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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-005691-33 | EudraCT Number | EudraCT |
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Treatment 1: BI 1026706 | Experimental | BI 1026706 plus matching placebo to BI 1026706 Powder for Oral Solution (PfOS) and placebo tablet |
|
| Test Treatment 2: BI 1026706 | Experimental | BI 1026706 and placebo tablet |
|
| Reference Treatment 1: BI 1026706 | Experimental | Matching placebo to BI 1026706 PfOS and placebo tablet |
|
| Reference Treatment 2: Celecoxib | Experimental | Celecoxib hard capsule as active comparator plus matching placebo to BI 1026706 PfOS |
|
| Reference Treatment 3: Pregabalin | Experimental | Pregabalin hard capsule as active comparator plus matching placebo to BI 1026706 PfOS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo to BI 1026706 | Drug | Placebo tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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]) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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]) |
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1320.3.1 Boehringer Ingelheim Investigational Site | Dörnach | Germany |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 50mg BI1026706/200mg BI1026706/Placebo/200mg Cele/150mg Preg | Single dose administration per treatment. A washout period of at least 6 days was required between the treatments. Treatment sequence A: 50mg BI 1026706 (powder for oral solution [PfOS]), 200mg BI 1026706 (PfOS), placebo (matching placebo to BI 1026706), 200mg Celecoxib (Cele, hard capsule), 150mg Pregabalin (Preg, hard capsule). Mode of admin.: oral with 200 mL of water. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 (2 Days) |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Pregabalin | Drug | Pregabalin hard capsule |
|
| BI 1026706 | Drug | BI 1026706 oral solution |
|
| Celecoxib | Drug | Celecoxib hard capsule |
|
| Single "Peripheral" N2-component Amplitudes - Measured in UVB-irradiated Skin Type |
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 Capsaicin-irritated 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 "Central" P2-component Amplitudes - Measured in UVB-irradiated 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 Capsaicin-irritated Skin Type | 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]) |
| 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'. | 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 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'. | 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 | 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). | 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]) |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 150mg Preg/200mg Cele/200mg BI1026706/Placebo/50mg BI1026706 | Single dose administration per treatment. A washout period of at least 6 days was required between the treatments. Treatment sequence E: 150mg Preg (hard capsule), 200mg Cele (hard capsule), 200mg BI 1026706 (PfOS), placebo (matching placebo), 50mg BI 1026706 (PfOS). Mode of admin.: oral with 200 mL of water. |
| COMPLETED |
|
| NOT COMPLETED |
|
| Washout Period 1 (6 Days) |
|
| Period 2 (2 Days) |
|
| Washout Period 2 (6 Days) |
|
| Period 3 (2 Days) |
|
| Washout Period 3 (6 Days) |
|
| Period 4 (2 Days) |
|
| Washout Period 4 (6 Days) |
|
|
| Period 5 (2 Days) |
|
Treated set (TS) : all subjects who were dispensed study medication and were documented to have taken at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | 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. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | 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. | Posted | Mean | Standard Deviation | Microvolts (µv) | 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]) |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | PDS | Posted | Mean | Standard Deviation | µv | 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]) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Single "Peripheral" N2-component Amplitudes - Measured in UVB-irradiated Skin Type | Single "peripheral" N2-component amplitudes - measured in UVB-irradiated skin type. | PDS | Posted | Mean | Standard Deviation | µv | 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]) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Single "Peripheral" N2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | Single "peripheral" N2-component amplitudes - measured in capsaicin-irritated skin type. | PDS | Posted | Mean | Standard Deviation | µv | 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]) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Single "Central" P2-component Amplitudes - Measured in UVB-irradiated Skin Type | Single "central" P2-component amplitudes - measured in UVB-irradiated skin type. | PDS | Posted | Mean | Standard Deviation | µv | 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]) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Single "Central" P2-component Amplitudes - Measured in Capsaicin-irritated Skin Type | Single "central" P2-component amplitudes - measured in capsaicin-irritated skin type. | PDS | Posted | Mean | Standard Deviation | µv | 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]) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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'. | PDS | Posted | Mean | Standard Deviation | units on a scale | 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]) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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'. | PDS | Posted | Mean | Standard Deviation | units on a scale | 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]) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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). | PDS | Posted | Mean | Standard Deviation | millinewton (mN) | 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]) |
