | Single Central P2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 22:00h | 12.00 µv | Standard Deviation 5 |
| 200 mg BI 1026706 | Single Central P2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 0:30h | 13.18 µv | Standard Deviation 5.22 |
| 200 mg BI 1026706 | Single Central P2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 3:00h | 12.74 µv | Standard Deviation 5.02 |
| 200 mg BI 1026706 | Single Central P2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 1:00h | 11.61 µv | Standard Deviation 4.56 |
| 200 mg Celecoxib (Cele) | Single Central P2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 3:00h | 11.94 µv | Standard Deviation 4.78 |
| 200 mg Celecoxib (Cele) | Single Central P2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 6:00h | 11.27 µv | Standard Deviation 4.93 |
| 200 mg Celecoxib (Cele) | Single Central P2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 4:00h | 11.90 µv | Standard Deviation 4.95 |
| 200 mg Celecoxib (Cele) | Single Central P2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 24:00h | 11.24 µv | Standard Deviation 5.35 |
| 200 mg Celecoxib (Cele) | Single Central P2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 5:00h | 11.51 µv | Standard Deviation 4.6 |
| 200 mg Celecoxib (Cele) | Single Central P2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 0:30h | 13.03 µv | Standard Deviation 5.59 |
| 200 mg Celecoxib (Cele) | Single Central P2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 1:00h | 12.77 µv | Standard Deviation 5.67 |
| 200 mg Celecoxib (Cele) | Single Central P2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 2:00h | 12.65 µv | Standard Deviation 5.09 |
| 200 mg Celecoxib (Cele) | Single Central P2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at -1:20h | 11.45 µv | Standard Deviation 6.12 |
| 200 mg Celecoxib (Cele) | Single Central P2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 22:00h | 11.38 µv | Standard Deviation 4.6 |
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-2.7, 1.7]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-3.2, 1.2]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-3.7, 0.8]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-3.3, 1.2]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-2.3, 2.1]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-2.3, 2.1]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-3.7, 0.7]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-3.3, 1.2]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-2.3, 2.1]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-2.5, 1.8]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-4.5, -0.2]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-3.6, 0.8]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-3.5, 0.8]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-3.3, 1]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-2.8, 1.5]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-3.7, 0.6]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-3.1, 1.2]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-1.4, 2.9]
Secondary
Single Central P2-component Amplitudes - Measured in UVB-irradiated Skin Type
Single central P2-component amplitudes - measured in UVB-irradiated skin type.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Single Central P2-component Amplitudes - Measured in UVB-irradiated Skin Type | UVB, at -2:05h | 14.59 µv | Standard Deviation 6.57 |
| Placebo | Single Central P2-component Amplitudes - Measured in UVB-irradiated Skin Type | UVB, at 0:30h | 14.06 µv | Standard Deviation 6.24 |
| Placebo | Single Central P2-component Amplitudes - Measured in UVB-irradiated Skin Type | UVB, at 1:00h | 13.03 µv | Standard Deviation 6.66 |
| Placebo | Single Central P2-component Amplitudes - Measured in UVB-irradiated Skin Type | UVB, at 2:00h | 12.34 µv | Standard Deviation 5.79 |
| Placebo | Single Central P2-component Amplitudes - Measured in UVB-irradiated Skin Type | UVB, at 3:00h | 13.40 µv | Standard Deviation 6.37 |
| Placebo | Single Central P2-component Amplitudes - Measured in UVB-irradiated Skin Type | UVB, at 4:00h | 14.01 µv | Standard Deviation 6.07 |
