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See Detailed Description
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The study is designed to assess if spinal cord injury patients have reduced pain after taking either pregabalin or placebo in a cross over design. Patients had either pain at the level of their injury or below the level of their injury.
This methodology study was terminated on October 13, 2008 based on interim results for an exploratory, novel endpoint. The results of the primary analysis at the interim for N=12 patients showed results that generally favored pregabalin but were not statistically significant compared to placebo. Based on the estimated conditional power, this result is unlikely to change with full recruitment of N=24 patients and therefore the data monitoring committee recommended termination of the trial. The decision to terminate the trial was not based on any safety concerns.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregabalin | Experimental |
| |
| Placebo | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin | Drug | Pregabalin 150mg capsules BID for 7.5 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Present Pain Intensity Score | Present pain intensity score: 0-10 numeric rating scale (NRS), 0 (no pain) to 10 (worst possible pain). | Day 1: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours (post-dose); Day 8: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours (post-dose) |
| Measure | Description | Time Frame |
|---|---|---|
| Daily Pain Score | Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning. 0-10 numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain). | Predose: Daily from 7 days before Visit 2 (start of Intervention 1) until the morning of Visit 5 (end of Intervention 2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Randwick | New South Wales | 2031 | Australia | ||
| Pfizer Investigational Site |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Subjects completed a 1-2 week screening period to determine eligibility criteria prior to enrollment. Of 24 subjects screened, 15 subjects were enrolled into the study and randomized.
Subjects were enrolled at 4 study centers and participated in the study between 13 February 2007 and 01 October 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pregabalin First Then Placebo | First Intervention Pregabalin Days 1-7: 150 mg twice a day (BID); Day 8: 150 mg in the morning. Second Intervention Placebo Days 1-7: twice a day (BID); Day 8: 1 dose in the morning. |
| FG001 | Placebo First Then Pregabalin |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First Intervention |
|
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| Placebo for pregabalin |
| Drug |
Placebo capsules BID for 7.5 days |
|
| Dynamic Allodynia Area |
Area of dynamic allodynia was assessed using a brush (SENSElab Brush 05; velocity approximately 20 millimeters per second [mm/s]) by stimulating along a pattern of 8 radial spokes. Stimulation was started from the non-painful perimetry. Subjects were asked to report change in sensation from non-painful to painful and the spot was marked onto the skin. The area of dynamic allodynia was determined from these 8 distances by calculating the area of an octagon (in centimeter squared [cm2]). |
| Screening, Days 1 & 8: 0 (pre-dose) & 4 hours post-dose, |
| Dynamic Allodynia Pain Score | Five strokes (each approx. 6 centimeters [cm] long) were applied with a standardized brush (SENSELab Brush 05) across the painful site (and a control site) at a constant velocity (20 millimeters per second [mm/sec]). Pain in response to brush stimulation of the allodynic area was recorded using an 11-point numeric rating scale from 0 (no pain) to 10 (worst possible pain). Patients were asked to give a pain rating after each brush stroke. A painful sensation was considered as representing brush allodynia. | Screening, Days 1 & 8: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, and 6 hours post-dose |
| Punctate Allodynia Area | Area of punctate allodynia was determined using a von Frey filament (OptiHair2). Stimulation was started from the non-painful perimetry and repeated along a pattern of 8 radial spokes. With a movement along each spoke at steps of 5 millimeters (mm), the subjects reported sensation changes from non-painful to painful and the spot was marked on the skin. The area of punctate allodynia was determined from these 8 distances by calculating the area of an octagon (in square centimeter(s)[cm2]). | Screening, Days 1 & 8: 0 (pre-dose) and 4 hours post-dose |
