A 10-week Study Evaluating the Efficacy and Safety of PD 0332334 for the Treatment of Generalized Anxiety Disorder (3)

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: NCT00658762
• Other study ID #: A5361020
• Status: Terminated
• Phase: Phase 3
• First received: April 9, 2008
• Last updated: November 9, 2012
• Start date: May 2008
• Est. completion date: April 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 and older 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: 286
• Est. completion date: April 2009
• Est. primary completion date: April 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 diagnoses: 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, 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, 20 mg q am, 8 weeks, with 2 week taper
• Placebo
Capsules, oral, BID, 8 weeks, with 2 week taper

Locations

Country	Name	City	State
Hungary	Pfizer Investigational Site	Budapest
United States	Pfizer Investigational Site	Atlanta	Georgia
United States	Pfizer Investigational Site	Beachwood	Ohio
United States	Pfizer Investigational Site	Birmingham	Alabama
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	Cleveland	Ohio
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Ft. Myers	Florida
United States	Pfizer Investigational Site	Glendale	California
United States	Pfizer Investigational Site	Greenwood	Indiana
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Marietta	Georgia
United States	Pfizer Investigational Site	Media	Pennsylvania
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	Norristown	Pennsylvania
United States	Pfizer Investigational Site	Oklahoma City	Oklahoma
United States	Pfizer Investigational Site	Oklahoma City	Oklahoma
United States	Pfizer Investigational Site	Omaha	Nebraska
United States	Pfizer Investigational Site	Orange	California
United States	Pfizer Investigational Site	Orange City	Florida
United States	Pfizer Investigational Site	Salem	Oregon
United States	Pfizer Investigational Site	Syracuse	New York
United States	Pfizer Investigational Site	Temecula	California
United States	Pfizer Investigational Site	Upland	California
United States	Pfizer Investigational Site	Wichita	Kansas
United States	Pfizer Investigational Site	Wildomar	California
United States	Pfizer Investigational Site	Woodstock	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in HAM-A total score at Week 8		8 weeks	No
Primary	To assess the safety and tolerability of PD 0332334 in subjects with GAD		8 weeks with taper	Yes
Secondary	Response rate on the HAM-A at Week 1 and Week 8		8 weeks	No
Secondary	Remission rate based on the HAM-A at Week 8		8 weeks	No
Secondary	Change from Baseline in the somatic subscale score of the HAM-A (item 7-13) at Week 8		8 weeks	No
Secondary	Change from Baseline to Week 8 on the Medical Outcomes Study - Sleep Scale subscales		8 weeks	No
Secondary	Worsening and improvement (from Baseline to Week 8) on the Changes in Sexual Functioning Questionnaire (CSFQ).		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 in the HAM-A total score at Weeks 1, 2, 4 and 6)		6 weeks	No
Secondary	Response rate on the PGI-C at Week 8		8 weeks	No
Secondary	Response rate on the CGI-I at Week 1 and Week 8		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	Average (across the Week 1, 2, 4, 6 and 8 visits) HAM-A Change from Baseline 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	The "Week 1 Sustained Responser" rate based on the HAM-A		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 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 in the Q-Les-Q General Activities Score		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 CGI-S at Week 8		8 weeks	No

External Links

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