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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00659490
First received: April 10, 2008
Last updated: June 5, 2012
Last verified: May 2010
  Purpose

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.


Condition Intervention Phase
Pain
Drug: AZD1940
Drug: Naproxen
Drug: Placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Pain Area Under the Curve 0-8h (AUC0-8h) [ Time Frame: 0-8 h(from end of surgery to 8 hours post surgery) ] [ Designated as safety issue: No ]
    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:
  • Pain Area Under the VAS Versus Time Curve 0-4h (AUC0-4h) [ Time Frame: 0-4h (from end of surgery to 4 hours post surgery) ] [ Designated as safety issue: No ]
    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 [ Time Frame: From end of surgery to 8h or time first intake of rescue medication (whichever came first) ] [ Designated as safety issue: No ]

    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 [ Time Frame: From end of surgery to 8h or time to first intake of rescue medication (whichever came first) ] [ Designated as safety issue: No ]
    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 [ Time Frame: 0-8h from end of surgery to 8 hours post surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: 0-4h after end of surgery to 4 hours post surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: From end of surgery to 8h or time to first intake of rescue medication (whichever came first) ] [ Designated as safety issue: No ]

    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 [ Time Frame: From end of surgery to 8h or time to first intake of rescue medication (whichever came first) ] [ Designated as safety issue: No ]
    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 [ Time Frame: At time of first rescue medication taken before 8 hours after end of surgery ] [ Designated as safety issue: No ]

    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 [ Time Frame: At time of first rescue medication (before 8 hours after end on surgery) ] [ Designated as safety issue: No ]

    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. [ Time Frame: From end of surgery to 8 hours following surgery ] [ Designated as safety issue: No ]
  • Number of Patients Requesting Rescue Medication [ Time Frame: End of surgery up to 8hours following surgery ] [ Designated as safety issue: No ]
    Observed case.

  • Maximum Deterioration in Visual Analogue Mood Scale (VAMS) Stimulated [ Time Frame: Between dosing and 12h post-dose ] [ Designated as safety issue: No ]
    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 [ Time Frame: Between dosing and 12h post-dose ] [ Designated as safety issue: No ]
    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 [ Time Frame: Between dosing and 12h post-dose ] [ Designated as safety issue: No ]
    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 [ Time Frame: Between dosing and 12h post-dose ] [ Designated as safety issue: No ]
    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 [ Time Frame: Between dosing and 12h post-dose ] [ Designated as safety issue: No ]
    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 [ Time Frame: Between dosing and 12h post-dose ] [ Designated as safety issue: No ]
    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 [ Time Frame: Between dosing and 12h post-dose ] [ Designated as safety issue: No ]
    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 [ Time Frame: Between dosing and 12h post-dose ] [ Designated as safety issue: No ]
    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 [ Time Frame: Between dosing and 12h post-dose ] [ Designated as safety issue: No ]
    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 [ Time Frame: Between dosing and 12h post-dose ] [ Designated as safety issue: No ]
    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.


Enrollment: 151
Study Start Date: February 2008
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AZD1940
AZD1940 800ug given predose
Drug: AZD1940
800ug oral administration
Active Comparator: Naproxen
Naproxen 500mg given pre-surgery
Drug: Naproxen
500mg oral administration
Other Name: Naprosyn
Placebo Comparator: Placebo
Placebo given pre-surgery
Drug: Placebo
Placebo given pre-surgery

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00659490

Locations
United States, Utah
Research Site
Salt Lake City, Utah, United States
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Lynn Webster, MD Lifetree Clinical Research3838 South, 700 East, Suite 202Salt Lake City, Utah 84106, USA
Study Chair: Bror Jonzon AstraZeneca R&D Södertälje, SE-151 85 Södertälje, Sweden
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00659490     History of Changes
Other Study ID Numbers: D3120C00006
Study First Received: April 10, 2008
Results First Received: May 4, 2010
Last Updated: June 5, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Analgesic effect
Molar extraction

Additional relevant MeSH terms:
Analgesics
Naproxen
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 24, 2014