| Mechanical Pain Sensitivity Stimulus-Response Function | Mechanical pain sensitivity stimulus response function was assessed at the control and painful sites using calibrated von Frey monofilaments and the SENSElab brush. Seven different von Frey monofilaments (8 -512 milliNewtons [mN], force increases by a factor of two from filament to filament) and the brush were applied in a predetermined pseudo-random order. Pain rating for each stimulus: 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst possible pain). | Screening, Days 1 & 8: 0 (pre-dose), & 2, 4, and 6 hours post-dose |
| Neuropathic Pain Symptom Inventory (NPSI) | NPSI: subject rated questionnaire to evaluate 5 dimensions of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia). Includes 10 descriptors ranging from 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each relevant dimension. Total score is calculated as the sum of scores of the 10 descriptors, range: 0-100. Higher score indicates greater intensity of pain. | Prior to morning dosing on Day 1 and prior to discharge on Day 8 for each period. |
| Pharmacokinetic Evaluations of Pregabalin | Pharmacokinetic (PK) results are not presented in this report due to early termination of the trial. Pregabalin PK was not measured as there was incomplete data to conduct pharmacokinetic/pharmacodynamic analyses. | Day 1: 0 (pre-dose), 0.5, 1, 2, and 6 hours post-dose; Day 8: 0 (pre-dose), 1, 4, & 6 hours post-dose |
| St Leonards |
| New South Wales |
| 2065 |
| Australia |
| Pfizer Investigational Site | Warrawong | New South Wales | 2502 | Australia |
| Pfizer Investigational Site | Heidelberg | Victoria | 3084 | Australia |
First Intervention Placebo Days 1-7: twice a day (BID); Day 8: 1 dose in the morning. Second Intervention Pregabalin: Days 1-7: 150 mg twice a day (BID); Day 8: 150 mg in the morning. |
| COMPLETED |
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| NOT COMPLETED |
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| Washout Period of 2 Weeks |
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| Second Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | Pregabalin: Days 1-7: 150 mg twice a day (BID); Day 8: 150 mg in the morning; and Placebo: Days 1-7: twice a day (BID); Day 8: 1 dose in the morning. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
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| Sex/Gender, Customized | Number | gender |
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| 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 | Present Pain Intensity Score | Present pain intensity score: 0-10 numeric rating scale (NRS), 0 (no pain) to 10 (worst possible pain). | Full analysis set (FAS): those subjects who completed both periods of the study. Combined results for At-level and Below-level neuropathic pain; At-level: located within 2 dermatomes above or below the level of spinal cord injury; Below-level: located at least 3 dermatomes below the level of spinal cord injury. | Posted | Mean | Standard Deviation | scores on scale | Day 1: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours (post-dose); Day 8: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours (post-dose) |
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| Secondary | Daily Pain Score | Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning. 0-10 numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain). | FAS; Combined results for At-level and Below-level of spinal cord injury. | Posted | Mean | Standard Deviation | scores on scale | Predose: Daily from 7 days before Visit 2 (start of Intervention 1) until the morning of Visit 5 (end of Intervention 2) |
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| Secondary | Dynamic Allodynia Area | Area of dynamic allodynia was assessed using a brush (SENSElab Brush 05; velocity approximately 20 millimeters per second [mm/s]) by stimulating along a pattern of 8 radial spokes. Stimulation was started from the non-painful perimetry. Subjects were asked to report change in sensation from non-painful to painful and the spot was marked onto the skin. The area of dynamic allodynia was determined from these 8 distances by calculating the area of an octagon (in centimeter squared [cm2]). | FAS; Combined results for At-level and Below-level of spinal cord injury. | Posted | Mean | Standard Deviation | cm2 | Screening, Days 1 & 8: 0 (pre-dose) & 4 hours post-dose, |
