A Phase 3 interventional study of PD 0332334 and PD 0332334 in Generalized Anxiety Disorder, sponsored by Pfizer. Terminated at 52 sites in 5 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2012-11-16.
Sponsored by Pfizer · Phase 3, Interventional, and Treatment
This is a 10-week trial that evaluates the efficacy and safety of PD 0332334 in subjects, ages from 18 to 65, 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.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's enrollment of 501 is above the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: PD 0332334
Drug: PD 0332334
Drug: PD 0332334
Drug: Paroxetine
Drug: Placebo
Capsules, oral, 175 mg BID, 8 weeks with 2 week taper
Also known as: imagabalin
Capsules, oral, 225 mg BID, 8 weeks with 2 week taper
Capsules, oral, 75 mg BID, 8 weeks with 2 week taper
Capsules, oral, Paroxetine 20 mg QD, 8 weeks with 2 week taper
Capsules, oral, placebo bid, 8 weeks with 2 week taper
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
Worsening and improvement from baseline to week 8 on the changes in the Sexual Functioning Questionnaire (CSFQ)
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 on the Sheehan Disability Scale subscales
Time frame: 8 weeks
Change from baseline in the somatic subscale score of the HAM-A (items 7 - 13)
Time frame: 8 weeks
Response rate on the HAM-A at week 1 and 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 the psychic subscale score of the HAM A (Items 1- 6 and 14) at 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 to Week 8 on the Medical Outcomes Study Sleep Scale (MOS SS) Sleep Problems Index II
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 in the 17-item HAM-D total score at weeks 1, 2, 4, and 8
Time frame: 8 weeks
Change from Baseline to Week 8 on the Medical Outcomes Study Sleep Scale subscales
Time frame: 8 weeks
Remission rate based on the HAM A at Week 8
Time frame: 8 weeks
Change from baseline in CGI-S at week 8
Time frame: 8 weeks
Change from baseline to week 8 in the QLesQ General Activity Score
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 Sheehan Disability Scale (SDS) total score
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
Average (across the week 1, 2, 4, 6 and 8 visits) HAM-A change from baseline score
Time frame: 8 weeks
This study is terminated, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.
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