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

Pain Clinical Trial

Official title:

A Randomised, Double Blind, Placebo-Controlled Study to Investigate the Analgesic Efficacy of a Single Dose of AZD1940, in Patients Undergoing Impacted Mandibular Third Molar Extraction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00659490
• Other study ID #: D3120C00006
• Status: Completed
• Phase: Phase 2
• First received: April 10, 2008
• Last updated: June 5, 2012
• Start date: February 2008
• Est. completion date: May 2008

Study information

• Verified date: May 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• AZD1940
800ug oral administration
• Naproxen
500mg oral administration
• Placebo
Placebo given pre-surgery

Locations

Country	Name	City	State
United States	Research Site	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	0-8 h(from end of surgery to 8 hours post surgery)	No
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.	0-4h (from end of surgery to 4 hours post surgery)	No
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)	From end of surgery to 8h or time first intake of rescue medication (whichever came first)	No
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)	From end of surgery to 8h or time to first intake of rescue medication (whichever came first)	No
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)	0-8h from end of surgery to 8 hours post surgery	No
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).	0-4h after end of surgery to 4 hours post surgery	No
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)	From end of surgery to 8h or time to first intake of rescue medication (whichever came first)	No
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 ).	From end of surgery to 8h or time to first intake of rescue medication (whichever came first)	No
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).	At time of first rescue medication taken before 8 hours after end of surgery	No
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).	At time of first rescue medication (before 8 hours after end on surgery)	No
Secondary	Time to First Intake of Rescue Medication.		From end of surgery to 8 hours following surgery	No
Secondary	Number of Patients Requesting Rescue Medication	Observed case.	End of surgery up to 8hours following surgery	No
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.	Between dosing and 12h post-dose	No
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.	Between dosing and 12h post-dose	No
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.	Between dosing and 12h post-dose	No
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.	Between dosing and 12h post-dose	No
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.	Between dosing and 12h post-dose	No
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.	Between dosing and 12h post-dose	No
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.	Between dosing and 12h post-dose	No
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.	Between dosing and 12h post-dose	No
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.	Between dosing and 12h post-dose	No
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.	Between dosing and 12h post-dose	No