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The primary aim of this study is to investigate if AZD1940 can relieve the pain induced by the surgical removal of one lower wisdom-tooth. This will be done by comparing the effect of AZD1940 to placebo ("inactive substance") on pain. A number of patients will instead receive the common painkiller naproxen for comparison purposes. Rescue medication, acetaminophen, will be allowed if a need for additional painkillers would arise. A number of patients will receive Naproxen as control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD1940 | Experimental | AZD1940 800ug given predose |
|
| Naproxen | Active Comparator | Naproxen 500mg given pre-surgery |
|
| Placebo | Placebo Comparator | Placebo given pre-surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD1940 | Drug | 800ug oral administration |
| |
| Naproxen |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Area Under the Curve 0-8h (AUC0-8h) | Area under the Visual Analogue Scale (VAS, 0-100 mm) time curve 0-8h (from end of surgery). Missing values in the pain-by-time curve was imputated using linear interpolation, last observation carried forward (LOCF) or first observation carried backwards (FOCB) as applicable. | 0-8 h(from end of surgery to 8 hours post surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Area Under the VAS Versus Time Curve 0-4h (AUC0-4h) | Area under the Visual Analogue Scale (VAS, 0-100 mm) time curve 0-4h (from end of surgery). Missing values in the pain-by-time curve was imputated using linear interpolation, last observation carried forward (LOCF) or first observation carried backwards (FOCB) as applicable. | 0-4h (from end of surgery to 4 hours post surgery) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lynn Webster, MD | Lifetree Clinical Research3838 South, 700 East, Suite 202Salt Lake City, Utah 84106, USA | Principal Investigator |
| Bror Jonzon | AstraZeneca R&D Södertälje, SE-151 85 Södertälje, Sweden | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Salt Lake City | Utah | United States |
Screening for eligibility
1 centre (Lifetree Clinical Research, Salt Lake City, Utah, USA) recruited between Feb and May 2008
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | AZD1940 | AZD1940 800ug given predose |
| FG001 | Placebo | Placebo given pre-surgery |
| FG002 | Naproxen | Naproxen 500mg given pre-surgery |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | AZD1940 | AZD1940 800ug given predose |
| BG001 | Placebo | Placebo given pre-surgery |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 | Pain Area Under the Curve 0-8h (AUC0-8h) | Area under the Visual Analogue Scale (VAS, 0-100 mm) time curve 0-8h (from end of surgery). Missing values in the pain-by-time curve was imputated using linear interpolation, last observation carried forward (LOCF) or first observation carried backwards (FOCB) as applicable. | The analyses based on a per-protocol population. | Posted | Mean | Standard Deviation | mm*h | 0-8 h(from end of surgery to 8 hours post surgery) |
|
Not provided
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 | AZD1940 | AZD1940 800ug given predose |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Presyncope, Syncope | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | aztrial_results_posting@astrazeneca.com |
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C582877 | N-(2-tert-butyl-1-((4,4-difluorocyclohexyl)methyl)-1H-benzo(d)imidazol-5-yl)ethanesulfonamide |
| D009288 | Naproxen |
| ID | Term |
|---|---|
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
Not provided
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| Drug |
500mg oral administration |
|
|
| Placebo | Drug | Placebo given pre-surgery |
|
| Maximum Pain Based on VAS Scale | Maximum pain recorded on a Visual Analogue Scale, VAS (0-100mm). Observed case. Maximum pain VAS (0-100mm, 0 = no pain - 100 = worst pain imaginable) | From end of surgery to 8h or time first intake of rescue medication (whichever came first) |
| Mean Pain Based on a VAS Scale | Calculated as the area under the Visual Analogue Pain Scale (0-100 mm) versus time curve divided by time.Missing values in the pain-by-time curve was imputated using linear interpolation, last observation carried forward (LOCF) or first observation carried backwards (FOCB) as applicable. Mean pain VAS (0-100mm, 0 = no pain - 100 = worst pain imaginable) | From end of surgery to 8h or time to first intake of rescue medication (whichever came first) |
| Pain at Jaw Movement AUC0-8h | Area under the Visual Analogue Scale (VAS, 0-100 mm) of jaw movement versus time curve 0-8h (from end of surgery). Missing values in the pain-by-time curve was imputated using linear interpolation, last observation carried forward (LOCF) or first observation carried backwards (FOCB) as applicable. Area under the curve 0-8h (from end of surgery) of VAS pain at jaw movement (0-100mm, 0 = no pain - 100 = worst pain imaginable) | 0-8h from end of surgery to 8 hours post surgery |
