Back to resultsA 10-week Study Evaluating the Efficacy and Safety of PD 0332334 in Patients With Generalized Anxiety Disorder (2)
Primary Purpose
Generalized Anxiety Disorder
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
PD 0332334
PD 0332334
Paroxetine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Generalized Anxiety Disorder focused on measuring PD 0332334 phase 3 pivotal trial
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.
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Active Comparator
Placebo Comparator
Arm Label
PD 0332334 225 mg BID
PD 0332334 300 mg BID
Paroxetine 20 mg QD
Placebo BID
Arm Description
Outcomes
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.
The safety and tolerability of PD 0332334 in subjects with GAD will be monitored in this study
Secondary Outcome Measures
Average (across the week 1, 2, 4, 6 and 8 visits) HAM-A change from baseline score
Change from baseline in the HAM-A total score at weeks 1, 2, 4, and 6
Change from Baseline to Week 8 on the Medical Outcomes Study Sleep Scale subscales
Response rate on the patient-rated PGI-C at week 8
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)
Change from Baseline to Days 2- 8 and Weeks 2, 4, 6, 8 on the DAS A (total score)
Change from Baseline to Week 8 on the Medical Outcomes Study Sleep Scale (MOS SS) Sleep Disturbance Score
Response rate on the HAM-A at week 1 and week 8
Change from Baseline to Week 1 on the Medical Outcomes Study Sleep Scale (MOS SS) Sleep Disturbance Score
Change from baseline in the 17-item HAM-D total score at weeks 1, 2, 4, and 8
Change from Baseline in the psychic subscale score of the HAM A (Items 1- 6 and 14) at Week 8
Change from baseline in the somatic subscale score of the HAM-A (items 7 - 13)
Change from baseline to week 8 in the QLesQ General Activity Score
Worsening and improvement from baseline to week 8 on the changes in the Sexual Functioning Questionnaire (CSFQ)
Remission rate based on the HAM A at Week 8
Response rate on the clinician-rated CGI-I ate week 1 and week 8
Change from baseline in CGI-S at week 8
Change from baseline to Days 2-8 and weeks 2, 4, 6 and 8 on the GA-VAS (diary)
Change from baseline to week 8 on the Sheehan Disability Scale (SDS) total score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00658372
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Terminated
Why Stopped
Please see Detailed Description for termination reason.
Study Start Date
May 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder
Keywords
PD 0332334 phase 3 pivotal trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
360 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PD 0332334 225 mg BID
Arm Type
Experimental
Arm Title
PD 0332334 300 mg BID
Arm Type
Experimental
Arm Title
Paroxetine 20 mg QD
Arm Type
Active Comparator
Arm Title
Placebo BID
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
PD 0332334
Other Intervention Name(s)
imagabalin
Intervention Description
Capsules, oral, 225 mg BID, 8 weeks with 2 week taper
Intervention Type
Drug
Intervention Name(s)
PD 0332334
Intervention Description
Capsules, oral, 300 mg BID, 8 weeks with 2 week taper
Intervention Type
Drug
Intervention Name(s)
Paroxetine
Intervention Description
Capsules, oral, Paroxetine, 20 mg QD, 8 weeks with 2 week taper
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Capsules, oral, placebo, BID, 8 weeks with 2 week taper
Primary Outcome Measure Information:
Title
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
Title
The safety and tolerability of PD 0332334 in subjects with GAD will be monitored in this study
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Average (across the week 1, 2, 4, 6 and 8 visits) HAM-A change from baseline score
Time Frame
8 weeks
Title
Change from baseline in the HAM-A total score at weeks 1, 2, 4, and 6
Time Frame
6 weeks
Title
Change from Baseline to Week 8 on the Medical Outcomes Study Sleep Scale subscales
Time Frame
8 weeks
Title
Response rate on the patient-rated PGI-C at week 8
Time Frame
8 weeks
Title
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
Title
Change from Baseline to Days 2- 8 and Weeks 2, 4, 6, 8 on the DAS A (total score)
Time Frame
8 weeks
Title
Change from Baseline to Week 8 on the Medical Outcomes Study Sleep Scale (MOS SS) Sleep Disturbance Score
Time Frame
8 weeks
Title
Response rate on the HAM-A at week 1 and week 8
Time Frame
8 weeks
Title
Change from Baseline to Week 1 on the Medical Outcomes Study Sleep Scale (MOS SS) Sleep Disturbance Score
