Pain
Conditions
Keywords
Analgesic effect, Molar extraction
Brief summary
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.
Interventions
DRUGAZD1940
800ug oral administration
DRUGNaproxen
500mg oral administration
DRUGPlacebo
Placebo given pre-surgery
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients scheduled for surgical removal of one partial or complete impacted mandibular third molar. * Provision of signed informed consent. * Healthy males or non-fertile females.
Exclusion criteria
* History of somatic disease/condition, which may interfere with the objectives of the study, as judged by the investigator. * History of previous or ongoing psychiatric disease/condition including psychosis, affective disorder, anxiety disorder, borderline state and personality disorder according to the criteria in the Diagnostic and Statistical Manual of Mental Disorder, 4th edition.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Area Under the Curve 0-8h (AUC0-8h) | 0-8 h(from end of surgery to 8 hours post surgery) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Pain Based on VAS Scale | From end of surgery to 8h or time first intake of rescue medication (whichever came first) | 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) |
| Mean Pain Based on a VAS Scale | From end of surgery to 8h or time to first intake of rescue medication (whichever came first) | 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) |
| Pain at Jaw Movement AUC0-8h | 0-8h from end of surgery to 8 hours post surgery | 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) |
| Pain at Jaw Movement AUC0-4h | 0-4h after end of surgery to 4 hours post surgery | 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). |
| Maximum Pain at Jaw Movement | From end of surgery to 8h or time to first intake of rescue medication (whichever came first) | 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) |
| Mean Pain at Jaw Movement | From end of surgery to 8h or time to first intake of rescue medication (whichever came first) | 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 ). |
| Pain at Rescue Medication | At time of first rescue medication taken before 8 hours after end of surgery | 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). |
| Pain at Jaw Movement at Time of First Rescue Medication | At time of first rescue medication (before 8 hours after end on surgery) | 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). |
| Time to First Intake of Rescue Medication. | From end of surgery to 8 hours following surgery | — |
| Number of Patients Requesting Rescue Medication | End of surgery up to 8hours following surgery | Observed case. |
| Pain Area Under the VAS Versus Time Curve 0-4h (AUC0-4h) | 0-4h (from end of surgery to 4 hours post surgery) | 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. |
| Maximum Deterioration in VAMS High | Between dosing and 12h post-dose | 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. |
| Maximum Deterioration in VAMS Anxious | Between dosing and 12h post-dose | 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. |
| Maximum Deterioration in VAMS Sedated | Between dosing and 12h post-dose | 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. |
| Maximum Deterioration in VAMS Down | Between dosing and 12h post-dose | 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. |
| Time to Max Deterioration in VAMS Stimulated | Between dosing and 12h post-dose | 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. |
| Time to Max Deterioration in VAMS High | Between dosing and 12h post-dose | 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. |
| Time to Max Deterioration in VAMS Anxious | Between dosing and 12h post-dose | 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. |
| Time to Max Deterioration in VAMS Sedated | Between dosing and 12h post-dose | 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. |
| Time to Max Deterioration in VAMS Down | Between dosing and 12h post-dose | 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. |
| Maximum Deterioration in Visual Analogue Mood Scale (VAMS) Stimulated | Between dosing and 12h post-dose | 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. |
Countries
United States
Participant flow
Recruitment details
1 centre (Lifetree Clinical Research, Salt Lake City, Utah, USA) recruited between Feb and May 2008
Pre-assignment details
Screening for eligibility
Participants by arm
| Arm | Count |
|---|---|
| AZD1940 AZD1940 800ug given predose | 61 |
| Placebo Placebo given pre-surgery | 59 |
| Naproxen Naproxen 500mg given pre-surgery | 31 |
| Total | 151 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 0 | 1 |
Baseline characteristics
| Characteristic | AZD1940 | Placebo | Naproxen | Total |
|---|---|---|---|---|
| Age Continuous | 20.6 Years | 21.0 Years | 20.5 Years | 20.7 Years |
| Sex/Gender, Customized Unknown | 61 Participants | 59 Participants | 31 Participants | 151 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 3 / 61 | 2 / 59 | 0 / 31 |
| serious Total, serious adverse events | 0 / 61 | 0 / 59 | 0 / 31 |
Outcome results
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.
Time frame: 0-8 h(from end of surgery to 8 hours post surgery)
Population: The analyses based on a per-protocol population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD1940 | Pain Area Under the Curve 0-8h (AUC0-8h) | 355 mm*h | Standard Deviation 182.3 |
| Placebo | Pain Area Under the Curve 0-8h (AUC0-8h) | 356 mm*h | Standard Deviation 165.7 |
| Naproxen | Pain Area Under the Curve 0-8h (AUC0-8h) | 129 mm*h | Standard Deviation 105.4 |
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.
