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
  Purpose

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.


Condition Intervention Phase
Generalized Anxiety Disorder
Drug: PD 0332334
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A 52-Week Open-Label Safety Study of PD 0332334 in Subjects With Generalized Anxiety Disorder

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 468
Study Start Date: October 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00735267

  Show 93 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00735267     History of Changes
Other Study ID Numbers: A5361022
Study First Received: August 12, 2008
Last Updated: November 9, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Generalized Anxiety Disorder

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014