A Phase 3 interventional study of PD 0332334 and Placebo in Generalized Anxiety Disorder, sponsored by Pfizer. Completed at 43 sites in United States. 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 study will evaluate the efficacy and safety of PD 0332334 for the treatment of generalized anxiety disorder.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's enrollment of 551 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: Placebo
Drug: PD 0332334
Drug: PD 0332334
Capsules, oral, 300 mg BID, 8 weeks with 2 week taper.
Also known as: imagabalin
Capsules, oral, placebo BID, 8 weeks with 2 week taper.
Capsules, oral, 225 mg BID, 8 weeks with 2 week taper.
Capsules, oral, 175 mg 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
Response rate on the clinician-rated CGI-I at Week 1 and Week 8.
Time frame: 8 weeks
Change from Baseline to Week 8 on the Medical Outcomes Study-Sleep Scale (MOSS-SS) subscales.
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, 8 on the DAS-A (total score).
Time frame: 8 weeks
Response rate on the HAM-A at Week 1 and Week 8.
Time frame: 8 weeks
Change from Baseline in the somatic subscale score of the HAM-A (Items 7-13) at Week 8.
Time frame: 8 weeks
Remission rate based on the HAM-A at Week 1 and Week 8.
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 in 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 Sheehan Disability Scale subscales.
Time frame: 8 weeks
Change from Baseline in CGI-S at 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 8 on the Medical Outcomes Study Sleep Scale (MOS-SS) total score.
Time frame: 8 weeks
Change from Baseline to Week 8 in the Q-Les-Q General Activities Score.
Time frame: 8 weeks
Change from Baseline to Week 1 on the Medical Outcomes Study Sleep Scale (MOS-SS) total score.
Time frame: 1 week
Change from Baseline to Days 2-8 and Weeks 2, 4, 6, 8 on the GA-VAS (diary).
Time frame: 8 weeks
This study is completed, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.
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