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Please see Detailed Description for termination reason.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PD 0332334 225 mg BID | Experimental |
| |
| PD 0332334 300 mg BID | Experimental |
| |
| Paroxetine 20 mg q am | Active Comparator |
| |
| Placebo BID | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD 0332334 | Drug | Capsules, oral, 225 mg BID, 8 weeks, with 2 week taper |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in HAM-A total score at Week 8 | 8 weeks | |
| To assess the safety and tolerability of PD 0332334 in subjects with GAD | 8 weeks with taper |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate on the HAM-A at Week 1 and Week 8 | 8 weeks | |
| Remission rate based on the HAM-A at Week 8 | 8 weeks | |
| Change from Baseline in the somatic subscale score of the HAM-A (item 7-13) at Week 8 |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Birmingham | Alabama | 35226 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| PD 0332334 | Drug | Capsules, oral, 300 mg BID, 8 weeks, with 2 week taper |
|
| paroxetine | Drug | Capsules, oral, 20 mg q am, 8 weeks, with 2 week taper |
|
| Placebo | Drug | Capsules, oral, BID, 8 weeks, with 2 week taper |
|
| 8 weeks |
| Change from Baseline to Week 8 on the Medical Outcomes Study - Sleep Scale subscales | 8 weeks |
| Worsening and improvement (from Baseline to Week 8) on the Changes in Sexual Functioning Questionnaire (CSFQ). | 8 weeks |
| Change from Baseline to Week 8 on the Sheehan Disability Scale (SDS) total score | 8 weeks |
| Change from Baseline in the HAM-A total score at Weeks 1, 2, 4 and 6) | 6 weeks |
| Response rate on the PGI-C at Week 8 | 8 weeks |
| Response rate on the CGI-I at Week 1 and Week 8 | 8 weeks |
| Change from Baseline to Week 8 on the Medical Outcomes Study Sleep Scale (MOS-SS) Sleep Disturbance Score | 8 weeks |
| Average (across the Week 1, 2, 4, 6 and 8 visits) HAM-A Change from Baseline score | 8 weeks |
| Change from Baseline to Days 2-8 and Weeks 2, 4, 6 and 8 on the GA-VAS (diary) | 8 weeks |
| The "Week 1 Sustained Responser" rate based on the HAM-A | 8 weeks |
| Change from Baseline in the psychic subscale score of the HAM-A (Items 1-6 and 14) at Week 8. | 8 weeks |
| Change from Baseline to Days 2-8 and Weeks 2, 4, 6, 8 on the DAS-A (total score) | 8 weeks |
| Change from Baseline to Week 8 in the Q-Les-Q General Activities Score | 8 weeks |
| Change from Baseline to Week 1 on the Medical Outcomes Study Sleep Scale (MOS-SS) Sleep Disturbance Score | 1 week |
| Change from Baseline in the 17-item HAM-D total score at Weeks 1, 2, 4, and 8 | 8 weeks |
| Change from Baseline in CGI-S at Week 8 | 8 weeks |
| Glendale |
| California |
| 91206 |
| United States |
| Pfizer Investigational Site | Orange | California | 92868 | United States |
| Pfizer Investigational Site | Temecula | California | 92591 | United States |
| Pfizer Investigational Site | Upland | California | 91786 | United States |
| Pfizer Investigational Site | Wildomar | California | 92595 | United States |
| Pfizer Investigational Site | Fort Myers | Florida | 33912 | United States |
| Pfizer Investigational Site | Orange City | Florida | 32763 | United States |
| Pfizer Investigational Site | Atlanta | Georgia | 30328 | United States |
| Pfizer Investigational Site | Marietta | Georgia | 30060 | United States |
| Pfizer Investigational Site | Greenwood | Indiana | 46143 | United States |
| Pfizer Investigational Site | Wichita | Kansas | 67207 | United States |
| Pfizer Investigational Site | Omaha | Nebraska | 68131 | United States |
| Pfizer Investigational Site | New York | New York | 10021-4256 | United States |
| Pfizer Investigational Site | Syracuse | New York | 13210 | United States |
| Pfizer Investigational Site | Beachwood | Ohio | 44122 | United States |
| Pfizer Investigational Site | Cincinnati | Ohio | 45227 | United States |
| Pfizer Investigational Site | Cleveland | Ohio | 44109-1998 | United States |
| Pfizer Investigational Site | Oklahoma City | Oklahoma | 73103 | United States |
| Pfizer Investigational Site | Oklahoma City | Oklahoma | 73116 | United States |
| Pfizer Investigational Site | Salem | Oregon | 97301 | United States |
| Pfizer Investigational Site | Media | Pennsylvania | 19063 | United States |
| Pfizer Investigational Site | Norristown | Pennsylvania | 19401 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75231 | United States |
| Pfizer Investigational Site | Houston | Texas | 77008 | United States |
| Pfizer Investigational Site | Houston | Texas | 77074 | United States |
| Pfizer Investigational Site | Woodstock | Vermont | 05091 | United States |
| Pfizer Investigational Site | Budapest | 1135 | Hungary |
| ID | Term |
|---|---|
| D000098647 | Generalized Anxiety Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C583768 | imagabalin |
| D017374 | Paroxetine |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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