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

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ClinicalTrials.gov Identifier: NCT00658762
Recruitment Status : Terminated (Please see Detailed Description for termination reason.)
First Posted : April 15, 2008
Last Update Posted : November 16, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE April 9, 2008
First Posted Date  ICMJE April 15, 2008
Last Update Posted Date November 16, 2012
Study Start Date  ICMJE May 2008
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 9, 2008)
  • Change from Baseline in HAM-A total score at Week 8 [ Time Frame: 8 weeks ]
  • To assess the safety and tolerability of PD 0332334 in subjects with GAD [ Time Frame: 8 weeks with taper ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00658762 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 17, 2008)
  • Response rate on the HAM-A at Week 1 and Week 8 [ Time Frame: 8 weeks ]
  • Remission rate based on the HAM-A at Week 8 [ Time Frame: 8 weeks ]
  • Change from Baseline in the somatic subscale score of the HAM-A (item 7-13) at Week 8 [ Time Frame: 8 weeks ]
  • Change from Baseline to Week 8 on the Medical Outcomes Study - Sleep Scale subscales [ Time Frame: 8 weeks ]
  • Worsening and improvement (from Baseline to Week 8) on the Changes in Sexual Functioning Questionnaire (CSFQ). [ 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 in the HAM-A total score at Weeks 1, 2, 4 and 6) [ Time Frame: 6 weeks ]
  • Response rate on the PGI-C at Week 8 [ Time Frame: 8 weeks ]
  • Response rate on the 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 (MOS-SS) Sleep Disturbance Score [ 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 ]
  • Change from Baseline to Days 2-8 and Weeks 2, 4, 6 and 8 on the GA-VAS (diary) [ Time Frame: 8 weeks ]
  • The "Week 1 Sustained Responser" rate based on the HAM-A [ 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 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 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) Sleep Disturbance Score [ Time Frame: 1 week ]
  • 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 in CGI-S at Week 8 [ Time Frame: 8 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2008)
  • Change from Baseline to Days 2-8 and Weeks 2, 4, 6 and 8 on the GA-VAS (diary) [ 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: 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 Days 2-8 and Weeks 2, 4, 6, 8 on the DAS-A (total score) [ 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 in the 17-item HAM-D total score at Weeks 1, 2, 4, and 8 [ Time Frame: 8 weeks ]
  • Change from Baseline in CGI-S 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 to Week 8 on the Medical Outcomes Study - Sleep Scale subscales [ Time Frame: 8 weeks ]
  • Worsening and improvement (from Baseline to Week 8) on the Changes in Sexual Functioning Questionnaire (CSFQ). [ Time Frame: 8 weeks ]
  • Change from Baseline to Week 8 on the Sheehan Disability Scale (SDS) total score [ Time Frame: 8 weeks ]
  • Response rate on the PGI-C at Week 8 [ 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 8 on the Medical Outcomes Study Sleep Scale (MOS-SS) Sleep Problems Index II. [ 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 ]
  • Change from Baseline in the HAM-A total score at Weeks 1, 2, 4 and 6) [ Time Frame: 6 weeks ]
  • Response rate on the HAM-A at Week 1 and Week 8 [ Time Frame: 8 weeks ]
  • Remission rate based on the HAM-A at Week 8 [ Time Frame: 8 weeks ]
  • Response rate on the CGI-I at Week 1 and Week 8 [ Time Frame: 8 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A 10-week Study Evaluating the Efficacy and Safety of PD 0332334 for the Treatment of Generalized Anxiety Disorder (3)
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Generalized Anxiety Disorder
Intervention  ICMJE
  • Drug: PD 0332334
    Capsules, oral, 225 mg BID, 8 weeks, with 2 week taper
    Other Name: imagabalin
  • Drug: PD 0332334
    Capsules, oral, 300 mg BID, 8 weeks, with 2 week taper
  • Drug: paroxetine
    Capsules, oral, 20 mg q am, 8 weeks, with 2 week taper
  • Drug: Placebo
    Capsules, oral, BID, 8 weeks, with 2 week taper
Study Arms  ICMJE
  • Experimental: PD 0332334 225 mg BID
    Intervention: Drug: PD 0332334
  • Experimental: PD 0332334 300 mg BID
    Intervention: Drug: PD 0332334
  • Active Comparator: Paroxetine 20 mg q am
    Intervention: Drug: paroxetine
  • Placebo Comparator: Placebo BID
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 16, 2010)
286
Original Estimated Enrollment  ICMJE
 (submitted: April 9, 2008)
528
Actual Study Completion Date  ICMJE April 2009
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hungary,   United States
Removed Location Countries Taiwan
 
Administrative Information
NCT Number  ICMJE NCT00658762
Other Study ID Numbers  ICMJE A5361020
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP