A 10-week Study Evaluating the Efficacy and Safety of PD 0332334 in Patients With Generalized Anxiety Disorder (2)

November 9, 2012 updated by: Pfizer

A Phase 3, Randomized, Double-Blind, Parallel Group, 10-Week Placebo Controlled Fixed Dose Study Of PD 0332334 And Paroxetine Evaluating The Efficacy And Safety Of PD 0332334 For The Treatment Of Generalized Anxiety Disorder

This is a 10-week trial that evaluates the efficacy and safety of PD 0332334 in subjects, ages 18 to 65, with generalized anxiety disorder.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

On February 23rd 2009, a decision to terminate further development for PD 0332334 was communicated to investigators in this study. The decision to terminate this study was not based on any safety concerns.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
360

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Budapest, Hungary, 1212
        • Pfizer Investigational Site
  • Russian Federation
      • Moscow, Russian Federation, 125367
        • Pfizer Investigational Site
      • St. Petersburg, Russian Federation, 191180
        • Pfizer Investigational Site
  • Taiwan
      • Tainan, Taiwan, 704
        • Pfizer Investigational Site
  • United States
    • California
      • Arcadia, California, United States, 91007-3462
        • Pfizer Investigational Site
      • Costa Mesa, California, United States, 92627
        • Pfizer Investigational Site
      • Escondido, California, United States, 92025
        • Pfizer Investigational Site
      • Los Angeles, California, United States, 90048
        • Pfizer Investigational Site
      • San Diego, California, United States, 92108
        • Pfizer Investigational Site
    • Connecticut
      • Hamden, Connecticut, United States, 06518
        • Pfizer Investigational Site
    • Florida
      • Boca Raton, Florida, United States, 33431
        • Pfizer Investigational Site
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Pfizer Investigational Site
    • Illinois
      • Naperville, Illinois, United States, 60563
        • Pfizer Investigational Site
      • Park Ridge, Illinois, United States, 60068
        • Pfizer Investigational Site
    • Kansas
      • Prairie Village, Kansas, United States, 66206
        • Pfizer Investigational Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • Pfizer Investigational Site
    • Massachusetts
      • Haverhill, Massachusetts, United States, 01830
        • Pfizer Investigational Site
      • Pittsfield, Massachusetts, United States, 01201
        • Pfizer Investigational Site
    • Michigan
      • Flint, Michigan, United States, 48532
        • Pfizer Investigational Site
      • Flint, Michigan, United States, 48503
        • Pfizer Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55454
        • Pfizer Investigational Site
      • St. Paul, Minnesota, United States, 55101
        • Pfizer Investigational Site
    • New York
      • New York, New York, United States, 10128-1708
        • Pfizer Investigational Site
      • Olean, New York, United States, 14760
        • Pfizer Investigational Site
      • Rochester, New York, United States, 14618
        • Pfizer Investigational Site
    • Ohio
      • Dayton, Ohio, United States, 45408
        • Pfizer Investigational Site
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18104
        • Pfizer Investigational Site
    • Tennessee
      • Bartlett, Tennessee, United States, 38134
        • Pfizer Investigational Site
      • Memphis, Tennessee, United States, 38119
        • Pfizer Investigational Site
    • Texas
      • Dallas, Texas, United States, 75230
        • Pfizer Investigational Site
      • DeSoto, Texas, United States, 75115
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77090
        • Pfizer Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 diagnosis: 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PD 0332334 225 mg BID
Drug: PD 0332334
Capsules, oral, 225 mg BID, 8 weeks with 2 week taper
Other Names:
  • imagabalin
Drug: PD 0332334
Capsules, oral, 300 mg BID, 8 weeks with 2 week taper
Active Comparator: Paroxetine 20 mg QD
Drug: Paroxetine
Capsules, oral, Paroxetine, 20 mg QD, 8 weeks with 2 week taper
Placebo Comparator: Placebo BID
Drug: Placebo
Capsules, oral, placebo, BID, 8 weeks with 2 week taper
Experimental: PD 0332334 300 mg BID
Drug: PD 0332334
Capsules, oral, 225 mg BID, 8 weeks with 2 week taper
Other Names:
  • imagabalin
Drug: PD 0332334
Capsules, oral, 300 mg BID, 8 weeks with 2 week taper

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The efficacy of PD 0332334 in the treatment of GAD will be measured by the change in the Hamilton Anxiety Rating Scale (HAM-A) total scores from baseline observed following 8 weeks of double-blind treatment.
Time Frame: 8 weeks
8 weeks
The safety and tolerability of PD 0332334 in subjects with GAD will be monitored in this study
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Worsening and improvement from baseline to week 8 on the changes in the Sexual Functioning Questionnaire (CSFQ)
Time Frame: 8 weeks
8 weeks
Response rate on the patient-rated PGI-C at week 8
Time Frame: 8 weeks
8 weeks
Change from baseline in the somatic subscale score of the HAM-A (items 7 - 13)
Time Frame: 8 weeks
8 weeks
Response rate on the HAM-A at week 1 and week 8
Time Frame: 8 weeks
8 weeks
Response rate on the clinician-rated CGI-I ate week 1 and week 8
Time Frame: 8 weeks
8 weeks
Change from Baseline in the psychic subscale score of the HAM A (Items 1- 6 and 14) at Week 8
Time Frame: 8 weeks
8 weeks
Change from baseline in the HAM-A total score at weeks 1, 2, 4, and 6
Time Frame: 6 weeks
6 weeks
Change from baseline in the 17-item HAM-D total score at weeks 1, 2, 4, and 8
Time Frame: 8 weeks
8 weeks
Change from Baseline to Week 8 on the Medical Outcomes Study Sleep Scale subscales
Time Frame: 8 weeks
8 weeks
Remission rate based on the HAM A at Week 8
Time Frame: 8 weeks
8 weeks
Change from baseline in CGI-S at week 8
Time Frame: 8 weeks
8 weeks
Change from baseline to week 8 in the QLesQ General Activity Score
Time Frame: 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)
Time Frame: 1 week
1 week
Change from baseline to week 8 on the Sheehan Disability Scale (SDS) total score
Time Frame: 8 weeks
8 weeks
Change from baseline to Days 2-8 and weeks 2, 4, 6 and 8 on the GA-VAS (diary)
Time Frame: 8 weeks
8 weeks
Average (across the week 1, 2, 4, 6 and 8 visits) HAM-A change from baseline score
Time Frame: 8 weeks
8 weeks
Change from Baseline to Days 2- 8 and Weeks 2, 4, 6, 8 on the DAS A (total score)
Time Frame: 8 weeks
8 weeks
Change from Baseline to Week 8 on the Medical Outcomes Study Sleep Scale (MOS SS) Sleep Disturbance Score
Time Frame: 8 weeks
8 weeks
Change from Baseline to Week 1 on the Medical Outcomes Study Sleep Scale (MOS SS) Sleep Disturbance Score
Time Frame: 1 week
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 9, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 15, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 16, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A5361018

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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