| Placebo | Single Central P2-component Amplitudes - Measured in UVB-irradiated Skin Type | UVB, at 5:00h | 14.54 µv | Standard Deviation 6.53 |
| Placebo | Single Central P2-component Amplitudes - Measured in UVB-irradiated Skin Type | UVB, at 6:00h | 14.71 µv | Standard Deviation 6.58 |
| Placebo | Single Central P2-component Amplitudes - Measured in UVB-irradiated Skin Type | UVB, at 22:00h | 15.77 µv | Standard Deviation 6.59 |
| Placebo | Single Central P2-component Amplitudes - Measured in UVB-irradiated Skin Type | UVB, at 24:00h | 15.43 µv | Standard Deviation 9.07 |
| 50 mg BI 1026706 | Single Central P2-component Amplitudes - Measured in UVB-irradiated Skin Type | UVB, at 1:00h | 12.69 µv | Standard Deviation 5.21 |
| 50 mg BI 1026706 | Single Central P2-component Amplitudes - Measured in UVB-irradiated Skin Type | UVB, at 22:00h | 15.40 µv | Standard Deviation 5.36 |
| 50 mg BI 1026706 | Single Central P2-component Amplitudes - Measured in UVB-irradiated Skin Type | UVB, at 2:00h | 13.88 µv | Standard Deviation 5.3 |
| 50 mg BI 1026706 | Single Central P2-component Amplitudes - Measured in UVB-irradiated Skin Type | UVB, at 3:00h | 14.08 µv | Standard Deviation 4.99 |
| 50 mg BI 1026706 | Single Central P2-component Amplitudes - Measured in UVB-irradiated Skin Type | UVB, at 4:00h | 14.49 µv | Standard Deviation 7.11 |
| 50 mg BI 1026706 | Single Central P2-component Amplitudes - Measured in UVB-irradiated Skin Type | UVB, at 5:00h | 13.23 µv | Standard Deviation 5.38 |
| 50 mg BI 1026706 | Single Central P2-component Amplitudes - Measured in UVB-irradiated Skin Type | UVB, at 24:00h | 15.09 µv | Standard Deviation 6.23 |
| 50 mg BI 1026706 | Single Central P2-component Amplitudes - Measured in UVB-irradiated Skin Type | UVB, at 6:00h | 12.61 µv | Standard Deviation 5.16 |
| 50 mg BI 1026706 | Single Central P2-component Amplitudes - Measured in UVB-irradiated Skin Type | UVB, at -2:05h | 13.31 µv | Standard Deviation 5.43 |
| 50 mg BI 1026706 | Single Central P2-component Amplitudes - Measured in UVB-irradiated Skin Type | UVB, at 0:30h | 14.23 µv | Standard Deviation 6.26 |
| 200 mg BI 1026706 | Single Central P2-component Amplitudes - Measured in UVB-irradiated Skin Type | UVB, at 6:00h | 13.74 µv | Standard Deviation 7.3 |
| 200 mg BI 1026706 | Single Central P2-component Amplitudes - Measured in UVB-irradiated Skin Type | UVB, at 5:00h | 13.87 µv | Standard Deviation 6.71 |
| 200 mg BI 1026706 | Single Central P2-component Amplitudes - Measured in UVB-irradiated Skin Type | UVB, at 24:00h | 14.40 µv | Standard Deviation 7.63 |
| 200 mg BI 1026706 | Single Central P2-component Amplitudes - Measured in UVB-irradiated Skin Type | UVB, at -2:05h | 14.68 µv | Standard Deviation 4.83 |
| 200 mg BI 1026706 | Single Central P2-component Amplitudes - Measured in UVB-irradiated Skin Type | UVB, at 2:00h | 13.97 µv | Standard Deviation 5.99 |
| 200 mg BI 1026706 | Single Central P2-component Amplitudes - Measured in UVB-irradiated Skin Type | UVB, at 4:00h | 14.49 µv | Standard Deviation 6.04 |
| 200 mg BI 1026706 | Single Central P2-component Amplitudes - Measured in UVB-irradiated Skin Type | UVB, at 22:00h | 15.57 µv | Standard Deviation 8.02 |
| 200 mg BI 1026706 | Single Central P2-component Amplitudes - Measured in UVB-irradiated Skin Type | UVB, at 0:30h | 12.18 µv | Standard Deviation 4.82 |
| 200 mg BI 1026706 | Single Central P2-component Amplitudes - Measured in UVB-irradiated Skin Type | UVB, at 3:00h | 14.44 µv | Standard Deviation 6.16 |
| 200 mg BI 1026706 | Single Central P2-component Amplitudes - Measured in UVB-irradiated Skin Type | UVB, at 1:00h | 13.32 µv | Standard Deviation 6.28 |
| 200 mg Celecoxib (Cele) | Single Central P2-component Amplitudes - Measured in UVB-irradiated Skin Type | UVB, at 3:00h | 12.44 µv | Standard Deviation 5.59 |
| 200 mg Celecoxib (Cele) | Single Central P2-component Amplitudes - Measured in UVB-irradiated Skin Type | UVB, at 6:00h | 12.73 µv | Standard Deviation 4.95 |
| 200 mg Celecoxib (Cele) | Single Central P2-component Amplitudes - Measured in UVB-irradiated Skin Type | UVB, at 4:00h | 12.10 µv | Standard Deviation 5.11 |
