A 52-Week Open-Label Safety Study of PD 0332334 in Subjects With Generalized Anxiety Disorder (GAD)

This study has been terminated.
(Please see Detailed Description for termination reason.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00735267
First received: August 12, 2008
Last updated: November 9, 2012
Last verified: November 2012

August 12, 2008
November 9, 2012
October 2008
April 2009   (final data collection date for primary outcome measure)
  • The nature, incidence, and duration of adverse events monitored throughout the study by physical exam [ Time Frame: Screening, Wk 25 & Wk 52/EOT ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • The Columbia Suicide Severity Rating scale will be used to assess any suicide related adverse events [ Time Frame: As needed ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • All discontinuations due to adverse events will be reviewed throughout the trial to assess the safety and tolerability of the compound [ Time Frame: Weekly ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • The Columbia Suicide Severity Rating scale will be used to assess any suicide related adverse events [ Time Frame: As needed ] [ Designated as safety issue: Yes ]
  • All discontinuations due to adverse events will be reviewed throughout the trial to assess the safety and tolerability of the compound [ Time Frame: Weekly ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00735267 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • The Health Care Utilization Questionnaire will be utilized to assess overall Health Care over a one year time period. [ Time Frame: 2-6 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A 52-Week Open-Label Safety Study of PD 0332334 in Subjects With Generalized Anxiety Disorder (GAD)
A 52-Week Open-Label Safety Study of PD 0332334 in Subjects With Generalized Anxiety Disorder

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.

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.

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Generalized Anxiety Disorder
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
468
April 2009
April 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00735267
A5361022
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2012

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