Time Frame
1 week
Title
Change from baseline in the 17-item HAM-D total score at weeks 1, 2, 4, and 8
Time Frame
8 weeks
Title
Change from Baseline in the psychic subscale score of the HAM A (Items 1- 6 and 14) at Week 8
Time Frame
8 weeks
Title
Change from baseline in the somatic subscale score of the HAM-A (items 7 - 13)
Time Frame
8 weeks
Title
Change from baseline to week 8 in the QLesQ General Activity Score
Time Frame
8 weeks
Title
Worsening and improvement from baseline to week 8 on the changes in the Sexual Functioning Questionnaire (CSFQ)
Time Frame
8 weeks
Title
Remission rate based on the HAM A at Week 8
Time Frame
8 weeks
Title
Response rate on the clinician-rated CGI-I ate week 1 and week 8
Time Frame
8 weeks
Title
Change from baseline in CGI-S at week 8
Time Frame
8 weeks
Title
Change from baseline to Days 2-8 and weeks 2, 4, 6 and 8 on the GA-VAS (diary)
Time Frame
8 weeks
Title
Change from baseline to week 8 on the Sheehan Disability Scale (SDS) total score
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Arcadia
State/Province
California
ZIP/Postal Code
91007-3462
Country
United States
Facility Name
Pfizer Investigational Site
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92627
Country
United States
Facility Name
Pfizer Investigational Site
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
Facility Name
Pfizer Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Pfizer Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Pfizer Investigational Site
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
Pfizer Investigational Site
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33431
Country
United States
Facility Name
Pfizer Investigational Site
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Pfizer Investigational Site
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60563
Country
United States
Facility Name
Pfizer Investigational Site
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
Pfizer Investigational Site
City
Prairie Village
State/Province
Kansas
ZIP/Postal Code
66206
Country
United States
Facility Name
Pfizer Investigational Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Pfizer Investigational Site
City
Haverhill
State/Province
Massachusetts
ZIP/Postal Code
01830
Country
United States
Facility Name
Pfizer Investigational Site
City
Pittsfield
State/Province
Massachusetts
ZIP/Postal Code
01201
Country
United States
Facility Name
Pfizer Investigational Site
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
Pfizer Investigational Site
City
Flint
State/Province
Michigan
ZIP/Postal Code
48532
Country
United States
Facility Name
Pfizer Investigational Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
Facility Name
Pfizer Investigational Site
City
St. Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Facility Name
Pfizer Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10128-1708
Country
United States
Facility Name
Pfizer Investigational Site
City
Olean
State/Province
New York
ZIP/Postal Code
14760
Country
United States
Facility Name
Pfizer Investigational Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Pfizer Investigational Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45408
Country
United States
Facility Name
Pfizer Investigational Site
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
Facility Name
Pfizer Investigational Site
City
Bartlett
State/Province
Tennessee
ZIP/Postal Code
38134
Country
United States
Facility Name
Pfizer Investigational Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Pfizer Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Pfizer Investigational Site
City
DeSoto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
Facility Name
Pfizer Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
Pfizer Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Pfizer Investigational Site
City
Budapest
ZIP/Postal Code
1212
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
125367
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
St. Petersburg
ZIP/Postal Code
191180
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5361018&StudyName=A%2010-week%20study%20evaluating%20the%20efficacy%20and%20safety%20of%20PD%200332334%20in%20patients%20with%20generalized%20anxiety%20disorder%20%282%29
Description
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A 10-week Study Evaluating the Efficacy and Safety of PD 0332334 in Patients With Generalized Anxiety Disorder (2)
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