| 200 mg Celecoxib (Cele) | Single Central P2-component Amplitudes - Measured in UVB-irradiated Skin Type | UVB, at 24:00h | 13.36 µv | Standard Deviation 5.73 |
| 200 mg Celecoxib (Cele) | Single Central P2-component Amplitudes - Measured in UVB-irradiated Skin Type | UVB, at 5:00h | 12.03 µv | Standard Deviation 5.81 |
| 200 mg Celecoxib (Cele) | Single Central P2-component Amplitudes - Measured in UVB-irradiated Skin Type | UVB, at 0:30h | 12.98 µv | Standard Deviation 5.86 |
| 200 mg Celecoxib (Cele) | Single Central P2-component Amplitudes - Measured in UVB-irradiated Skin Type | UVB, at 1:00h | 13.31 µv | Standard Deviation 5.52 |
| 200 mg Celecoxib (Cele) | Single Central P2-component Amplitudes - Measured in UVB-irradiated Skin Type | UVB, at 2:00h | 12.65 µv | Standard Deviation 4.56 |
| 200 mg Celecoxib (Cele) | Single Central P2-component Amplitudes - Measured in UVB-irradiated Skin Type | UVB, at -2:05h | 12.90 µv | Standard Deviation 5.08 |
| 200 mg Celecoxib (Cele) | Single Central P2-component Amplitudes - Measured in UVB-irradiated Skin Type | UVB, at 22:00h | 16.07 µv | Standard Deviation 6.61 |
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-1.5, 3.1]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-1.8, 2.8]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-0.2, 4.4]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-1, 3.6]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-1.2, 3.4]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-2.9, 1.7]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-3.7, 0.9]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-2.1, 2.5]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-1.9, 2.7]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-4, 0.6]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-1.8, 2.8]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-0.4, 4.2]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-1, 3.5]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-1.6, 2.9]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-2.7, 1.8]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-3, 1.5]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-2.2, 2.4]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-3, 1.6]
Secondary
Single Peripheral N2-component Amplitudes - Measured in Capsaicin-irritated Skin Type
Single peripheral N2-component amplitudes - measured in capsaicin-irritated skin type.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Single Peripheral N2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at -1:20h | 10.42 µv | Standard Deviation 5.76 |
| Placebo | Single Peripheral N2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 0:30h | 13.95 µv | Standard Deviation 5.59 |
| Placebo | Single Peripheral N2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 1:00h | 13.70 µv | Standard Deviation 5.27 |
| Placebo | Single Peripheral N2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 2:00h | 13.77 µv | Standard Deviation 5.39 |
| Placebo | Single Peripheral N2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 3:00h | 13.44 µv | Standard Deviation 5.07 |
| Placebo | Single Peripheral N2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 4:00h | 13.52 µv | Standard Deviation 4.4 |
| Placebo | Single Peripheral N2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 5:00h | 12.93 µv | Standard Deviation 4.11 |
| Placebo | Single Peripheral N2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 6:00h | 12.36 µv | Standard Deviation 5.43 |
| Placebo | Single Peripheral N2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 22:00h | 13.59 µv | Standard Deviation 5.03 |
| Placebo | Single Peripheral N2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 24:00h | 13.18 µv | Standard Deviation 5.83 |
| 50 mg BI 1026706 | Single Peripheral N2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 1:00h | 11.43 µv | Standard Deviation 5.83 |
| 50 mg BI 1026706 | Single Peripheral N2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 22:00h | 12.84 µv | Standard Deviation 5.68 |
| 50 mg BI 1026706 | Single Peripheral N2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 2:00h | 11.85 µv | Standard Deviation 4.94 |
