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

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00658008

Purpose

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.

Condition	Intervention	Phase
Generalized Anxiety Disorder	Drug: PD 0332334 Drug: Paroxetine Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Anxiety

Drug Information available for: Paroxetine Paroxetine hydrochloride Paroxetine Mesylate

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
The safety and tolerability of PD 0332334 in subjects with GAD will be monitored in this study [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Worsening and improvement from baseline to week 8 on the changes in the Sexual Functioning Questionnaire (CSFQ) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Response rate on the patient-rated PGI-C at week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Change from baseline to week 8 on the Sheehan Disability Scale subscales [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Change from baseline in the somatic subscale score of the HAM-A (items 7 - 13) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Response rate on the HAM-A at week 1 and week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Response rate on the clinician-rated CGI-I ate week 1 and week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Change from Baseline in the psychic subscale score of the HAM A (Items 1- 6 and 14) at Week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Change from Baseline to Week 1 on the Medical Outcomes Study Sleep Scale (MOS SS) Sleep Problems Index II [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Change from Baseline to Week 8 on the Medical Outcomes Study Sleep Scale (MOS SS) Sleep Problems Index II [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Change from baseline in the HAM-A total score at weeks 1, 2, 4, and 6 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Change from baseline in the 17-item HAM-D total score at weeks 1, 2, 4, and 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Change from Baseline to Week 8 on the Medical Outcomes Study Sleep Scale subscales [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Remission rate based on the HAM A at Week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Change from baseline in CGI-S at week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Change from baseline to week 8 in the QLesQ General Activity Score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Change from Baseline to Days 2 8 and Weeks 2, 4, 6, 8 on the DAS A (total score) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Change from baseline to week 8 on the Sheehan Disability Scale (SDS) total score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Change from baseline to Days 2-8 and weeks 2, 4, 6 and 8 on the GA-VAS (diary) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Average (across the week 1, 2, 4, 6 and 8 visits) HAM-A change from baseline score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment:	501
Study Start Date:	April 2008
Study Completion Date:	March 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
PD 0332334 175 mg BID: Experimental	Drug: PD 0332334 Capsules, oral, 175 mg BID, 8 weeks with 2 week taper
PD 0332334 225 mg BID: Experimental	Drug: PD 0332334 Capsules, oral, 225 mg BID, 8 weeks with 2 week taper
PD 0332334 75 mg BID: Experimental	Drug: PD 0332334 Capsules, oral, 75 mg BID, 8 weeks with 2 week taper
Paroxetine 20 mg QD: Active Comparator	Drug: Paroxetine Capsules, oral, Paroxetine 20 mg QD, 8 weeks with 2 week taper
Placebo BID: Placebo Comparator	Drug: Placebo Capsules, oral, placebo bid, 8 weeks with 2 week taper

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

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00658008

Hide Study Locations

Locations

United States, Arizona
Pfizer Investigational Site
Litchfield Park, Arizona, United States, 85340
United States, California
Pfizer Investigational Site
Pasadena, California, United States, 91106
Pfizer Investigational Site
Redlands, California, United States, 92374
Pfizer Investigational Site
Costa Mesa, California, United States, 92626
United States, Colorado
Pfizer Investigational Site
Denver, Colorado, United States, 80239
United States, Connecticut
Pfizer Investigational Site
Norwich, Connecticut, United States, 06360
United States, Florida
Pfizer Investigational Site
Maitland, Florida, United States, 32751
Pfizer Investigational Site
Miami, Florida, United States, 33143
Pfizer Investigational Site
Miami, Florida, United States, 33126
Pfizer Investigational Site
Altamonte Springs, Florida, United States, 32701
Pfizer Investigational Site
South Miami, Florida, United States, 33143
United States, Indiana
Pfizer Investigational Site
Terre Haute, Indiana, United States, 47802
United States, Kansas
Pfizer Investigational Site
Overland Park, Kansas, United States, 66212
Pfizer Investigational Site
Topeka, Kansas, United States, 66606
United States, Louisiana
Pfizer Investigational Site
Shreveport, Louisiana, United States, 71104
United States, Maryland
Pfizer Investigational Site
Baltimore, Maryland, United States, 21208
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02135
United States, Missouri
Pfizer Investigational Site
St. Charles, Missouri, United States, 63301
United States, Nevada
Pfizer Investigational Site
Las Vegas, Nevada, United States, 89146
United States, New Jersey
Pfizer Investigational Site
Clementon, New Jersey, United States, 08021
Pfizer Investigational Site
Willingboro, New Jersey, United States, 08046
United States, New Mexico
Pfizer Investigational Site
Albuquerque, New Mexico, United States, 87109
United States, New York
Pfizer Investigational Site
Bronx, New York, United States, 10467
Pfizer Investigational Site
New York, New York, United States, 10023
Pfizer Investigational Site
Bronx, New York, United States, 10454
Pfizer Investigational Site
Brooklyn, New York, United States, 11235
United States, North Carolina
Pfizer Investigational Site
Raleigh, North Carolina, United States, 27607
United States, Ohio
Pfizer Investigational Site
Toledo, Ohio, United States, 43609
Pfizer Investigational Site
Toledo, Ohio, United States, 43623
United States, Oklahoma
Pfizer Investigational Site
Bethany, Oklahoma, United States, 73008
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19104
Pfizer Investigational Site
Media, Pennsylvania, United States, 19063
Pfizer Investigational Site
Bala Cynwyd, Pennsylvania, United States, 19004
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19136
Pfizer Investigational Site
Norristown, Pennsylvania, United States, 19401
United States, South Carolina
Pfizer Investigational Site
Columbia, South Carolina, United States, 29201
United States, Tennessee
Pfizer Investigational Site
Memphis, Tennessee, United States, 38117
United States, Texas
Pfizer Investigational Site
Lake Jackson, Texas, United States, 77566
Pfizer Investigational Site
San Antonio, Texas, United States, 78229
Pfizer Investigational Site
Austin, Texas, United States, 78756
Pfizer Investigational Site
Dallas, Texas, United States, 75231
United States, Vermont
Pfizer Investigational Site
Burlington, Vermont, United States, 05401
United States, Virginia
Pfizer Investigational Site
Charlottesville, Virginia, United States, 22903
Pfizer Investigational Site
Charlottesville, Virginia, United States, 22911
United States, Wisconsin
Pfizer Investigational Site
Waukesha, Wisconsin, United States, 53188-1660
Hungary
Pfizer Investigational Site
Budapest, Hungary, 1137
Pfizer Investigational Site
Budapest, Hungary, 1095
Italy
Pfizer Investigational Site
Catania, Italy, 95123
Pfizer Investigational Site
Torino, Italy, 10126
Korea, Republic of
Pfizer Investigational Site
Seoul, Korea, Republic of, 138-736
Pfizer Investigational Site
Seoul, Korea, Republic of, 135-710
Russian Federation
Pfizer Investigational Site
Khotkovo, Moscow region, Russian Federation, 142601

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A5361019
Study First Received:	April 8, 2008
Last Updated:	June 18, 2009
ClinicalTrials.gov Identifier:	NCT00658008 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

PD 0332334 phase 3 pivotal trial

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Paroxetine
Serotonin Uptake Inhibitors
Pharmacologic Actions

Pathologic Processes
Serotonin Agents
Anxiety Disorders
Mental Disorders
Therapeutic Uses
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on November 25, 2009