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Completed

NCT Number: NCT00659490

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

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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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site

Salt Lake City, Utah, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AZD1940

Drug

800ug oral administration

Naproxen

Drug

500mg oral administration

Other names: Naprosyn

Placebo

Drug

Placebo given pre-surgery

Primary outcomes

  1. Pain Area Under the Curve 0-8h (AUC0-8h)

    Time frame: 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 outcomes

  1. 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)

    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.

  2. Maximum Pain Based on VAS Scale

    Time frame: 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)

  3. 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)

    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)

  4. Pain at Jaw Movement AUC0-8h

    Time frame: 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)

  5. Pain at Jaw Movement AUC0-4h

    Time frame: 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).

  6. Maximum Pain at Jaw Movement

    Time frame: 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)

  7. Mean Pain at Jaw Movement

    Time frame: 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 ).

  8. Pain at Rescue Medication

    Time frame: 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).

  9. 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)

    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).

  10. Time to First Intake of Rescue Medication.

    Time frame: From end of surgery to 8 hours following surgery

  11. Number of Patients Requesting Rescue Medication

    Time frame: End of surgery up to 8hours following surgery

    Observed case.

  12. Maximum Deterioration in Visual Analogue Mood Scale (VAMS) Stimulated

    Time frame: 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.

  13. Maximum Deterioration in VAMS High

    Time frame: 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.

  14. Maximum Deterioration in VAMS Anxious

    Time frame: 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.

  15. Maximum Deterioration in VAMS Sedated

    Time frame: 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.

  16. Maximum Deterioration in VAMS Down

    Time frame: 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.

  17. Time to Max Deterioration in VAMS Stimulated

    Time frame: 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.

  18. Time to Max Deterioration in VAMS High

    Time frame: 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.

  19. Time to Max Deterioration in VAMS Anxious

    Time frame: 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.

  20. Time to Max Deterioration in VAMS Sedated

    Time frame: 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.

  21. Time to Max Deterioration in VAMS Down

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Apr 16, 2008
Registry last updated
Jun 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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