| 50 mg BI 1026706 | Single Peripheral N2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 3:00h | 12.71 µv | Standard Deviation 5.59 |
| 50 mg BI 1026706 | Single Peripheral N2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 4:00h | 13.54 µv | Standard Deviation 4.58 |
| 50 mg BI 1026706 | Single Peripheral N2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 5:00h | 13.01 µv | Standard Deviation 5.65 |
| 50 mg BI 1026706 | Single Peripheral N2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 24:00h | 11.71 µv | Standard Deviation 4.87 |
| 50 mg BI 1026706 | Single Peripheral N2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 6:00h | 12.27 µv | Standard Deviation 5.52 |
| 50 mg BI 1026706 | Single Peripheral N2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at -1:20h | 9.65 µv | Standard Deviation 4.63 |
| 50 mg BI 1026706 | Single Peripheral N2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 0:30h | 12.73 µv | Standard Deviation 5.03 |
| 200 mg BI 1026706 | Single Peripheral N2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 6:00h | 12.27 µv | Standard Deviation 4.46 |
| 200 mg BI 1026706 | Single Peripheral N2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 5:00h | 12.84 µv | Standard Deviation 4.7 |
| 200 mg BI 1026706 | Single Peripheral N2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 24:00h | 11.70 µv | Standard Deviation 5.66 |
| 200 mg BI 1026706 | Single Peripheral N2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at -1:20h | 9.27 µv | Standard Deviation 5.47 |
| 200 mg BI 1026706 | Single Peripheral N2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 2:00h | 12.36 µv | Standard Deviation 4.43 |
| 200 mg BI 1026706 | Single Peripheral N2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 4:00h | 12.63 µv | Standard Deviation 4.2 |
| 200 mg BI 1026706 | Single Peripheral N2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 22:00h | 11.53 µv | Standard Deviation 4.95 |
| 200 mg BI 1026706 | Single Peripheral N2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 0:30h | 12.17 µv | Standard Deviation 5.3 |
| 200 mg BI 1026706 | Single Peripheral N2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 3:00h | 13.39 µv | Standard Deviation 5.23 |
| 200 mg BI 1026706 | Single Peripheral N2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 1:00h | 11.50 µv | Standard Deviation 5.48 |
| 200 mg Celecoxib (Cele) | Single Peripheral N2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 3:00h | 12.51 µv | Standard Deviation 6.2 |
| 200 mg Celecoxib (Cele) | Single Peripheral N2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 6:00h | 12.03 µv | Standard Deviation 5.39 |
| 200 mg Celecoxib (Cele) | Single Peripheral N2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 4:00h | 10.86 µv | Standard Deviation 6.05 |
| 200 mg Celecoxib (Cele) | Single Peripheral N2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 24:00h | 11.35 µv | Standard Deviation 5.53 |
| 200 mg Celecoxib (Cele) | Single Peripheral N2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 5:00h | 11.49 µv | Standard Deviation 6.45 |
| 200 mg Celecoxib (Cele) | Single Peripheral N2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 0:30h | 12.17 µv | Standard Deviation 6.39 |
| 200 mg Celecoxib (Cele) | Single Peripheral N2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 1:00h | 12.03 µv | Standard Deviation 5.34 |
| 200 mg Celecoxib (Cele) | Single Peripheral N2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 2:00h | 12.18 µv | Standard Deviation 6.26 |
| 200 mg Celecoxib (Cele) | Single Peripheral N2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at -1:20h | 10.99 µv | Standard Deviation 5.89 |
| 200 mg Celecoxib (Cele) | Single Peripheral N2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | at 22:00h | 11.77 µv | Standard Deviation 5.39 |