|
From the start day of trial medication administration to Day 3 ( 3 days after the last trial medication)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Matching placebo to BI 1026706, Mode of Administration: Oral with 200 mL of water. | 0 | 25 | 3 | 25 | ||
| EG001 | 50 mg BI 1026706 | treatment group: 50 mg BI 1026706 | 0 | 24 | 2 | 24 | ||
| EG002 | 200 mg BI 1026706 | treatment group: 200 BI 1026706 | 0 | 25 | 3 | 25 | ||
| EG003 | 200 mg Celecoxib | treatment group: 200 mg celecoxib | 0 | 25 | 2 | 25 | ||
| EG004 | 150 mg Pregabalin | treatment group: 150 mg pregabalin | 0 | 25 | 17 | 25 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinus bradycardia | Cardiac disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MEDDRA 17.0 | Systematic Assessment |
|
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| D000068579 | Celecoxib |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
|
| at 0:30h |
|
|
| at 1:00h |
|
|
| at 2:00h |
|
|
| at 3:00h |
|
|
| at 4:00h |
|
|
| at 5:00h |
|
|
| at 6:00h |
|
|
| at 22:00h |
|
|
| at 24:00h |
|
|
| Superiority or Other |
| 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'. | adjusted mean difference | 2.66 | Standard Error of the Mean | 2.0796 | 2-Sided | 95 | -1.4 | 6.8 | Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration. | Superiority or Other |
| 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'. | adjusted mean difference | 3.00 | Standard Error of the Mean | 2.0792 | 2-Sided | 95 | -1.1 | 7.1 | Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration. | Superiority or Other |
| 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'. | adjusted mean difference | 2.53 | Standard Error of the Mean | 2.0790 | 2-Sided | 95 | -1.6 | 6.6 | Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration. | Superiority or Other |
| 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'. | adjusted mean difference | 1.72 | Standard Error of the Mean | 2.0789 | 2-Sided | 95 | -2.4 | 5.8 | Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration. | Superiority or Other |
| 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'. | adjusted mean difference | -0.15 | Standard Error of the Mean | 2.0790 | 2-Sided | 95 | -4.2 | 3.9 | Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration. | Superiority or Other |
| 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'. | adjusted mean difference | -3.15 | Standard Error of the Mean | 2.0792 | 2-Sided | 95 | -7.2 | 0.9 | Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration. | Superiority or Other |
| 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'. | adjusted mean difference | -1.31 | Standard Error of the Mean | 2.0796 | 2-Sided | 95 | -5.4 | 2.8 | Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration. | Superiority or Other |
| 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'. | adjusted mean difference | -0.15 | Standard Error of the Mean | 2.0801 | 2-Sided | 95 | -4.2 | 3.9 | Adjusted mean treatment difference between 50 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration. | Superiority or Other |
| 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'. | Adjusted mean difference | -2.68 | Standard Error of the Mean | 2.0282 | 2-Sided | 95 | -6.7 | 1.3 | Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 0:30h after the dose administration. | Superiority or Other |
| 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'. | adjusted mean difference | 1.58 | Standard Error of the Mean | 2.0279 | 2-Sided | 95 | -2.4 | 5.6 | Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 1:00h after the dose administration. | Superiority or Other |
| 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'. | adjusted mean difference | 2.63 | Standard Error of the Mean | 2.0278 | 2-Sided | 95 | -1.4 | 6.6 | Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 2:00h after the dose administration. | Superiority or Other |
| 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'. | adjusted mean difference | -0.17 | Standard Error of the Mean | 2.0277 | 2-Sided | 95 | -4.2 | 3.8 | Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 3:00h after the dose administration. | Superiority or Other |
| 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'. | adjusted mean difference | 1.20 | Standard Error of the Mean | 2.0276 | 2-Sided | 95 | -2.8 | 5.2 | Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 4:00h after the dose administration. | Superiority or Other |
| 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'. | adjusted mean difference | -0.59 | Standard Error of the Mean | 2.0277 | 2-Sided | 95 | -4.6 | 3.4 | Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 5:00h after the dose administration. | Superiority or Other |
| 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'. | adjusted mean difference | -2.88 | Standard Error of the Mean | 2.0278 | 2-Sided | 95 | -6.9 | 1.1 | Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 6:00h after the dose administration. | Superiority or Other |
| 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'. | adjusted mean difference | 0.43 | Standard Error of the Mean | 2.0279 | 2-Sided | 95 | -3.6 | 4.4 | Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 22:00h after the dose administration. | Superiority or Other |
| 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'. | adjusted mean difference | -1.04 | Standard Error of the Mean | 2.0282 | 2-Sided | 95 | -5.0 | 2.9 | Adjusted mean treatment difference between 200 mg BI 1026706 and placebo in the change from baseline. This analysis represents the results evaluated at 24:00h after the dose administration. | Superiority or Other |
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| 150 mg Pregabalin (Prega) |
150 mg pregabalin (prega) hard capsule, single dose, mode of admin.: oral with 200 mL of water. |
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