Time frame: Between dosing and 12h post-dose
Population: Only patients reporting a deterioration are included.The analyses are based on a per-protocol population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD1940 | Maximum Deterioration in VAMS Anxious | 20 mm | Standard Deviation 20 |
| Placebo | Maximum Deterioration in VAMS Anxious | 15 mm | Standard Deviation 13.1 |
| Naproxen | Maximum Deterioration in VAMS Anxious | 13 mm | Standard Deviation 15.1 |
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.
Time frame: Between dosing and 12h post-dose
Population: Only patients reporting a deterioration are included. The analyses are based on a per-protocol population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD1940 | Maximum Deterioration in VAMS Down | 20 mm | Standard Deviation 20.4 |
| Placebo | Maximum Deterioration in VAMS Down | 25 mm | Standard Deviation 23.5 |
| Naproxen | Maximum Deterioration in VAMS Down | 24 mm | Standard Deviation 29 |
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.
Time frame: Between dosing and 12h post-dose
Population: Only patients reporting a deterioration are included.The analyses are based on a per-protocol population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD1940 | Maximum Deterioration in VAMS High | 30 mm | Standard Deviation 25.2 |
| Placebo | Maximum Deterioration in VAMS High | 12 mm | Standard Deviation 7.5 |
| Naproxen | Maximum Deterioration in VAMS High | 20 mm | Standard Deviation 22.8 |
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.
Time frame: Between dosing and 12h post-dose
Population: Only patients reporting a deterioration are included.The analyses are based on a per-protocol population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD1940 | Maximum Deterioration in VAMS Sedated | 33 mm | Standard Deviation 24.8 |
| Placebo | Maximum Deterioration in VAMS Sedated | 21 mm | Standard Deviation 19.2 |
| Naproxen | Maximum Deterioration in VAMS Sedated | 24 mm | Standard Deviation 26.4 |
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.
Time frame: Between dosing and 12h post-dose
Population: Only patients reporting a deterioration are included.The analyses are based on a per-protocol population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD1940 | Maximum Deterioration in Visual Analogue Mood Scale (VAMS) Stimulated | 22 mm | Standard Deviation 15.1 |
| Placebo | Maximum Deterioration in Visual Analogue Mood Scale (VAMS) Stimulated | 26 mm | Standard Deviation 23.9 |
| Naproxen | Maximum Deterioration in Visual Analogue Mood Scale (VAMS) Stimulated | 28 mm | Standard Deviation 22.7 |
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)
Time frame: From end of surgery to 8h or time to first intake of rescue medication (whichever came first)
Population: The analyses based on a per-protocol population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD1940 | Maximum Pain at Jaw Movement | 63 mm | Standard Deviation 25.2 |
| Placebo | Maximum Pain at Jaw Movement | 63 mm | Standard Deviation 25.5 |
| Naproxen | Maximum Pain at Jaw Movement | 33 mm | Standard Deviation 24.7 |
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)
Time frame: From end of surgery to 8h or time first intake of rescue medication (whichever came first)
Population: The analyses based on a per-protocol population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD1940 | Maximum Pain Based on VAS Scale | 66 mm | Standard Deviation 24.5 |
| Placebo | Maximum Pain Based on VAS Scale | 65 mm | Standard Deviation 23.7 |
| Naproxen | Maximum Pain Based on VAS Scale | 33 mm | Standard Deviation 20.7 |
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 ).
Time frame: From end of surgery to 8h or time to first intake of rescue medication (whichever came first)
Population: The analyses based on a per-protocol population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD1940 | Mean Pain at Jaw Movement | 32 mm | Standard Deviation 20.9 |
| Placebo | Mean Pain at Jaw Movement | 28 mm | Standard Deviation 16.9 |
| Naproxen | Mean Pain at Jaw Movement | 14 mm | Standard Deviation 12.4 |
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)
Time frame: From end of surgery to 8h or time to first intake of rescue medication (whichever came first)
Population: The analyses based on a per-protocol population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD1940 | Mean Pain Based on a VAS Scale | 31 mm | Standard Deviation 19 |
| Placebo | Mean Pain Based on a VAS Scale | 29 mm | Standard Deviation 16.7 |
| Naproxen | Mean Pain Based on a VAS Scale | 13 mm | Standard Deviation 10.6 |
Secondary
Number of Patients Requesting Rescue Medication
Observed case.
Time frame: End of surgery up to 8hours following surgery
Population: The analyses are based on a per-protocol population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AZD1940 | Number of Patients Requesting Rescue Medication | 37 Participants |
| Placebo | Number of Patients Requesting Rescue Medication | 43 Participants |
| Naproxen | Number of Patients Requesting Rescue Medication | 7 Participants |
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.
Time frame: 0-4h (from end of surgery to 4 hours post surgery)
Population: The analyses based on a per-protocol population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD1940 | Pain Area Under the VAS Versus Time Curve 0-4h (AUC0-4h) | 145 mm*h | Standard Deviation 93.5 |
| Placebo | Pain Area Under the VAS Versus Time Curve 0-4h (AUC0-4h) | 143 mm*h | Standard Deviation 81.7 |
| Naproxen | Pain Area Under the VAS Versus Time Curve 0-4h (AUC0-4h) | 54 mm*h | Standard Deviation 45 |
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).