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-3.4, 1.5]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-4.4, 0.5]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-4.1, 0.8]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-3, 1.9]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-2.1, 2.7]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-2.1, 2.8]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-2.3, 2.6]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-3, 1.9]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-3.6, 1.3]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-3.7, 1.1]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-4.3, 0.5]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-3.6, 1.3]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-2.3, 2.5]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-3.1, 1.7]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-2, 2.8]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-2.3, 2.6]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-4.1, 0.7]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-3.6, 1.2]
Secondary
Single Peripheral N2-component Amplitudes - Measured in UVB-irradiated Skin Type
Single peripheral N2-component amplitudes - measured in UVB-irradiated skin type.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Single Peripheral N2-component Amplitudes - Measured in UVB-irradiated Skin Type | at -2:05h | 14.62 µv | Standard Deviation 4.02 |
| Placebo | Single Peripheral N2-component Amplitudes - Measured in UVB-irradiated Skin Type | at 0:30h | 14.48 µv | Standard Deviation 5.01 |
| Placebo | Single Peripheral N2-component Amplitudes - Measured in UVB-irradiated Skin Type | at 1:00h | 12.54 µv | Standard Deviation 5.15 |
| Placebo | Single Peripheral N2-component Amplitudes - Measured in UVB-irradiated Skin Type | at 2:00h | 14.40 µv | Standard Deviation 4.37 |
| Placebo | Single Peripheral N2-component Amplitudes - Measured in UVB-irradiated Skin Type | at 3:00h | 16.08 µv | Standard Deviation 4.74 |
| Placebo | Single Peripheral N2-component Amplitudes - Measured in UVB-irradiated Skin Type | at 4:00h | 16.52 µv | Standard Deviation 4.99 |
| Placebo | Single Peripheral N2-component Amplitudes - Measured in UVB-irradiated Skin Type | at 5:00h | 17.20 µv | Standard Deviation 5.37 |
| Placebo | Single Peripheral N2-component Amplitudes - Measured in UVB-irradiated Skin Type | at 6:00h | 17.46 µv | Standard Deviation 5.77 |
| Placebo | Single Peripheral N2-component Amplitudes - Measured in UVB-irradiated Skin Type | at 22:00h | 18.71 µv | Standard Deviation 6.36 |
| Placebo | Single Peripheral N2-component Amplitudes - Measured in UVB-irradiated Skin Type | at 24:00h | 19.01 µv | Standard Deviation 8.69 |
| 50 mg BI 1026706 | Single Peripheral N2-component Amplitudes - Measured in UVB-irradiated Skin Type | at 1:00h | 14.42 µv | Standard Deviation 5.76 |
| 50 mg BI 1026706 | Single Peripheral N2-component Amplitudes - Measured in UVB-irradiated Skin Type | at 22:00h | 17.12 µv | Standard Deviation 5.23 |
| 50 mg BI 1026706 | Single Peripheral N2-component Amplitudes - Measured in UVB-irradiated Skin Type | at 2:00h | 14.90 µv | Standard Deviation 5.5 |
| 50 mg BI 1026706 | Single Peripheral N2-component Amplitudes - Measured in UVB-irradiated Skin Type | at 3:00h | 16.85 µv | Standard Deviation 5.08 |
| 50 mg BI 1026706 | Single Peripheral N2-component Amplitudes - Measured in UVB-irradiated Skin Type | at 4:00h | 16.92 µv | Standard Deviation 5.37 |
| 50 mg BI 1026706 | Single Peripheral N2-component Amplitudes - Measured in UVB-irradiated Skin Type | at 5:00h | 16.87 µv | Standard Deviation 4.81 |
| 50 mg BI 1026706 | Single Peripheral N2-component Amplitudes - Measured in UVB-irradiated Skin Type | at 24:00h | 17.74 µv | Standard Deviation 5.31 |
| 50 mg BI 1026706 | Single Peripheral N2-component Amplitudes - Measured in UVB-irradiated Skin Type | at 6:00h | 15.51 µv | Standard Deviation 5.28 |
| 50 mg BI 1026706 | Single Peripheral N2-component Amplitudes - Measured in UVB-irradiated Skin Type | at -2:05h | 12.78 µv | Standard Deviation 6.42 |
| 50 mg BI 1026706 | Single Peripheral N2-component Amplitudes - Measured in UVB-irradiated Skin Type | at 0:30h | 13.77 µv | Standard Deviation 6.03 |
| 200 mg BI 1026706 | Single Peripheral N2-component Amplitudes - Measured in UVB-irradiated Skin Type | at 6:00h | 15.30 µv | Standard Deviation 4.94 |
