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A 5-Week Trial Of PD 0332334 And Alprazolam Extended Release Compared To Placebo In Patients With Generalized Anxiety Disorder

Primary Purpose

Generalized Anxiety Disorder

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
PD 0332334
PD 0332334
placebo
Alprazolam extended release
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Anxiety Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Healthy males or females with a diagnosis of Generalized Anxiety Disorder (GAD) (Diagnostic and Statistical Manual-IV [DSM-IV], 300.02).
  • HAM-A Total Score ≥20 and item #1 on the HAM-D (depressed mood score) ≤2 at both Screening and Baseline/Randomization.

Exclusion Criteria:

  • Current diagnoses (within the 6 months) of Major Depressive Disorder; Obsessive Compulsive Disorder; Panic Disorder; Posttraumatic Stress Disorder; Anorexia; Bulimia; Caffeine-induced anxiety disorder;
  • Any of the following past or current diagnoses: Schizophrenia; Psychotic Disorder; Delirium, Dementia, Bipolar or Schizoaffective Disorder; Cyclothymic Disorder; Dissociative Disorders; Antisocial or borderline personality disorder
  • Current use of psychotropic medications (i.e., drugs normally prescribed for depression, mania, anxiety, insomnia, or psychosis) that could not be discontinued 2 weeks prior to dosing.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Active Comparator

    Arm Label

    PD 0332334 250 mg

    PD 0332334 100 mg

    placebo

    Alprazolam extended release

    Arm Description

    Outcomes

    Primary Outcome Measures

    HAM-A Total Score

    Secondary Outcome Measures

    HAM-A total score at week 1, 2 and 4
    HAM-A somatic and psychic subscales
    HAM-A responders
    HAM-A sustained responders
    DAS-A (daily assessment of symptoms of anxiety) and GA-VAS (VAS scale for global anxiety)
    CGI-I (Clinical Global Impression of Improvement) and PGI-I (Patient Global Impression of Change)
    HAM-D total score
    Sheehan Disability Score (SDS)
    Treatment Satisfaction Questionaire for Medication

    Full Information

    First Posted
    June 15, 2009
    Last Updated
    February 17, 2010
    Sponsor
    Pfizer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00921063
    Brief Title
    A 5-Week Trial Of PD 0332334 And Alprazolam Extended Release Compared To Placebo In Patients With Generalized Anxiety Disorder
    Official Title
    A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, 5-Week Trial To Assess The Efficacy And Safety Of PD 0332334 Compared To Placebo And Alprazolam Extended-Release In Patients With Generalized Anxiety Disorder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2005 (undefined)
    Primary Completion Date
    July 2006 (Actual)
    Study Completion Date
    July 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Pfizer

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the safety and efficacy of PD 0332334 compared to placebo in the treatment of Generalized Anxiety Disorder in an adult population

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Generalized Anxiety Disorder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    222 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PD 0332334 250 mg
    Arm Type
    Experimental
    Arm Title
    PD 0332334 100 mg
    Arm Type
    Experimental
    Arm Title
    placebo
    Arm Type
    Placebo Comparator
    Arm Title
    Alprazolam extended release
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    PD 0332334
    Other Intervention Name(s)
    imagabalin
    Intervention Description
    250 mg capsule, BID for 4 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    PD 0332334
    Intervention Description
    100 mg capsule, BID for 4 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    placebo
    Intervention Description
    0 mg capsule, BID for 4 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Alprazolam extended release
    Other Intervention Name(s)
    Xanax XR
    Intervention Description
    1 mg capsule, BID for 4 weeks
    Primary Outcome Measure Information:
    Title
    HAM-A Total Score
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    HAM-A total score at week 1, 2 and 4
    Time Frame
    1. 2. ands 4 weeks
    Title
    HAM-A somatic and psychic subscales
    Time Frame
    1, 2, and 4 weeks
    Title
    HAM-A responders
    Time Frame
    4 weeks
    Title
    HAM-A sustained responders
    Time Frame
    Week 1 through week 4
    Title
    DAS-A (daily assessment of symptoms of anxiety) and GA-VAS (VAS scale for global anxiety)
    Time Frame
    Day 2 through day 7
    Title
    CGI-I (Clinical Global Impression of Improvement) and PGI-I (Patient Global Impression of Change)
    Time Frame
    1 and 4 weeks
    Title
    HAM-D total score
    Time Frame
    1 and 4 weeks
    Title
    Sheehan Disability Score (SDS)
    Time Frame
    4 weeks
    Title
    Treatment Satisfaction Questionaire for Medication
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Healthy males or females with a diagnosis of Generalized Anxiety Disorder (GAD) (Diagnostic and Statistical Manual-IV [DSM-IV], 300.02). HAM-A Total Score ≥20 and item #1 on the HAM-D (depressed mood score) ≤2 at both Screening and Baseline/Randomization. Exclusion Criteria: Current diagnoses (within the 6 months) of Major Depressive Disorder; Obsessive Compulsive Disorder; Panic Disorder; Posttraumatic Stress Disorder; Anorexia; Bulimia; Caffeine-induced anxiety disorder; Any of the following past or current diagnoses: Schizophrenia; Psychotic Disorder; Delirium, Dementia, Bipolar or Schizoaffective Disorder; Cyclothymic Disorder; Dissociative Disorders; Antisocial or borderline personality disorder Current use of psychotropic medications (i.e., drugs normally prescribed for depression, mania, anxiety, insomnia, or psychosis) that could not be discontinued 2 weeks prior to dosing.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pfizer CT.gov Call Center
    Organizational Affiliation
    Pfizer
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5361007&StudyName=A%205-Week%20Trial%20Of%20PD%200332334%20And%20Alprazolam%20Extended%20Release%20Compared%20To%20Placebo%20In%20Patients%20With%20Generalized%20Anxiety%20Disorder
    Description
    To obtain contact information for a study center near you, click here.

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    A 5-Week Trial Of PD 0332334 And Alprazolam Extended Release Compared To Placebo In Patients With Generalized Anxiety Disorder

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