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A 10-week Study Evaluating the Efficacy and Safety of PD 0332334 in Patients With Generalized Anxiety Disorder (1)

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Generalized Anxiety Disorder

Intervention: PD 0332334 (Drug); PD 0332334 (Drug); PD 0332334 (Drug); Paroxetine (Drug); Placebo (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

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

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

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.

The safety and tolerability of PD 0332334 in subjects with GAD will be monitored in this study

Secondary outcome:

Worsening and improvement from baseline to week 8 on the changes in the Sexual Functioning Questionnaire (CSFQ)

Response rate on the patient-rated PGI-C at week 8

Change from baseline to week 8 on the Sheehan Disability Scale subscales

Change from baseline in the somatic subscale score of the HAM-A (items 7 - 13)

Response rate on the HAM-A at week 1 and week 8

Response rate on the clinician-rated CGI-I ate week 1 and week 8

Change from Baseline in the psychic subscale score of the HAM A (Items 1- 6 and 14) at Week 8

Change from Baseline to Week 1 on the Medical Outcomes Study Sleep Scale (MOS SS) Sleep Problems Index II

Change from Baseline to Week 8 on the Medical Outcomes Study Sleep Scale (MOS SS) Sleep Problems Index II

Change from baseline in the HAM-A total score at weeks 1, 2, 4, and 6

Change from baseline in the 17-item HAM-D total score at weeks 1, 2, 4, and 8

Change from Baseline to Week 8 on the Medical Outcomes Study Sleep Scale subscales

Remission rate based on the HAM A at Week 8

Change from baseline in CGI-S at week 8

Change from baseline to week 8 in the QLesQ General Activity Score

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)

Change from Baseline to Days 2 8 and Weeks 2, 4, 6, 8 on the DAS A (total score)

Change from baseline to week 8 on the Sheehan Disability Scale (SDS) total score

Change from baseline to Days 2-8 and weeks 2, 4, 6 and 8 on the GA-VAS (diary)

Average (across the week 1, 2, 4, 6 and 8 visits) HAM-A change from baseline score

Detailed description: Termination reason: 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.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Pfizer Investigational Site, Budapest 1095, Hungary

Pfizer Investigational Site, Budapest 1137, Hungary

Pfizer Investigational Site, Catania 95123, Italy

Pfizer Investigational Site, Torino 10126, Italy

Pfizer Investigational Site, Seoul 135-710, Korea, Republic of

Pfizer Investigational Site, Seoul 138-736, Korea, Republic of

Pfizer Investigational Site, Khotkovo, Moscow region 142601, Russian Federation

Pfizer Investigational Site, Litchfield Park, Arizona 85340, United States

Pfizer Investigational Site, Costa Mesa, California 92626, United States

Pfizer Investigational Site, Pasadena, California 91106, United States

Pfizer Investigational Site, Redlands, California 92374, United States

Pfizer Investigational Site, Denver, Colorado 80239, United States

Pfizer Investigational Site, Norwich, Connecticut 06360, United States

Pfizer Investigational Site, Altamonte Springs, Florida 32701, United States

Pfizer Investigational Site, Maitland, Florida 32751, United States

Pfizer Investigational Site, Miami, Florida 33126, United States

Pfizer Investigational Site, Miami, Florida 33143, United States

Pfizer Investigational Site, South Miami, Florida 33143, United States

Pfizer Investigational Site, Terre Haute, Indiana 47802, United States

Pfizer Investigational Site, Overland Park, Kansas 66212, United States

Pfizer Investigational Site, Topeka, Kansas 66606, United States

Pfizer Investigational Site, Shreveport, Louisiana 71104, United States

Pfizer Investigational Site, Baltimore, Maryland 21208, United States

Pfizer Investigational Site, Boston, Massachusetts 02135, United States

Pfizer Investigational Site, St. Charles, Missouri 63301, United States

Pfizer Investigational Site, Las Vegas, Nevada 89146, United States

Pfizer Investigational Site, Clementon, New Jersey 08021, United States

Pfizer Investigational Site, Willingboro, New Jersey 08046, United States

Pfizer Investigational Site, Albuquerque, New Mexico 87109, United States

Pfizer Investigational Site, Bronx, New York 10454, United States

Pfizer Investigational Site, Bronx, New York 10467, United States

Pfizer Investigational Site, Brooklyn, New York 11235, United States

Pfizer Investigational Site, New York, New York 10023, United States

Pfizer Investigational Site, Raleigh, North Carolina 27607, United States

Pfizer Investigational Site, Toledo, Ohio 43609, United States

Pfizer Investigational Site, Toledo, Ohio 43623, United States

Pfizer Investigational Site, Bethany, Oklahoma 73008, United States

Pfizer Investigational Site, Bala Cynwyd, Pennsylvania 19004, United States

Pfizer Investigational Site, Media, Pennsylvania 19063, United States

Pfizer Investigational Site, Norristown, Pennsylvania 19401, United States

Pfizer Investigational Site, Philadelphia, Pennsylvania 19136, United States

Pfizer Investigational Site, Philadelphia, Pennsylvania 19104, United States

Pfizer Investigational Site, Columbia, South Carolina 29201, United States

Pfizer Investigational Site, Memphis, Tennessee 38117, United States

Pfizer Investigational Site, Austin, Texas 78756, United States

Pfizer Investigational Site, Dallas, Texas 75231, United States

Pfizer Investigational Site, Lake Jackson, Texas 77566, United States

Pfizer Investigational Site, San Antonio, Texas 78229, United States

Pfizer Investigational Site, Burlington, Vermont 05401, United States

Pfizer Investigational Site, Charlottesville, Virginia 22911, United States

Pfizer Investigational Site, Charlottesville, Virginia 22903, United States

Pfizer Investigational Site, Waukesha, Wisconsin 53188-1660, United States

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: April 2008
Last updated: November 9, 2012

Page last updated: August 23, 2015

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