| 200 mg BI 1026706 | Single Peripheral N2-component Amplitudes - Measured in UVB-irradiated Skin Type | at 5:00h | 16.93 µv | Standard Deviation 5.69 |
| 200 mg BI 1026706 | Single Peripheral N2-component Amplitudes - Measured in UVB-irradiated Skin Type | at 24:00h | 18.58 µv | Standard Deviation 6.55 |
| 200 mg BI 1026706 | Single Peripheral N2-component Amplitudes - Measured in UVB-irradiated Skin Type | at -2:05h | 14.25 µv | Standard Deviation 4.73 |
| 200 mg BI 1026706 | Single Peripheral N2-component Amplitudes - Measured in UVB-irradiated Skin Type | at 2:00h | 15.06 µv | Standard Deviation 4.48 |
| 200 mg BI 1026706 | Single Peripheral N2-component Amplitudes - Measured in UVB-irradiated Skin Type | at 4:00h | 16.95 µv | Standard Deviation 4.27 |
| 200 mg BI 1026706 | Single Peripheral N2-component Amplitudes - Measured in UVB-irradiated Skin Type | at 22:00h | 18.93 µv | Standard Deviation 6.11 |
| 200 mg BI 1026706 | Single Peripheral N2-component Amplitudes - Measured in UVB-irradiated Skin Type | at 0:30h | 12.70 µv | Standard Deviation 4.99 |
| 200 mg BI 1026706 | Single Peripheral N2-component Amplitudes - Measured in UVB-irradiated Skin Type | at 3:00h | 14.58 µv | Standard Deviation 3.93 |
| 200 mg BI 1026706 | Single Peripheral N2-component Amplitudes - Measured in UVB-irradiated Skin Type | at 1:00h | 13.45 µv | Standard Deviation 5.34 |
| 200 mg Celecoxib (Cele) | Single Peripheral N2-component Amplitudes - Measured in UVB-irradiated Skin Type | at 3:00h | 12.61 µv | Standard Deviation 4.36 |
| 200 mg Celecoxib (Cele) | Single Peripheral N2-component Amplitudes - Measured in UVB-irradiated Skin Type | at 6:00h | 14.04 µv | Standard Deviation 5.51 |
| 200 mg Celecoxib (Cele) | Single Peripheral N2-component Amplitudes - Measured in UVB-irradiated Skin Type | at 4:00h | 11.87 µv | Standard Deviation 4.35 |
| 200 mg Celecoxib (Cele) | Single Peripheral N2-component Amplitudes - Measured in UVB-irradiated Skin Type | at 24:00h | 16.67 µv | Standard Deviation 5.84 |
| 200 mg Celecoxib (Cele) | Single Peripheral N2-component Amplitudes - Measured in UVB-irradiated Skin Type | at 5:00h | 12.07 µv | Standard Deviation 4.68 |
| 200 mg Celecoxib (Cele) | Single Peripheral N2-component Amplitudes - Measured in UVB-irradiated Skin Type | at 0:30h | 13.62 µv | Standard Deviation 4.55 |
| 200 mg Celecoxib (Cele) | Single Peripheral N2-component Amplitudes - Measured in UVB-irradiated Skin Type | at 1:00h | 14.29 µv | Standard Deviation 4.67 |
| 200 mg Celecoxib (Cele) | Single Peripheral N2-component Amplitudes - Measured in UVB-irradiated Skin Type | at 2:00h | 12.22 µv | Standard Deviation 3.59 |
| 200 mg Celecoxib (Cele) | Single Peripheral N2-component Amplitudes - Measured in UVB-irradiated Skin Type | at -2:05h | 13.45 µv | Standard Deviation 5.61 |
| 200 mg Celecoxib (Cele) | Single Peripheral N2-component Amplitudes - Measured in UVB-irradiated Skin Type | at 22:00h | 16.99 µv | Standard Deviation 6.35 |
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-2.8, 2.5]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-0.5, 4.9]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-1.7, 3.7]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-1.4, 3.9]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-2, 3.4]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-2.3, 3]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-4.3, 1.1]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-4.2, 1.2]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-3.5, 1.8]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-4.2, 1]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-1.5, 3.7]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-1.8, 3.4]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-3.9, 1.3]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-2, 3.2]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-2.6, 2.6]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-4.7, 0.6]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-2.2, 3]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-2.9, 2.3]
Secondary
Weighted Needle (Pain) Threshold (WNT) in the Secondary Flare Area of Capsaicin-irritated Skin
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).