| Pain at Jaw Movement AUC0-4h | Area under the Visual Analogue Scale (VAS, 0-100 mm) of jaw movement versus time curve 0-4h (from end of surgery). Missing values in the pain-by-time curve was imputated using linear interpolation, last observation carried forward (LOCF) or first observation carried backwards (FOCB) as applicable. Area under the curve 0-4h (from end of surgery) of VAS pain at jaw movement (0-100mm0 = no pain - 100 = worst pain imaginable). | 0-4h after end of surgery to 4 hours post surgery |
| Maximum Pain at Jaw Movement | Maximum pain at jaw movement recorded on a Visual Analogue Scale, VAS (0-100mm). Observed case. Maximum Pain at jaw movement VAS (0-100mm, 0 = no pain - 100 = worst pain imaginable) | From end of surgery to 8h or time to first intake of rescue medication (whichever came first) |
| Mean Pain at Jaw Movement | Calculated as the area under the Visual Analogue Pain Scale (0-100 mm) of jaw movement versus time curve divided by time. Missing values in the pain-by-time curve was imputated using linear interpolation, last observation carried forward (LOCF) or first observation carried backwards (FOCB) as applicable. Mean Pain at jaw movement VAS (0-100mm, 0 = no pain - 100 = worst pain imaginable ). | From end of surgery to 8h or time to first intake of rescue medication (whichever came first) |
| Pain at Rescue Medication | Pain at time of first rescue medication (VAS 0-100mm). Only patients taking rescue are included in analysis. Observed case. Pain at time of first rescue medication (VAS 0-100mm, 0 = no pain - 100 = worst pain imaginable). | At time of first rescue medication taken before 8 hours after end of surgery |
| Pain at Jaw Movement at Time of First Rescue Medication | Pain at jaw movement at time of first rescue medication (VAS 0-100mm). Observed case. Pain at jaw movement at time of first rescue medication (VAS 0-100mm, 0 = no pain - 100 = worst pain imaginable). | At time of first rescue medication (before 8 hours after end on surgery) |
| Time to First Intake of Rescue Medication. | From end of surgery to 8 hours following surgery |
| Number of Patients Requesting Rescue Medication | Observed case. | End of surgery up to 8hours following surgery |
| Maximum Deterioration in Visual Analogue Mood Scale (VAMS) Stimulated | Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from 'not at all' on the left end of the scale to 'extremely' on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry. | Between dosing and 12h post-dose |
| Maximum Deterioration in VAMS High | Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from 'not at all' on the left end of the scale to 'extremely' on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry. | Between dosing and 12h post-dose |
| Maximum Deterioration in VAMS Anxious | Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from 'not at all' on the left end of the scale to 'extremely' on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry. | Between dosing and 12h post-dose |
| Maximum Deterioration in VAMS Sedated | Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from 'not at all' on the left end of the scale to 'extremely' on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry. | Between dosing and 12h post-dose |
| Maximum Deterioration in VAMS Down | Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from 'not at all' on the left end of the scale to 'extremely' on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry. | Between dosing and 12h post-dose |
| Time to Max Deterioration in VAMS Stimulated | Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from 'not at all' on the left end of the scale to 'extremely' on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry. | Between dosing and 12h post-dose |
| Time to Max Deterioration in VAMS High | Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from 'not at all' on the left end of the scale to 'extremely' on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry. | Between dosing and 12h post-dose |
| Time to Max Deterioration in VAMS Anxious | Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from 'not at all' on the left end of the scale to 'extremely' on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry. | Between dosing and 12h post-dose |
| Time to Max Deterioration in VAMS Sedated | Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from 'not at all' on the left end of the scale to 'extremely' on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry. | Between dosing and 12h post-dose |
| Time to Max Deterioration in VAMS Down | Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from 'not at all' on the left end of the scale to 'extremely' on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry. | Between dosing and 12h post-dose |
| BG002 |
| Naproxen |
Naproxen 500mg given pre-surgery |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex/Gender, Customized | Number | Participants |