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| Secondary | Dynamic Allodynia Pain Score | Five strokes (each approx. 6 centimeters [cm] long) were applied with a standardized brush (SENSELab Brush 05) across the painful site (and a control site) at a constant velocity (20 millimeters per second [mm/sec]). Pain in response to brush stimulation of the allodynic area was recorded using an 11-point numeric rating scale from 0 (no pain) to 10 (worst possible pain). Patients were asked to give a pain rating after each brush stroke. A painful sensation was considered as representing brush allodynia. | FAS; Combined results for At-level and Below-level of spinal cord injury. | Posted | Mean | Standard Deviation | scores on scale | Screening, Days 1 & 8: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, and 6 hours post-dose |
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| Secondary | Punctate Allodynia Area | Area of punctate allodynia was determined using a von Frey filament (OptiHair2). Stimulation was started from the non-painful perimetry and repeated along a pattern of 8 radial spokes. With a movement along each spoke at steps of 5 millimeters (mm), the subjects reported sensation changes from non-painful to painful and the spot was marked on the skin. The area of punctate allodynia was determined from these 8 distances by calculating the area of an octagon (in square centimeter(s)[cm2]). | FAS; combined results for At-level and Below-level spinal cord injury. | Posted | Mean | Standard Deviation | cm2 | Screening, Days 1 & 8: 0 (pre-dose) and 4 hours post-dose |
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| Secondary | Mechanical Pain Sensitivity Stimulus-Response Function | Mechanical pain sensitivity stimulus response function was assessed at the control and painful sites using calibrated von Frey monofilaments and the SENSElab brush. Seven different von Frey monofilaments (8 -512 milliNewtons [mN], force increases by a factor of two from filament to filament) and the brush were applied in a predetermined pseudo-random order. Pain rating for each stimulus: 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst possible pain). | FAS; combined results for At-level and Below-level of spinal cord injury. | Posted | Mean | Standard Deviation | scores on scale | Screening, Days 1 & 8: 0 (pre-dose), & 2, 4, and 6 hours post-dose |
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| Secondary | Neuropathic Pain Symptom Inventory (NPSI) | NPSI: subject rated questionnaire to evaluate 5 dimensions of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia). Includes 10 descriptors ranging from 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each relevant dimension. Total score is calculated as the sum of scores of the 10 descriptors, range: 0-100. Higher score indicates greater intensity of pain. | FAS; Combined results for At-level and Below-level of spinal cord injury. | Posted | Median | Inter-Quartile Range | scores on scale | Prior to morning dosing on Day 1 and prior to discharge on Day 8 for each period. |
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| Secondary | Pharmacokinetic Evaluations of Pregabalin | Pharmacokinetic (PK) results are not presented in this report due to early termination of the trial. Pregabalin PK was not measured as there was incomplete data to conduct pharmacokinetic/pharmacodynamic analyses. | Not Posted | Day 1: 0 (pre-dose), 0.5, 1, 2, and 6 hours post-dose; Day 8: 0 (pre-dose), 1, 4, & 6 hours post-dose | Participants |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pregabalin | Days 1-7: 150 mg twice a day (BID); Day 8: 150 mg in the morning. | 0 | 15 | 12 | 15 | ||
| EG001 | Placebo | Days 1-7: twice a day (BID); Day 8: 1 dose in the morning. | 1 | 14 | 9 | 14 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Dermoid cyst | Congenital, familial and genetic disorders | MedDRA (11.1) | Systematic Assessment |
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| Eye pain | Eye disorders | MedDRA (11.1) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Catheter related complication | General disorders | MedDRA (11.1) | Systematic Assessment |
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| Chest pain | General disorders | MedDRA (11.1) | Systematic Assessment |
