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

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: NCT00658372
• Other study ID #: A5361018
• Status: Terminated
• Phase: Phase 3
• First received: April 9, 2008
• Last updated: November 9, 2012
• Start date: May 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 18 to 65, with generalized anxiety disorder.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 360
• 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, 225 mg BID, 8 weeks with 2 week taper
• PD 0332334
Capsules, oral, 300 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
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	St. Petersburg
Taiwan	Pfizer Investigational Site	Tainan
United States	Pfizer Investigational Site	Allentown	Pennsylvania
United States	Pfizer Investigational Site	Arcadia	California
United States	Pfizer Investigational Site	Bartlett	Tennessee
United States	Pfizer Investigational Site	Boca Raton	Florida
United States	Pfizer Investigational Site	Costa Mesa	California
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Dayton	Ohio
United States	Pfizer Investigational Site	DeSoto	Texas
United States	Pfizer Investigational Site	Escondido	California
United States	Pfizer Investigational Site	Flint	Michigan
United States	Pfizer Investigational Site	Flint	Michigan
United States	Pfizer Investigational Site	Hamden	Connecticut
United States	Pfizer Investigational Site	Haverhill	Massachusetts
United States	Pfizer Investigational Site	Honolulu	Hawaii
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Los Angeles	California
United States	Pfizer Investigational Site	Memphis	Tennessee
United States	Pfizer Investigational Site	Minneapolis	Minnesota
United States	Pfizer Investigational Site	Naperville	Illinois
United States	Pfizer Investigational Site	New Orleans	Louisiana
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	Olean	New York
United States	Pfizer Investigational Site	Park Ridge	Illinois
United States	Pfizer Investigational Site	Pittsfield	Massachusetts
United States	Pfizer Investigational Site	Prairie Village	Kansas
United States	Pfizer Investigational Site	Rochester	New York
United States	Pfizer Investigational Site	Salt Lake City	Utah
United States	Pfizer Investigational Site	San Diego	California
United States	Pfizer Investigational Site	St. Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Hungary,  Russian Federation,  Taiwan, 

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	Average (across the week 1, 2, 4, 6 and 8 visits) HAM-A change from baseline score		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 to Week 8 on the Medical Outcomes Study Sleep Scale subscales		8 weeks	No
Secondary	Response rate on the patient-rated PGI-C at week 8		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 Medical Outcomes Study Sleep Scale (MOS SS) Sleep Disturbance Score		8 weeks	No
Secondary	Response rate on the HAM-A at week 1 and week 8		8 weeks	No
Secondary	Change from Baseline to Week 1 on the Medical Outcomes Study Sleep Scale (MOS SS) Sleep Disturbance Score		1 week	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 in the psychic subscale score of the HAM A (Items 1- 6 and 14) at Week 8		8 weeks	No
Secondary	Change from baseline in the somatic subscale score of the HAM-A (items 7 - 13)		8 weeks	No
Secondary	Change from baseline to week 8 in the QLesQ General Activity Score		8 weeks	No
Secondary	Worsening and improvement from baseline to week 8 on the changes in the Sexual Functioning Questionnaire (CSFQ)		8 weeks	Yes
Secondary	Remission rate based on the HAM A at 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 CGI-S at week 8		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	Change from baseline to week 8 on the Sheehan Disability Scale (SDS) total score		8 weeks	No

External Links

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