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Trial record 1 of 1 for:    NCT00735267
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A 52-Week Open-Label Safety Study of PD 0332334 in Subjects With Generalized Anxiety Disorder (GAD)

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ClinicalTrials.gov Identifier: NCT00735267
Recruitment Status : Terminated (Please see Detailed Description for termination reason.)
First Posted : August 14, 2008
Last Update Posted : November 16, 2012
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE August 12, 2008
First Posted Date  ICMJE August 14, 2008
Last Update Posted Date November 16, 2012
Study Start Date  ICMJE October 2008
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 16, 2008)
  • The nature, incidence, and duration of adverse events monitored throughout the study by physical exam [ Time Frame: Screening, Wk 25 & Wk 52/EOT ]
  • Electrocardiogram will be performed at screening and during follow up visits to assess the safety and tolerability of the compound in terms of clinically significant cardiovascular changes [ Time Frame: Screening, Wk 4, Wk 25, Wk 52/EOT ]
  • The Columbia Suicide Severity Rating scale will be used to assess any suicide related adverse events [ Time Frame: As needed ]
  • The nature, incidence, and duration of adverse events monitored throughout the study by vital signs evaluation at each visit, weight measurements and clinical laboratory monitoring periodically [ Time Frame: Screening, Baseline, Wk 4, Wk 12, Wk 25, Wk 38, & Wk 52/EOT ]
  • All discontinuations due to adverse events will be reviewed throughout the trial to assess the safety and tolerability of the compound [ Time Frame: Weekly ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 13, 2008)
  • The nature, incidence, and duration of adverse events monitored throughout the study by clinical laboratory monitoring, physical exam, vital signs and weight measurements [ Time Frame: 2-13 weeks ]
  • Electrocardiogram will be performed at screening and during follow up visits to assess the safety and tolerability of the compound in terms of clinically significant cardiovascular changes [ Time Frame: 26 weeks ]
  • All discontinuations due to adverse events will be reviewed throughout the trial to assess the safety and tolerability of the compound [ Time Frame: Weekly ]
  • The Columbia Suicide Severity Rating scale will be used to assess any suicide related adverse events [ Time Frame: As needed ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2008)
  • The Hamilton Rating Scale for Anxiety (HAM-A) will be used to assess symptoms of Generalized Anxiety Disorder (GAD) over a one year time period. [ Time Frame: Baseline, Wk 12, Wk 25, Wk 38, Wk 51 & Wk 52/EOT ]
  • The Clinical Global Impression of Severity (CGI-S), and the Daily Diary (DD) will also be used to assess symptoms of GAD over a one year time period. [ Time Frame: Baseline, Wk 51 & Wk 52/EOT ]
  • The Health Care Utilization Questionnaire will be utilized to assess overall Health Care over a one year time period. [ Time Frame: Baseline, Wk 12, Wk 25, Wk 38 & Wk 51 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 13, 2008)
  • The Health Care Utilization Questionnaire will be utilized to assess overall Health Care over a one year time period. [ Time Frame: 2-6 weeks ]
  • The Hamilton Rating Scale for Anxiety (HAM-A) will be used to assess symptoms of Generalized Anxiety Disorder (GAD) over a one year time period. [ Time Frame: 2-6 weeks ]
  • The Clinical Global Impression of Severity (CGI-S), and the Daily Diary (DD) will also be used to assess symptoms of GAD over a one year time period. [ Time Frame: 50 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A 52-Week Open-Label Safety Study of PD 0332334 in Subjects With Generalized Anxiety Disorder (GAD)
Official Title  ICMJE A 52-Week Open-Label Safety Study of PD 0332334 in Subjects With Generalized Anxiety Disorder
Brief Summary This study will assess the long-term safety and tolerability of 350 to 600 mg/day of PD 0332334 administered in split dose (twice daily) in subjects 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Generalized Anxiety Disorder
Intervention  ICMJE Drug: PD 0332334
Dosage Form: 25 or 100 mg oral capsules Dosage and frequency: 350-600 mg twice a day Duration: 1 year
Other Name: imagabalin
Study Arms  ICMJE Not Provided
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: July 20, 2009)
468
Original Estimated Enrollment  ICMJE
 (submitted: August 13, 2008)
760
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:

  • Subjects must have completed all phases of one of the four preceding double-blind GAD studies.
  • Female must continue to use adequate birth control methods and have a negative serum pregnancy test within 14 days prior to starting open label treatment.

Exclusion Criteria:

  • Subjects who experienced a serious adverse event during the preceding double-blind efficacy study that was judged to be related to study medication by the investigator or the sponsor's medical monitor.
  • Individuals who have an ongoing, unresolved, clinically significant medical problem that, in the judgment of the investigator or the sponsor's medical monitor, would make it unsafe for the subject to participate in the study.
  • Serious suicidal risk per the clinical investigators's judgement.
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00735267
Other Study ID Numbers  ICMJE A5361022
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
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