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| Chills | General disorders | MedDRA (11.1) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (11.1) | Systematic Assessment |
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| Feeling drunk | General disorders | MedDRA (11.1) | Systematic Assessment |
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| Feeling hot | General disorders | MedDRA (11.1) | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA (11.1) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (11.1) | Systematic Assessment |
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| Oral candidiasis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (11.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (11.1) | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA (11.1) | Systematic Assessment |
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| Urine analysis abnormal | Investigations | MedDRA (11.1) | Systematic Assessment |
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| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (11.1) | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
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| Dizziness postural | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
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| Lethargy | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
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| Muscle spasticity | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
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| Neuralgia | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
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| Tension headache | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
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| Euphoric mood | Psychiatric disorders | MedDRA (11.1) | Systematic Assessment |
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| Stress urinary incontinence | Renal and urinary disorders | MedDRA (11.1) | Systematic Assessment |
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| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
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This study was terminated prematurely.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.govCallCenter@pfizer.com |
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| 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 |
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| Title | Measurements |
|---|---|
|
| Day 1: 1 hours post-dose (n=15, 14) |
|
| Day 1: 2 hours post-dose (n=15, 14) |
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| Day 1: 3 hours post-dose (n=15, 14) |
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| Day 1: 4 hours post-dose (n=15, 14) |
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| Day 1: 5 hours post-dose (n=15, 14) |
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| Day 1: 6 hours post-dose (n=15, 14) |
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| Day 1: 8 hours post-dose (n=15, 14) |
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| Day 1: 10 hours post-dose (n=14, 14) |
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| Day 1: 12 hours post-dose (n=14, 14) |
|
| Day 8: pre-dose (n=13, 14) |
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| Day 8: 0.5 hours post-dose (n=13, 14) |
|
| Day 8: 1 hour post-dose (n=13, 14) |
|
| Day 8: 2 hours post-dose (n=13, 14) |
|
| Day 8: 3 hours post-dose (n=15, 14) |
|
| Day 8: 4 hours post-dose (n=15, 14) |
|
| Day 8: 5 hours post-dose (n=15, 14) |
|
| Day 8: 6 hours post-dose (n=15, 14) |
|
| Day 8: 8 hours post-dose (n=15, 13) |
|
| Day 8: 10 hours post-dose (n=15, 13) |
|
| Day 8: 12 hours post-dose (n=15, 13) |
|
| Day 8: 24 hours post-dose (n=15, 14) |
|
| Day 8: 36 hours post-dose (n=15, 13) |
|
| Day 8: 48 hours post-dose (n=15, 14) |
|
| ANOVA |
| 0.4811 |
| Mean Difference (Final Values) |
| -0.38 |
| Standard Error of the Mean |
| 0.528 |
| 95 |
| -1.54 |
| 0.77 |
| Superiority or Other (legacy) |
| Difference from placebo (including Baseline), Day 1: 2 hours post-dose. | ANOVA | 0.1693 | Mean Difference (Final Values) | -0.67 | Standard Error of the Mean | 0.454 | 95 | -1.67 | 0.33 | Superiority or Other (legacy) |
| Difference from placebo (including Baseline) , Day 1: 3 hours post-dose. | ANOVA | 0.4034 | Mean Difference (Final Values) | -0.45 | Standard Error of the Mean | 0.487 | 95 | -1.78 | 0.87 | Superiority or Other (legacy) |