|
| OG002 |
| Naproxen |
Naproxen 500mg given pre-surgery |
|
|
| Secondary | Pain Area Under the VAS Versus Time Curve 0-4h (AUC0-4h) | Area under the Visual Analogue Scale (VAS, 0-100 mm) time curve 0-4h (from end of surgery). Missing values in the pain-by-time curve was imputated using linear interpolation, last observation carried forward (LOCF) or first observation carried backwards (FOCB) as applicable. | The analyses based on a per-protocol population. | Posted | Mean | Standard Deviation | mm*h | 0-4h (from end of surgery to 4 hours post surgery) |
|
|
|
| Secondary | Maximum Pain Based on VAS Scale | Maximum pain recorded on a Visual Analogue Scale, VAS (0-100mm). Observed case. Maximum pain VAS (0-100mm, 0 = no pain - 100 = worst pain imaginable) | The analyses based on a per-protocol population. | Posted | Mean | Standard Deviation | mm | From end of surgery to 8h or time first intake of rescue medication (whichever came first) |
|
|
|
| Secondary | Mean Pain Based on a VAS Scale | Calculated as the area under the Visual Analogue Pain Scale (0-100 mm) versus time curve divided by time.Missing values in the pain-by-time curve was imputated using linear interpolation, last observation carried forward (LOCF) or first observation carried backwards (FOCB) as applicable. Mean pain VAS (0-100mm, 0 = no pain - 100 = worst pain imaginable) | The analyses based on a per-protocol population. | Posted | Mean | Standard Deviation | mm | From end of surgery to 8h or time to first intake of rescue medication (whichever came first) |
|
|
|
| Secondary | Pain at Jaw Movement AUC0-8h | Area under the Visual Analogue Scale (VAS, 0-100 mm) of jaw movement versus time curve 0-8h (from end of surgery). Missing values in the pain-by-time curve was imputated using linear interpolation, last observation carried forward (LOCF) or first observation carried backwards (FOCB) as applicable. Area under the curve 0-8h (from end of surgery) of VAS pain at jaw movement (0-100mm, 0 = no pain - 100 = worst pain imaginable) | The analyses based on a per-protocol pop. | Posted | Mean | Standard Deviation | mm*h | 0-8h from end of surgery to 8 hours post surgery |
|
|
|
| Secondary | Pain at Jaw Movement AUC0-4h | Area under the Visual Analogue Scale (VAS, 0-100 mm) of jaw movement versus time curve 0-4h (from end of surgery). Missing values in the pain-by-time curve was imputated using linear interpolation, last observation carried forward (LOCF) or first observation carried backwards (FOCB) as applicable. Area under the curve 0-4h (from end of surgery) of VAS pain at jaw movement (0-100mm0 = no pain - 100 = worst pain imaginable). | The analyses based on a per-protocol pop. | Posted | Mean | Standard Deviation | mm*h | 0-4h after end of surgery to 4 hours post surgery |
|
|
|
| Secondary | Maximum Pain at Jaw Movement | Maximum pain at jaw movement recorded on a Visual Analogue Scale, VAS (0-100mm). Observed case. Maximum Pain at jaw movement VAS (0-100mm, 0 = no pain - 100 = worst pain imaginable) | The analyses based on a per-protocol population. | Posted | Mean | Standard Deviation | mm | From end of surgery to 8h or time to first intake of rescue medication (whichever came first) |
|
|
|
| Secondary | Mean Pain at Jaw Movement | Calculated as the area under the Visual Analogue Pain Scale (0-100 mm) of jaw movement versus time curve divided by time. Missing values in the pain-by-time curve was imputated using linear interpolation, last observation carried forward (LOCF) or first observation carried backwards (FOCB) as applicable. Mean Pain at jaw movement VAS (0-100mm, 0 = no pain - 100 = worst pain imaginable ). | The analyses based on a per-protocol population. | Posted | Mean | Standard Deviation | mm | From end of surgery to 8h or time to first intake of rescue medication (whichever came first) |
|
|
|
| Secondary | Pain at Rescue Medication | Pain at time of first rescue medication (VAS 0-100mm). Only patients taking rescue are included in analysis. Observed case. Pain at time of first rescue medication (VAS 0-100mm, 0 = no pain - 100 = worst pain imaginable). | Only patients taking rescue are included in analysis. The analyses are based on a per-protocol population. | Posted | Mean | Standard Deviation | mm | At time of first rescue medication taken before 8 hours after end of surgery |
|
|
|
| Secondary | Pain at Jaw Movement at Time of First Rescue Medication | Pain at jaw movement at time of first rescue medication (VAS 0-100mm). Observed case. Pain at jaw movement at time of first rescue medication (VAS 0-100mm, 0 = no pain - 100 = worst pain imaginable). | Only patients taking rescue are included in analysis. The analyses are based on a per-protocol population. | Posted | Mean | Standard Deviation | mm | At time of first rescue medication (before 8 hours after end on surgery) |
|
|
|
