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

• ClinicalTrials.gov Identifier: NCT00658372
• Recruitment Status: Terminated
• First Posted: April 15, 2008
• Last Update Posted: November 16, 2012
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: April 9, 2008
• First Posted Date: April 15, 2008
• Last Update Posted Date: November 16, 2012
• Study Start Date: May 2008
• Actual Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 9, 2008)

• 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 ]
• The safety and tolerability of PD 0332334 in subjects with GAD will be monitored in this study [ Time Frame: 8 weeks ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 1, 2008)

• Average (across the week 1, 2, 4, 6 and 8 visits) HAM-A change from baseline score [ Time Frame: 8 weeks ]
• Change from baseline in the HAM-A total score at weeks 1, 2, 4, and 6 [ Time Frame: 6 weeks ]
• Change from Baseline to Week 8 on the Medical Outcomes Study Sleep Scale subscales [ Time Frame: 8 weeks ]
• Response rate on the patient-rated PGI-C at week 8 [ Time Frame: 8 weeks ]
• 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 ]
• Change from Baseline to Days 2- 8 and Weeks 2, 4, 6, 8 on the DAS A (total score) [ Time Frame: 8 weeks ]
• Change from Baseline to Week 8 on the Medical Outcomes Study Sleep Scale (MOS SS) Sleep Disturbance Score [ Time Frame: 8 weeks ]
• Response rate on the HAM-A at week 1 and week 8 [ Time Frame: 8 weeks ]
• Change from Baseline to Week 1 on the Medical Outcomes Study Sleep Scale (MOS SS) Sleep Disturbance Score [ Time Frame: 1 week ]
• Change from baseline in the 17-item HAM-D total score at weeks 1, 2, 4, and 8 [ Time Frame: 8 weeks ]
• Change from Baseline in the psychic subscale score of the HAM A (Items 1- 6 and 14) at Week 8 [ Time Frame: 8 weeks ]
• Change from baseline in the somatic subscale score of the HAM-A (items 7 - 13) [ Time Frame: 8 weeks ]
• Change from baseline to week 8 in the QLesQ General Activity Score [ Time Frame: 8 weeks ]
• Worsening and improvement from baseline to week 8 on the changes in the Sexual Functioning Questionnaire (CSFQ) [ Time Frame: 8 weeks ]
• Remission rate based on the HAM A at Week 8 [ Time Frame: 8 weeks ]
• Response rate on the clinician-rated CGI-I ate week 1 and week 8 [ Time Frame: 8 weeks ]
• Change from baseline in CGI-S at week 8 [ Time Frame: 8 weeks ]
• Change from baseline to Days 2-8 and weeks 2, 4, 6 and 8 on the GA-VAS (diary) [ Time Frame: 8 weeks ]
• Change from baseline to week 8 on the Sheehan Disability Scale (SDS) total score [ Time Frame: 8 weeks ]

Original Secondary Outcome Measures (submitted: April 9, 2008)

• Change from Baseline in the psychic subscale score of the HAM A (Items 1- 6 and 14) at Week 8 [ Time Frame: 8 weeks ]
• Change from baseline in the somatic subscale score of the HAM-A (items 7 - 13) [ Time Frame: 8 weeks ]
• Change from baseline to week 8 on the Sheehan Disability Scale subscales [ Time Frame: 8 weeks ]
• Change from Baseline to Week 8 on the Medical Outcomes Study Sleep Scale subscales [ Time Frame: 8 weeks ]
• Change from baseline to week 8 on the Sheehan Disability Scale (SDS) total score [ Time Frame: 8 weeks ]
• Average (across the week 1, 2, 4, 6 and 8 visits) HAM-A change from baseline score [ Time Frame: 8 weeks ]
• Change from baseline in the HAM-A total score at weeks 1, 2, 4, and 6 [ Time Frame: 6 weeks ]
• Remission rate based on the HAM A at Week 8 [ Time Frame: 8 weeks ]
• Response rate on the clinician-rated CGI-I ate week 1 and week 8 [ Time Frame: 8 weeks ]
• Response rate on the patient-rated PGI-C at week 8 [ Time Frame: 8 weeks ]
• Change from baseline to week 8 in the QLesQ General Activity Score [ Time Frame: 8 weeks ]
• Worsening and improvement from baseline to week 8 on the changes in the Sexual Functioning Questionnaire (CSFQ) [ Time Frame: 8 weeks ]
• 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 ]
• Change from Baseline to Days 2- 8 and Weeks 2, 4, 6, 8 on the DAS A (total score) [ Time Frame: 8 weeks ]
• Change from Baseline to Week 8 on the Medical Outcomes Study Sleep Scale (MOS SS) Sleep Problems Index II [ Time Frame: 8 weeks ]
• Response rate on the HAM-A at week 1 and week 8 [ Time Frame: 8 weeks ]
• Change from Baseline to Week 1 on the Medical Outcomes Study Sleep Scale (MOS SS) Sleep Problems Index II [ Time Frame: 1 week ]
• Change from baseline in the 17-item HAM-D total score at weeks 1, 2, 4, and 8 [ Time Frame: 8 weeks ]
• Change from baseline in CGI-S at week 8 [ Time Frame: 8 weeks ]
• Change from basekline to Days 2-8 and weeks 2, 4, 6 and 8 on the GA-VAS (diary) [ Time Frame: 8 weeks ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A 10-week Study Evaluating the Efficacy and Safety of PD 0332334 in Patients With Generalized Anxiety Disorder (2)
• 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
• Brief 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.
• Detailed 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.
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Generalized Anxiety Disorder

Intervention

• Drug: PD 0332334
  Capsules, oral, 225 mg BID, 8 weeks with 2 week taper
  Other Name: imagabalin
• Drug: PD 0332334
  Capsules, oral, 300 mg BID, 8 weeks with 2 week taper
• Drug: Paroxetine
  Capsules, oral, Paroxetine, 20 mg QD, 8 weeks with 2 week taper
• Drug: Placebo
  Capsules, oral, placebo, BID, 8 weeks with 2 week taper

Study Arms

• Experimental: PD 0332334 225 mg BID
  Intervention: Drug: PD 0332334
• Experimental: PD 0332334 300 mg BID
  Intervention: Drug: PD 0332334
• Active Comparator: Paroxetine 20 mg QD
  Intervention: Drug: Paroxetine
• Placebo Comparator: Placebo BID
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: February 12, 2010): 360
• Original Enrollment (submitted: April 9, 2008): 528
• Actual Study Completion Date: March 2009
• Actual Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Hungary, Russian Federation, Taiwan, United States
• Removed Location Countries: Italy

Administrative Information

• NCT Number: NCT00658372
• Other Study ID Numbers: A5361018
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Pfizer
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: November 2012