| Difference from placebo (including Baseline), Day 1: 4 hours post-dose. | ANOVA | 0.1935 | Mean Difference (Final Values) | -0.93 | Standard Error of the Mean | 0.694 | 95 | -2.36 | 0.50 | Superiority or Other (legacy) |
| Difference from placebo (including Baseline), Day 1: 5 hours post-dose. | ANOVA | 0.0694 | Mean Difference (Final Values) | -1.36 | Standard Error of the Mean | 0.715 | 95 | -2.83 | 0.12 | Superiority or Other (legacy) |
| Difference from placebo (including Baseline), Day 1: 6 hours post-dose. | ANOVA | 0.0396 | Mean Difference (Final Values) | -1.55 | Standard Error of the Mean | 0.713 | 95 | -3.02 | -0.08 | Superiority or Other (legacy) |
| Difference from placebo (including Baseline), Day 1: 8 hours post-dose. | ANOVA | 0.1531 | Mean Difference (Final Values) | -0.51 | Standard Error of the Mean | 0.319 | 95 | -1.25 | 0.24 | Superiority or Other (legacy) |
| Difference from placebo (including Baseline), Day 1: 10 hours post-dose. | ANOVA | 0.0951 | Mean Difference (Final Values) | -1.25 | Standard Error of the Mean | 0.637 | 95 | -2.79 | 0.29 | Superiority or Other (legacy) |
| Difference from placebo (including Baseline), Day 1: 12 hours post-dose. | ANOVA | 0.0614 | Mean Difference (Final Values) | -1.38 | Standard Error of the Mean | 0.615 | 95 | -2.84 | 0.09 | Superiority or Other (legacy) |
| Difference from placebo (including Baseline), Day 8: pre-dose. | ANOVA | 0.1946 | Mean Difference (Final Values) | -0.87 | Standard Error of the Mean | 0.619 | 95 | -2.29 | 0.54 | Superiority or Other (legacy) |
| Difference from placebo (including Baseline), Day 8: 0.5 hours post-dose. | ANOVA | 0.2843 | Mean Difference (Final Values) | -0.68 | Standard Error of the Mean | 0.553 | 95 | -2.20 | 0.84 | Superiority or Other (legacy) |
| Difference from placebo (including Baseline), Day 8: 1 hour post-dose. | ANOVA | 0.2150 | Mean Difference (Final Values) | -1.05 | Standard Error of the Mean | 0.820 | 95 | -2.75 | 0.65 | Superiority or Other (legacy) |
| Difference from placebo (including Baseline), Day 8: 2 hours post-dose. | ANOVA | 0.9601 | Mean Difference (Final Values) | -0.01 | Standard Error of the Mean | 0.189 | 95 | -0.44 | 0.42 | Superiority or Other (legacy) |
| Difference from placebo (including baseline), Day 8: 3 hours post-dose. | ANOVA | 0.8670 | Mean Difference (Final Values) | 0.05 | Standard Error of the Mean | 0.311 | 95 | -0.64 | 0.74 | Superiority or Other (legacy) |
| Difference from placebo (including baseline), Day 8: 4 hours post-dose. | ANOVA | 0.9024 | Mean Difference (Final Values) | -0.05 | Standard Error of the Mean | 0.393 | 95 | -0.94 | 0.84 | Superiority or Other (legacy) |
| Difference from placebo (including Baseline), Day 8: 5 hours post-dose. | ANOVA | 0.9708 | Mean Difference (Final Values) | -0.01 | Standard Error of the Mean | 0.293 | 95 | -0.67 | 0.65 | Superiority or Other (legacy) |
| Difference from placebo (including Baseline), Day 8: 6 hours post-dose. | ANOVA | 0.1078 | Mean Difference (Final Values) | -0.71 | Standard Error of the Mean | 0.395 | 95 | -1.62 | 0.19 | Superiority or Other (legacy) |
| Difference from placebo (including Baseline), Day 8: 8 hours post-dose. | ANOVA | 0.4460 | Mean Difference (Final Values) | -0.33 | Standard Error of the Mean | 0.419 | 95 | -1.28 | 0.61 | Superiority or Other (legacy) |
| Difference from placebo (including Baseline), Day 8: 10 hours post-dose. | ANOVA | 0.5266 | Mean Difference (Final Values) | -0.26 | Standard Error of the Mean | 0.394 | 95 | -1.13 | 0.62 | Superiority or Other (legacy) |
| Difference from placebo (including Baseline), Day 8: 12 hours post-dose. | ANOVA | 0.0290 | Mean Difference (Final Values) | -0.69 | Standard Error of the Mean | 0.273 | 95 | -1.29 | -0.08 | Superiority or Other (legacy) |
| Difference from placebo (including Baseline), Day 8: 24 hours post-dose. | ANOVA | 0.1830 | Mean Difference (Final Values) | -0.78 | Standard Error of the Mean | 0.531 | 95 | -2.01 | 0.45 | Superiority or Other (legacy) |
| Difference from placebo (including Baseline), Day 8: 36 hours post-dose. | ANOVA | 0.9884 | Mean Difference (Final Values) | 0.01 | Standard Error of the Mean | 0.406 | 95 | -0.90 | 0.91 | Superiority or Other (legacy) |
| Difference from placebo (including Baseline), Day 8: 48 hours post-dose. | ANOVA | 0.8082 | Mean Difference (Final Values) | -0.09 | Standard Error of the Mean | 0.354 | 95 | -0.87 | 0.69 | Superiority or Other (legacy) |
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