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

Generalized Anxiety Disorder Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00658008
• Other study ID #: A5361019
• Status: Terminated
• Phase: Phase 3
• First received: April 8, 2008
• Last updated: November 9, 2012
• Start date: April 2008
• Est. completion date: March 2009

Study information

• Verified date: November 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 501
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Generalized Anxiety Disorder

Intervention

Drug:
• PD 0332334
Capsules, oral, 175 mg BID, 8 weeks with 2 week taper
• PD 0332334
Capsules, oral, 225 mg BID, 8 weeks with 2 week taper
• PD 0332334
Capsules, oral, 75 mg BID, 8 weeks with 2 week taper
• Paroxetine
Capsules, oral, Paroxetine 20 mg QD, 8 weeks with 2 week taper
• Placebo
Capsules, oral, placebo bid, 8 weeks with 2 week taper

Locations

Country	Name	City	State
Hungary	Pfizer Investigational Site	Budapest
Hungary	Pfizer Investigational Site	Budapest
Italy	Pfizer Investigational Site	Catania
Italy	Pfizer Investigational Site	Torino
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Russian Federation	Pfizer Investigational Site	Khotkovo, Moscow region
United States	Pfizer Investigational Site	Albuquerque	New Mexico
United States	Pfizer Investigational Site	Altamonte Springs	Florida
United States	Pfizer Investigational Site	Austin	Texas
United States	Pfizer Investigational Site	Bala Cynwyd	Pennsylvania
United States	Pfizer Investigational Site	Baltimore	Maryland
United States	Pfizer Investigational Site	Bethany	Oklahoma
United States	Pfizer Investigational Site	Boston	Massachusetts
United States	Pfizer Investigational Site	Bronx	New York
United States	Pfizer Investigational Site	Bronx	New York
United States	Pfizer Investigational Site	Brooklyn	New York
United States	Pfizer Investigational Site	Burlington	Vermont
United States	Pfizer Investigational Site	Charlottesville	Virginia
United States	Pfizer Investigational Site	Charlottesville	Virginia
United States	Pfizer Investigational Site	Clementon	New Jersey
United States	Pfizer Investigational Site	Columbia	South Carolina
United States	Pfizer Investigational Site	Costa Mesa	California
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Denver	Colorado
United States	Pfizer Investigational Site	Lake Jackson	Texas
United States	Pfizer Investigational Site	Las Vegas	Nevada
United States	Pfizer Investigational Site	Litchfield Park	Arizona
United States	Pfizer Investigational Site	Maitland	Florida
United States	Pfizer Investigational Site	Media	Pennsylvania
United States	Pfizer Investigational Site	Memphis	Tennessee
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	Norristown	Pennsylvania
United States	Pfizer Investigational Site	Norwich	Connecticut
United States	Pfizer Investigational Site	Overland Park	Kansas
United States	Pfizer Investigational Site	Pasadena	California
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania
United States	Pfizer Investigational Site	Raleigh	North Carolina
United States	Pfizer Investigational Site	Redlands	California
United States	Pfizer Investigational Site	San Antonio	Texas
United States	Pfizer Investigational Site	Shreveport	Louisiana
United States	Pfizer Investigational Site	South Miami	Florida
United States	Pfizer Investigational Site	St. Charles	Missouri
United States	Pfizer Investigational Site	Terre Haute	Indiana
United States	Pfizer Investigational Site	Toledo	Ohio
United States	Pfizer Investigational Site	Toledo	Ohio
United States	Pfizer Investigational Site	Topeka	Kansas
United States	Pfizer Investigational Site	Waukesha	Wisconsin
United States	Pfizer Investigational Site	Willingboro	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Hungary,  Italy,  Korea, Republic of,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		8 weeks	No
Primary	The safety and tolerability of PD 0332334 in subjects with GAD will be monitored in this study		8 weeks	Yes
Secondary	Worsening and improvement from baseline to week 8 on the changes in the Sexual Functioning Questionnaire (CSFQ)		8 weeks	No
Secondary	Response rate on the patient-rated PGI-C at week 8		8 weeks	No
Secondary	Change from baseline to week 8 on the Sheehan Disability Scale subscales		8 weeks	No
Secondary	Change from baseline in the somatic subscale score of the HAM-A (items 7 - 13)		8 weeks	No
Secondary	Response rate on the HAM-A at week 1 and week 8		8 weeks	No
Secondary	Response rate on the clinician-rated CGI-I ate week 1 and week 8		8 weeks	No
Secondary	Change from Baseline in the psychic subscale score of the HAM A (Items 1- 6 and 14) at Week 8		8 weeks	No
Secondary	Change from Baseline to Week 1 on the Medical Outcomes Study Sleep Scale (MOS SS) Sleep Problems Index II		1 week	No
Secondary	Change from Baseline to Week 8 on the Medical Outcomes Study Sleep Scale (MOS SS) Sleep Problems Index II		8 weeks	No
Secondary	Change from baseline in the HAM-A total score at weeks 1, 2, 4, and 6		6 weeks	No
Secondary	Change from baseline in the 17-item HAM-D total score at weeks 1, 2, 4, and 8		8 weeks	No
Secondary	Change from Baseline to Week 8 on the Medical Outcomes Study Sleep Scale subscales		8 weeks	No
Secondary	Remission rate based on the HAM A at Week 8		8 weeks	No
Secondary	Change from baseline in CGI-S at week 8		8 weeks	No
Secondary	Change from baseline to week 8 in the QLesQ General Activity Score		8 weeks	No
Secondary	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)		1 week	No
Secondary	Change from Baseline to Days 2 8 and Weeks 2, 4, 6, 8 on the DAS A (total score)		8 weeks	No
Secondary	Change from baseline to week 8 on the Sheehan Disability Scale (SDS) total score		8 weeks	No
Secondary	Change from baseline to Days 2-8 and weeks 2, 4, 6 and 8 on the GA-VAS (diary)		8 weeks	No
Secondary	Average (across the week 1, 2, 4, 6 and 8 visits) HAM-A change from baseline score		8 weeks	No

External Links

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