| Secondary | Time to First Intake of Rescue Medication. | Only patients actually taking rescue medication are included in analysis. | Posted | Mean | Standard Deviation | Hours | From end of surgery to 8 hours following surgery |
|
|
|
| Secondary | Number of Patients Requesting Rescue Medication | Observed case. | The analyses are based on a per-protocol population. | Posted | Number | Participants | End of surgery up to 8hours following surgery |
|
|
|
| Secondary | Maximum Deterioration in Visual Analogue Mood Scale (VAMS) Stimulated | Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from 'not at all' on the left end of the scale to 'extremely' on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry. | Only patients reporting a deterioration are included.The analyses are based on a per-protocol population. | Posted | Mean | Standard Deviation | mm | Between dosing and 12h post-dose |
|
|
|
| Secondary | Maximum Deterioration in VAMS High | Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from 'not at all' on the left end of the scale to 'extremely' on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry. | Only patients reporting a deterioration are included.The analyses are based on a per-protocol population. | Posted | Mean | Standard Deviation | mm | Between dosing and 12h post-dose |
|
|
|
| Secondary | Maximum Deterioration in VAMS Anxious | Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from 'not at all' on the left end of the scale to 'extremely' on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry. | Only patients reporting a deterioration are included.The analyses are based on a per-protocol population. | Posted | Mean | Standard Deviation | mm | Between dosing and 12h post-dose |
|
|
|
| Secondary | Maximum Deterioration in VAMS Sedated | Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from 'not at all' on the left end of the scale to 'extremely' on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry. | Only patients reporting a deterioration are included.The analyses are based on a per-protocol population. | Posted | Mean | Standard Deviation | mm | Between dosing and 12h post-dose |
|
|
|
| Secondary | Maximum Deterioration in VAMS Down | Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from 'not at all' on the left end of the scale to 'extremely' on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry. | Only patients reporting a deterioration are included. The analyses are based on a per-protocol population. | Posted | Mean | Standard Deviation | mm | Between dosing and 12h post-dose |
|
|
|
| Secondary | Time to Max Deterioration in VAMS Stimulated | Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from 'not at all' on the left end of the scale to 'extremely' on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry. | Only patients reporting a deterioration are included.The analyses are based on a per-protocol population. | Posted | Mean | Standard Deviation | Minutes | Between dosing and 12h post-dose |
|
|
|
| Secondary | Time to Max Deterioration in VAMS High | Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from 'not at all' on the left end of the scale to 'extremely' on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry. | Only patients reporting a deterioration are included.The analyses are based on a per-protocol population. | Posted | Mean | Standard Deviation | minutes | Between dosing and 12h post-dose |
|
|
|
| Secondary | Time to Max Deterioration in VAMS Anxious | Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from 'not at all' on the left end of the scale to 'extremely' on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry. | Only patients reporting a deterioration are included.The analyses are based on a per-protocol population. | Posted | Mean | Standard Deviation | minutes | Between dosing and 12h post-dose |
|
|
|
| Secondary | Time to Max Deterioration in VAMS Sedated | Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from 'not at all' on the left end of the scale to 'extremely' on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry. | Only patients reporting a deterioration are included.The analyses are based on a per-protocol population. | Posted | Mean | Standard Deviation | minutes | Between dosing and 12h post-dose |
|
|
|
| Secondary | Time to Max Deterioration in VAMS Down | Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from 'not at all' on the left end of the scale to 'extremely' on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry. | Only patients reporting a deterioration are included.The analyses are based on a per-protocol population. | Posted | Mean | Standard Deviation | minutes | Between dosing and 12h post-dose |
|
|
|
| 0 |
| 61 |
| 3 |
| 61 |
| EG001 | Placebo | Placebo given pre-surgery | 0 | 59 | 2 | 59 |
| EG002 | Naproxen | Naproxen 500mg given pre-surgery | 0 | 31 | 0 | 31 |
AstraZeneca has exclusive rights to publish the results of the tudy
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |