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

5 giugno 2012 aggiornato da: AstraZeneca

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

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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

151

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Utah
      • Salt Lake City, Utah, Stati Uniti
        • Research Site

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 45 anni (Adulto)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: AZD1940
AZD1940 800ug given predose
Droga: AZD1940
800ug oral administration
Comparatore attivo: Naproxen
Naproxen 500mg given pre-surgery
Droga: Naproxen
500mg oral administration
Altri nomi:
  • Naprosina
Comparatore placebo: Placebo
Placebo given pre-surgery
Droga: Placebo
Placebo given pre-surgery

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Pain Area Under the Curve 0-8h (AUC0-8h)
Lasso di tempo: 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.
0-8 h(from end of surgery to 8 hours post surgery)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Pain Area Under the VAS Versus Time Curve 0-4h (AUC0-4h)
Lasso di tempo: 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.
0-4h (from end of surgery to 4 hours post surgery)
Maximum Pain Based on VAS Scale
Lasso di tempo: 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)
From end of surgery to 8h or time first intake of rescue medication (whichever came first)
Mean Pain Based on a VAS Scale
Lasso di tempo: 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)
From end of surgery to 8h or time to first intake of rescue medication (whichever came first)
Pain at Jaw Movement AUC0-8h
Lasso di tempo: 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)
0-8h from end of surgery to 8 hours post surgery
Pain at Jaw Movement AUC0-4h
Lasso di tempo: 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).
0-4h after end of surgery to 4 hours post surgery
Maximum Pain at Jaw Movement
Lasso di tempo: 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)
From end of surgery to 8h or time to first intake of rescue medication (whichever came first)
Mean Pain at Jaw Movement
Lasso di tempo: 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 ).
From end of surgery to 8h or time to first intake of rescue medication (whichever came first)
Pain at Rescue Medication
Lasso di tempo: 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).
At time of first rescue medication taken before 8 hours after end of surgery
Pain at Jaw Movement at Time of First Rescue Medication
Lasso di tempo: 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).
At time of first rescue medication (before 8 hours after end on surgery)
Time to First Intake of Rescue Medication.
Lasso di tempo: From end of surgery to 8 hours following surgery
From end of surgery to 8 hours following surgery
Number of Patients Requesting Rescue Medication
Lasso di tempo: End of surgery up to 8hours following surgery
Observed case.
End of surgery up to 8hours following surgery
Maximum Deterioration in Visual Analogue Mood Scale (VAMS) Stimulated
Lasso di tempo: 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.
Between dosing and 12h post-dose
Maximum Deterioration in VAMS High
Lasso di tempo: 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.
Between dosing and 12h post-dose
Maximum Deterioration in VAMS Anxious
Lasso di tempo: 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.
Between dosing and 12h post-dose
Maximum Deterioration in VAMS Sedated
Lasso di tempo: 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.
Between dosing and 12h post-dose
Maximum Deterioration in VAMS Down
Lasso di tempo: 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.
Between dosing and 12h post-dose
Time to Max Deterioration in VAMS Stimulated
Lasso di tempo: 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.
Between dosing and 12h post-dose
Time to Max Deterioration in VAMS High
Lasso di tempo: 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.
Between dosing and 12h post-dose
Time to Max Deterioration in VAMS Anxious
Lasso di tempo: 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.
Between dosing and 12h post-dose
Time to Max Deterioration in VAMS Sedated
Lasso di tempo: 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.
Between dosing and 12h post-dose
Time to Max Deterioration in VAMS Down
Lasso di tempo: 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.
Between dosing and 12h post-dose

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

AstraZeneca

Investigatori

  • Investigatore principale: Lynn Webster, MD, Lifetree Clinical Research3838 South, 700 East, Suite 202Salt Lake City, Utah 84106, USA
  • Cattedra di studio: Bror Jonzon, AstraZeneca R&D Södertälje, SE-151 85 Södertälje, Sweden

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 febbraio 2008

Completamento primario (Effettivo)

1 maggio 2008

Completamento dello studio (Effettivo)

1 maggio 2008

Date di iscrizione allo studio

Primo inviato

10 aprile 2008

Primo inviato che soddisfa i criteri di controllo qualità

15 aprile 2008

Primo Inserito (Stima)

16 aprile 2008

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

11 giugno 2012

Ultimo aggiornamento inviato che soddisfa i criteri QC

5 giugno 2012

Ultimo verificato

1 maggio 2010

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • D3120C00006

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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