Time frame: At time of first rescue medication (before 8 hours after end on surgery)
Population: Only patients taking rescue are included in analysis. The analyses are based on a per-protocol population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD1940 | Pain at Jaw Movement at Time of First Rescue Medication | 67 mm | Standard Deviation 26.2 |
| Placebo | Pain at Jaw Movement at Time of First Rescue Medication | 65 mm | Standard Deviation 25.5 |
| Naproxen | Pain at Jaw Movement at Time of First Rescue Medication | 53 mm | Standard Deviation 15.4 |
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).
Time frame: 0-4h after end of surgery to 4 hours post surgery
Population: The analyses based on a per-protocol pop.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD1940 | Pain at Jaw Movement AUC0-4h | 142 mm*h | Standard Deviation 100.3 |
| Placebo | Pain at Jaw Movement AUC0-4h | 138 mm*h | Standard Deviation 86.9 |
| Naproxen | Pain at Jaw Movement AUC0-4h | 53 mm*h | Standard Deviation 47.5 |
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)
Time frame: 0-8h from end of surgery to 8 hours post surgery
Population: The analyses based on a per-protocol pop.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD1940 | Pain at Jaw Movement AUC0-8h | 342 mm*h | Standard Deviation 192 |
| Placebo | Pain at Jaw Movement AUC0-8h | 337 mm*h | Standard Deviation 170.5 |
| Naproxen | Pain at Jaw Movement AUC0-8h | 135 mm*h | Standard Deviation 119.7 |
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).
Time frame: At time of first rescue medication taken before 8 hours after end of surgery
Population: Only patients taking rescue are included in analysis. The analyses are based on a per-protocol population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD1940 | Pain at Rescue Medication | 73 mm | Standard Deviation 20.6 |
| Placebo | Pain at Rescue Medication | 70 mm | Standard Deviation 20.5 |
| Naproxen | Pain at Rescue Medication | 47 mm | Standard Deviation 13.8 |
Secondary
Time to First Intake of Rescue Medication.
Time frame: From end of surgery to 8 hours following surgery
Population: Only patients actually taking rescue medication are included in analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD1940 | Time to First Intake of Rescue Medication. | 3.8 Hours | Standard Deviation 1.05 |
| Placebo | Time to First Intake of Rescue Medication. | 3.7 Hours | Standard Deviation 1.16 |
| Naproxen | Time to First Intake of Rescue Medication. | 4.7 Hours | Standard Deviation 1.18 |
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.
Time frame: Between dosing and 12h post-dose
Population: Only patients reporting a deterioration are included.The analyses are based on a per-protocol population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD1940 | Time to Max Deterioration in VAMS Anxious | 126 minutes | Standard Deviation 88 |
| Placebo | Time to Max Deterioration in VAMS Anxious | 167 minutes | Standard Deviation 115.7 |
| Naproxen | Time to Max Deterioration in VAMS Anxious | 212 minutes | Standard Deviation 207.2 |
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.
Time frame: Between dosing and 12h post-dose
Population: Only patients reporting a deterioration are included.The analyses are based on a per-protocol population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD1940 | Time to Max Deterioration in VAMS Down | 227 minutes | Standard Deviation 156.2 |
| Placebo | Time to Max Deterioration in VAMS Down | 262 minutes | Standard Deviation 106.3 |
| Naproxen | Time to Max Deterioration in VAMS Down | 349 minutes | Standard Deviation 243.3 |
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.
Time frame: Between dosing and 12h post-dose
Population: Only patients reporting a deterioration are included.The analyses are based on a per-protocol population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD1940 | Time to Max Deterioration in VAMS High | 115 minutes | Standard Deviation 56.7 |
| Placebo | Time to Max Deterioration in VAMS High | 191 minutes | Standard Deviation 180 |
| Naproxen | Time to Max Deterioration in VAMS High | 193 minutes | Standard Deviation 125.9 |
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.
Time frame: Between dosing and 12h post-dose
Population: Only patients reporting a deterioration are included.The analyses are based on a per-protocol population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD1940 | Time to Max Deterioration in VAMS Sedated | 190 minutes | Standard Deviation 134.7 |
| Placebo | Time to Max Deterioration in VAMS Sedated | 221 minutes | Standard Deviation 134.5 |
| Naproxen | Time to Max Deterioration in VAMS Sedated | 227 minutes | Standard Deviation 150.5 |
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.
Time frame: Between dosing and 12h post-dose
Population: Only patients reporting a deterioration are included.The analyses are based on a per-protocol population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AZD1940 | Time to Max Deterioration in VAMS Stimulated | 143 Minutes | Standard Deviation 94.9 |
| Placebo | Time to Max Deterioration in VAMS Stimulated | 163 Minutes | Standard Deviation 108 |
| Naproxen | Time to Max Deterioration in VAMS Stimulated | 213 Minutes | Standard Deviation 190 |