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A 10-Week Study Evaluating the Efficacy And Safety of PD 0332334 for the Treatment of Generalized Anxiety Disorder

9. november 2012 opdateret af: Pfizer

A Phase 3, Randomized, Double-Blind, Placebo Controlled, Parallel Group, 10-Week Study Evaluating the Efficacy And Safety of PD 0332334 for the Treatment of Generalized Anxiety Disorder

This study will evaluate the efficacy and safety of PD 0332334 for the treatment of generalized anxiety disorder.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

551

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • Beverly Hills, California, Forenede Stater, 90210
        • Pfizer Investigational Site
      • Encino, California, Forenede Stater, 91316
        • Pfizer Investigational Site
      • National City, California, Forenede Stater, 91950
        • Pfizer Investigational Site
      • Newport Beach, California, Forenede Stater, 92660-2452
        • Pfizer Investigational Site
      • San Diego, California, Forenede Stater, 92103
        • Pfizer Investigational Site
      • Sherman Oaks, California, Forenede Stater, 91403
        • Pfizer Investigational Site
    • Connecticut
      • Farmington, Connecticut, Forenede Stater, 06030-6415
        • Pfizer Investigational Site
    • Florida
      • Jacksonville, Florida, Forenede Stater, 32216
        • Pfizer Investigational Site
      • Jacksonville, Florida, Forenede Stater, 32256-2006
        • Pfizer Investigational Site
      • Orlando, Florida, Forenede Stater, 32806
        • Pfizer Investigational Site
      • Tampa, Florida, Forenede Stater, 33613
        • Pfizer Investigational Site
      • West Palm Beach, Florida, Forenede Stater, 33407
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30308
        • Pfizer Investigational Site
      • Atlanta, Georgia, Forenede Stater, 30328
        • Pfizer Investigational Site
      • Marietta, Georgia, Forenede Stater, 30060
        • Pfizer Investigational Site
    • Illinois
      • Libertyville, Illinois, Forenede Stater, 60048
        • Pfizer Investigational Site
      • Schaumburg, Illinois, Forenede Stater, 60194
        • Pfizer Investigational Site
    • Indiana
      • Lafayette, Indiana, Forenede Stater, 47905
        • Pfizer Investigational Site
    • Kentucky
      • Owensboro, Kentucky, Forenede Stater, 42301
        • Pfizer Investigational Site
    • Louisiana
      • Lake Charles, Louisiana, Forenede Stater, 70601
        • Pfizer Investigational Site
    • Maryland
      • Glen Burnie, Maryland, Forenede Stater, 21061
        • Pfizer Investigational Site
      • Rockville, Maryland, Forenede Stater, 20852
        • Pfizer Investigational Site
    • Massachusetts
      • Belmont, Massachusetts, Forenede Stater, 02478
        • Pfizer Investigational Site
      • Fall River, Massachusetts, Forenede Stater, 02721
        • Pfizer Investigational Site
    • Michigan
      • Farmington Hills, Michigan, Forenede Stater, 48336
        • Pfizer Investigational Site
    • New Hampshire
      • Nashua, New Hampshire, Forenede Stater, 03060
        • Pfizer Investigational Site
    • New Jersey
      • Cherry Hill, New Jersey, Forenede Stater, 08002
        • Pfizer Investigational Site
      • Piscataway, New Jersey, Forenede Stater, 08854-5635
        • Pfizer Investigational Site
    • New York
      • Brooklyn, New York, Forenede Stater, 11201
        • Pfizer Investigational Site
      • New York, New York, Forenede Stater, 10024
        • Pfizer Investigational Site
      • Staten Island, New York, Forenede Stater, 10312
        • Pfizer Investigational Site
    • North Carolina
      • Chapel Hill, North Carolina, Forenede Stater, 27514
        • Pfizer Investigational Site
      • Durham, North Carolina, Forenede Stater, 27710
        • Pfizer Investigational Site
    • Ohio
      • Columbus, Ohio, Forenede Stater, 43210
        • Pfizer Investigational Site
    • Oregon
      • Portland, Oregon, Forenede Stater, 97210
        • Pfizer Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19149
        • Pfizer Investigational Site
      • Philadelphia, Pennsylvania, Forenede Stater, 19139
        • Pfizer Investigational Site
    • Rhode Island
      • Lincoln, Rhode Island, Forenede Stater, 02865
        • Pfizer Investigational Site
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29407
        • Pfizer Investigational Site
    • Texas
      • Houston, Texas, Forenede Stater, 77057
        • Pfizer Investigational Site
    • Virginia
      • Richmond, Virginia, Forenede Stater, 23230
        • Pfizer Investigational Site
    • Washington
      • Seattle, Washington, Forenede Stater, 98104
        • Pfizer Investigational Site
    • Wisconsin
      • Middleton, Wisconsin, Forenede Stater, 53562
        • Pfizer Investigational Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Diagnosis of GAD (Diagnostic and Statistical Manual-IV [DSM-IV], 300.02) as established by the clinician (psychiatrist or licensed clinical psychologist) who has interviewed the subject using all sources of data including the Mini International Neuropsychiatric Interview (MINI) for DSM-IV Axis I disorders and other clinical information. Subjects with specific phobia(s) (as defined in DSM-IV) or dysthymic disorder will be allowed in the study.
  • Subjects must have a HAM-A total score ≥20 at the screening (V1) and randomization (V2) visits. Subjects must also have a Covi Anxiety Scale score of >9 and a Raskin Depression Scale score <7 at the Screening (V1) visit to ensure predominance of anxiety symptoms over depression symptoms.

