Expired Study
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Birmingham, Alabama 35226


Purpose:

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.


Study summary:

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.


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 diagnoses: 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.


Study is Available At:


Original ID:

A5361020


NCT ID:

NCT00658762


Secondary ID:


Study Acronym:


Brief Title:

A 10-week Study Evaluating the Efficacy and Safety of PD 0332334 for the Treatment of Generalized Anxiety Disorder (3)


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


Overall Status:

Terminated


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Pfizer


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:

Please see Detailed Description for terminat


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

4


Number of Groups:

0


Total Enrollment:

286


Enrollment Type:

Actual


Overall Contact Information

Official Name:Pfizer CT.gov Call Center
Study Director
Pfizer

Study Dates

Start Date:May 2008
Completion Date:April 2009
Completion Type:Actual
Primary Completion Date:April 2009
Primary Completion Type:Actual
Verification Date:September 2010
Last Changed Date:September 14, 2010
First Received Date:April 9, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Change from Baseline in CGI-S at Week 8
Time Frame:8 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change from Baseline in the 17-item HAM-D total score at Weeks 1, 2, 4, and 8
Time Frame:8 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change from Baseline to Week 1 on the Medical Outcomes Study Sleep Scale (MOS-SS) Sleep Disturbance Score
Time Frame:1 week
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change from Baseline to Week 8 in the Q-Les-Q General Activities Score
Time Frame:8 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change from Baseline to Days 2-8 and Weeks 2, 4, 6, 8 on the DAS-A (total score)
Time Frame:8 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change from Baseline in the psychic subscale score of the HAM-A (Items 1-6 and 14) at Week 8.
Time Frame:8 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:The "Week 1 Sustained Responser" rate based on the HAM-A
Time Frame:8 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change from Baseline to Days 2-8 and Weeks 2, 4, 6 and 8 on the GA-VAS (diary)
Time Frame:8 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Average (across the Week 1, 2, 4, 6 and 8 visits) HAM-A Change from Baseline score
Time Frame:8 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change from Baseline to Week 8 on the Medical Outcomes Study Sleep Scale (MOS-SS) Sleep Disturbance Score
Time Frame:8 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Response rate on the CGI-I at Week 1 and Week 8
Time Frame:8 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Response rate on the PGI-C at Week 8
Time Frame:8 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change from Baseline in the HAM-A total score at Weeks 1, 2, 4 and 6)
Time Frame:6 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change from Baseline to Week 8 on the Sheehan Disability Scale (SDS) total score
Time Frame:8 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Worsening and improvement (from Baseline to Week 8) on the Changes in Sexual Functioning Questionnaire (CSFQ).
Time Frame:8 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change from Baseline to Week 8 on the Medical Outcomes Study - Sleep Scale subscales
Time Frame:8 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change from Baseline in the somatic subscale score of the HAM-A (item 7-13) at Week 8
Time Frame:8 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Remission rate based on the HAM-A at Week 8
Time Frame:8 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Response rate on the HAM-A at Week 1 and Week 8
Time Frame:8 weeks
Safety Issues:False
Outcome Type:Primary Outcome
Measure:To assess the safety and tolerability of PD 0332334 in subjects with GAD
Time Frame:8 weeks with taper
Safety Issues:True
Outcome Type:Primary Outcome
Measure:Change from Baseline in HAM-A total score at Week 8
Time Frame:8 weeks
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:PD 0332334
Description:Capsules, oral, 225 mg BID, 8 weeks, with 2 week taper
Arm Name:PD 0332334 225 mg BID
Other Name:imagabalin
Intervention Type:Drug
Name:PD 0332334
Description:Capsules, oral, 300 mg BID, 8 weeks, with 2 week taper
Arm Name:PD 0332334 300 mg BID
Intervention Type:Drug
Name:paroxetine
Description:Capsules, oral, 20 mg q am, 8 weeks, with 2 week taper
Arm Name:Paroxetine 20 mg q am
Intervention Type:Drug
Name:Placebo
Description:Capsules, oral, BID, 8 weeks, with 2 week taper
Arm Name:Placebo BID

Study Arms

Study Arm Type:Experimental
Arm Name:PD 0332334 225 mg BID
Study Arm Type:Experimental
Arm Name:PD 0332334 300 mg BID
Study Arm Type:Active Comparator
Arm Name:Paroxetine 20 mg q am
Study Arm Type:Placebo Comparator
Arm Name:Placebo BID

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Pfizer

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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