Study to Investigate the Analgesic Efficacy of a Single Dose of AZD1940

Phase 2

Completed

Conditions: Pain

Interventions: Drug: AZD1940
Drug: Placebo
Drug: Naproxen

Registration Number: NCT00659490

Lead Sponsor: AstraZeneca

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 151

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AZD1940	AZD1940	AZD1940 800ug given predose
Placebo	Placebo	Placebo given pre-surgery
Naproxen	Naproxen	Naproxen 500mg given pre-surgery

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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.
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.
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.