Exclusion Criteria:

  • Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, pancreatic, neurologic, active infections, immunological, or allergic disease (including drug allergies).
  • Any of the following current (within the past 6 months through the present) DSM-IV Axis I diagnoses: Major depressive disorder, Obsessive compulsive disorder, Panic disorder; Agoraphobia, Posttraumatic stress disorder, Anorexia, Bulimia, Caffeine-induced anxiety disorder, Alcohol or substance abuse or dependence unless in full remission for at least 6 months, Social anxiety disorder.
  • Any of the following past or current DSM IV Axis I diagnoses: Schizophrenia, Psychotic disorder, Delirium, dementia, amnestic, and other clinically significant cognitive disorders, Bipolar or schizoaffective disorder, Cyclothymic disorder, Dissociative disorders.
  • Antisocial or borderline personality disorder.
  • Serious suicidal risk per the clinical investigator's judgment.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: PD 0332334 175 mg BID
Medicin: PD 0332334
Capsules, oral, 300 mg BID, 8 weeks with 2 week taper.
Andre navne:
  • imagabalin
Medicin: PD 0332334
Capsules, oral, 225 mg BID, 8 weeks with 2 week taper.
Medicin: PD 0332334
Capsules, oral, 175 mg BID, 8 weeks with 2 week taper.
Eksperimentel: PD 0332334 225 mg BID
Medicin: PD 0332334
Capsules, oral, 300 mg BID, 8 weeks with 2 week taper.
Andre navne:
  • imagabalin
Medicin: PD 0332334
Capsules, oral, 225 mg BID, 8 weeks with 2 week taper.
Medicin: PD 0332334
Capsules, oral, 175 mg BID, 8 weeks with 2 week taper.
Placebo komparator: Placebo BID
Medicin: Placebo
Capsules, oral, placebo BID, 8 weeks with 2 week taper.
Eksperimentel: PD 0332334 300 mg BID
Medicin: PD 0332334
Capsules, oral, 300 mg BID, 8 weeks with 2 week taper.
Andre navne:
  • imagabalin
Medicin: PD 0332334
Capsules, oral, 225 mg BID, 8 weeks with 2 week taper.
Medicin: PD 0332334
Capsules, oral, 175 mg BID, 8 weeks with 2 week taper.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Effektiviteten af ​​PD 0332334 i behandlingen af ​​GAD vil blive målt ved ændringen i Hamilton Anxiety Rating Scale (HAM-A) samlede score fra baseline observeret efter 8 ugers dobbeltblind behandling.
Tidsramme: 8 uger
8 uger
The safety and tolerability of PD 0332334 in subjects with GAD will be monitored in this study.
Tidsramme: 8 weeks
8 weeks

Sekundære resultatmål

Resultatmål
Tidsramme
Ændring fra baseline i den psykiske subskala-score for HAM-A (punkt 1-6 og 14) i uge 8.
Tidsramme: 8 uger
8 uger
Response rate on the clinician-rated CGI-I at Week 1 and Week 8.
Tidsramme: 8 weeks
8 weeks
Change from Baseline to Week 8 on the Medical Outcomes Study-Sleep Scale (MOSS-SS) subscales.
Tidsramme: 8 weeks
8 weeks
Change from Baseline to Week 8 on the Sheehan Disability Scale (SDS) total score.
Tidsramme: 8 weeks
8 weeks
Change from Baseline to Days 2-8 and Weeks 2, 4, 6, 8 on the DAS-A (total score).
Tidsramme: 8 weeks
8 weeks
Response rate on the HAM-A at Week 1 and Week 8.
Tidsramme: 8 weeks
8 weeks
Change from Baseline in the somatic subscale score of the HAM-A (Items 7-13) at Week 8.
Tidsramme: 8 weeks
8 weeks
Remission rate based on the HAM-A at Week 1 and Week 8.
Tidsramme: 8 weeks
8 weeks
Response rate on the patient-rated PGI-C at Week 8.
Tidsramme: 8 weeks
8 weeks
The "Week 1 Sustained Responder" rate based on the HAM-A (where "Week 1 Sustained Responders" are defined as subjects with a 50% or greater improvement from baseline on the HAM-A total score at Week 1 that is sustained until the Week 8 visit).
Tidsramme: 1 week
1 week
Change from Baseline in HAM-A total score at Weeks 1, 2, 4, and 6.
Tidsramme: 6 weeks
6 weeks
Change from Baseline in the 17-item HAM-D total score at Weeks 1, 2, 4, and 8.
Tidsramme: 8 weeks
8 weeks
Change from Baseline to Week 8 on the Sheehan Disability Scale subscales.
Tidsramme: 8 weeks
8 weeks
Change from Baseline in CGI-S at Week 8.
Tidsramme: 8 weeks
8 weeks
Change from Baseline to Week 8 on the Medical Outcomes Study Sleep Scale (MOS-SS) total score.
Tidsramme: 8 weeks
8 weeks
Change from Baseline to Week 8 in the Q-Les-Q General Activities Score.
Tidsramme: 8 weeks
8 weeks
Change from Baseline to Week 1 on the Medical Outcomes Study Sleep Scale (MOS-SS) total score.
Tidsramme: 1 week
1 week
Change from Baseline to Days 2-8 and Weeks 2, 4, 6, 8 on the GA-VAS (diary).
Tidsramme: 8 weeks
8 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Pfizer

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2007

Primær færdiggørelse (Faktiske)

1. december 2008

Studieafslutning (Faktiske)

1. december 2008

Datoer for studieregistrering

Først indsendt

10. oktober 2007

Først indsendt, der opfyldte QC-kriterier

10. oktober 2007

Først opslået (Skøn)

11. oktober 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

16. november 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. november 2012

Sidst verificeret

1. november 2012

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • A5361017

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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