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| 50 mg BI 1026706 | Weighted Needle (Pain) Threshold (WNT) in the Secondary Flare Area of Capsaicin-irritated Skin | at -1:20h | 366.65 millinewton (mN) | Standard Deviation 123.95 |
| 50 mg BI 1026706 | Weighted Needle (Pain) Threshold (WNT) in the Secondary Flare Area of Capsaicin-irritated Skin | at 1:00h | 285.35 millinewton (mN) | Standard Deviation 144.26 |
| 50 mg BI 1026706 | Weighted Needle (Pain) Threshold (WNT) in the Secondary Flare Area of Capsaicin-irritated Skin | at 0:30h | 295.65 millinewton (mN) | Standard Deviation 126.48 |
| 50 mg BI 1026706 | Weighted Needle (Pain) Threshold (WNT) in the Secondary Flare Area of Capsaicin-irritated Skin | at 4:00h | 265.77 millinewton (mN) | Standard Deviation 151.62 |
| 50 mg BI 1026706 | Weighted Needle (Pain) Threshold (WNT) in the Secondary Flare Area of Capsaicin-irritated Skin | at 3:00h | 265.58 millinewton (mN) | Standard Deviation 147.81 |
| 50 mg BI 1026706 | Weighted Needle (Pain) Threshold (WNT) in the Secondary Flare Area of Capsaicin-irritated Skin | at 5:00h | 270.27 millinewton (mN) | Standard Deviation 157.88 |
| 50 mg BI 1026706 | Weighted Needle (Pain) Threshold (WNT) in the Secondary Flare Area of Capsaicin-irritated Skin | at 24:00h | 312.85 millinewton (mN) | Standard Deviation 156.45 |
| 50 mg BI 1026706 | Weighted Needle (Pain) Threshold (WNT) in the Secondary Flare Area of Capsaicin-irritated Skin | at 2:00h | 287.94 millinewton (mN) | Standard Deviation 148.7 |
| 50 mg BI 1026706 | Weighted Needle (Pain) Threshold (WNT) in the Secondary Flare Area of Capsaicin-irritated Skin | at 6:00h | 281.21 millinewton (mN) | Standard Deviation 163.78 |
| 50 mg BI 1026706 | Weighted Needle (Pain) Threshold (WNT) in the Secondary Flare Area of Capsaicin-irritated Skin | at 22:00h | 313.77 millinewton (mN) | Standard Deviation 159.07 |
| 200 mg BI 1026706 | Weighted Needle (Pain) Threshold (WNT) in the Secondary Flare Area of Capsaicin-irritated Skin | at -1:20h | 369.98 millinewton (mN) | Standard Deviation 142.2 |
| 200 mg BI 1026706 | Weighted Needle (Pain) Threshold (WNT) in the Secondary Flare Area of Capsaicin-irritated Skin | at 3:00h | 222.66 millinewton (mN) | Standard Deviation 119.98 |
| 200 mg BI 1026706 | Weighted Needle (Pain) Threshold (WNT) in the Secondary Flare Area of Capsaicin-irritated Skin | at 4:00h | 235.15 millinewton (mN) | Standard Deviation 114.6 |
| 200 mg BI 1026706 | Weighted Needle (Pain) Threshold (WNT) in the Secondary Flare Area of Capsaicin-irritated Skin | at 5:00h | 228.09 millinewton (mN) | Standard Deviation 122.48 |
| 200 mg BI 1026706 | Weighted Needle (Pain) Threshold (WNT) in the Secondary Flare Area of Capsaicin-irritated Skin | at 6:00h | 234.30 millinewton (mN) | Standard Deviation 124.55 |
| 200 mg BI 1026706 | Weighted Needle (Pain) Threshold (WNT) in the Secondary Flare Area of Capsaicin-irritated Skin | at 0:30h | 285.78 millinewton (mN) | Standard Deviation 122.17 |
| 200 mg BI 1026706 | Weighted Needle (Pain) Threshold (WNT) in the Secondary Flare Area of Capsaicin-irritated Skin | at 1:00h | 262.20 millinewton (mN) | Standard Deviation 117.1 |
| 200 mg BI 1026706 | Weighted Needle (Pain) Threshold (WNT) in the Secondary Flare Area of Capsaicin-irritated Skin | at 2:00h | 225.48 millinewton (mN) | Standard Deviation 112.11 |
| 200 mg BI 1026706 | Weighted Needle (Pain) Threshold (WNT) in the Secondary Flare Area of Capsaicin-irritated Skin | at 22:00h | 274.92 millinewton (mN) | Standard Deviation 125.73 |
| 200 mg BI 1026706 | Weighted Needle (Pain) Threshold (WNT) in the Secondary Flare Area of Capsaicin-irritated Skin | at 24:00h | 277.38 millinewton (mN) | Standard Deviation 148.59 |
| 200 mg Celecoxib (Cele) | Weighted Needle (Pain) Threshold (WNT) in the Secondary Flare Area of Capsaicin-irritated Skin | at 6:00h | 273.42 millinewton (mN) | Standard Deviation 125.06 |
| 200 mg Celecoxib (Cele) | Weighted Needle (Pain) Threshold (WNT) in the Secondary Flare Area of Capsaicin-irritated Skin | at 5:00h | 266.83 millinewton (mN) | Standard Deviation 141.25 |
| 200 mg Celecoxib (Cele) | Weighted Needle (Pain) Threshold (WNT) in the Secondary Flare Area of Capsaicin-irritated Skin | at 2:00h | 254.70 millinewton (mN) | Standard Deviation 150.1 |
| 200 mg Celecoxib (Cele) | Weighted Needle (Pain) Threshold (WNT) in the Secondary Flare Area of Capsaicin-irritated Skin | at 24:00h | 340.76 millinewton (mN) | Standard Deviation 147.36 |
| 200 mg Celecoxib (Cele) | Weighted Needle (Pain) Threshold (WNT) in the Secondary Flare Area of Capsaicin-irritated Skin | at 22:00h | 330.26 millinewton (mN) | Standard Deviation 147.94 |
| 200 mg Celecoxib (Cele) | Weighted Needle (Pain) Threshold (WNT) in the Secondary Flare Area of Capsaicin-irritated Skin | at 4:00h | 255.45 millinewton (mN) | Standard Deviation 140.19 |
| 200 mg Celecoxib (Cele) | Weighted Needle (Pain) Threshold (WNT) in the Secondary Flare Area of Capsaicin-irritated Skin | at 0:30h | 301.48 millinewton (mN) | Standard Deviation 157.97 |
| 200 mg Celecoxib (Cele) | Weighted Needle (Pain) Threshold (WNT) in the Secondary Flare Area of Capsaicin-irritated Skin | at -1:20h | 347.12 millinewton (mN) | Standard Deviation 133.57 |
| 200 mg Celecoxib (Cele) | Weighted Needle (Pain) Threshold (WNT) in the Secondary Flare Area of Capsaicin-irritated Skin | at 3:00h | 265.51 millinewton (mN) | Standard Deviation 145.58 |
| 200 mg Celecoxib (Cele) | Weighted Needle (Pain) Threshold (WNT) in the Secondary Flare Area of Capsaicin-irritated Skin | at 1:00h | 280.38 millinewton (mN) | Standard Deviation 160.61 |
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-88.3, 29]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-75.5, 42.9]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-42.2, 57.5]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-66.7, 25.8]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-58.6, 33.4]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-47.8, 46.5]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-74.3, 35.7]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-79.9, 29.5]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-70.9, 36.5]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-97.7, 18.5]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-95.7, 21.6]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-101.8, -3.1]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-105.6, -14.1]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-85.5, 5.5]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-85.6, 7.6]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-118.1, -9.3]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-115.6, -7.2]
Comparison: A repeated measures model was applied to the change from baseline of the endpoint which included the fixed effects 'period', 'treatment', 'mean of the period baselines of primary PD endpoint', 'baseline of primary PD endpoint of the respective period', and 'session', the random effect 'subject', and the interaction terms 'mean of the period baselines × session', 'baseline of the respective period × session', 'period × session', and 'treatment × session'.95% CI: [-102.6, 3.8]