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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

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.

Condition or disease Intervention/treatment Phase
Generalized Anxiety Disorder Drug: PD 0332334 Phase 3

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 : Interventional  (Clinical Trial)
Actual Enrollment : 468 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 52-Week Open-Label Safety Study of PD 0332334 in Subjects With Generalized Anxiety Disorder
Study Start Date : October 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources


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


Primary Outcome Measures :
  1. The nature, incidence, and duration of adverse events monitored throughout the study by physical exam [ Time Frame: Screening, Wk 25 & Wk 52/EOT ]
  2. 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 ]
  3. The Columbia Suicide Severity Rating scale will be used to assess any suicide related adverse events [ Time Frame: As needed ]
  4. 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 ]
  5. All discontinuations due to adverse events will be reviewed throughout the trial to assess the safety and tolerability of the compound [ Time Frame: Weekly ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00735267


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

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00735267     History of Changes
Other Study ID Numbers: A5361022
First Posted: August 14, 2008    Key Record Dates
Last Update Posted: November 16, 2012
Last Verified: November 2012

Keywords provided by Pfizer:
Generalized Anxiety Disorder

Additional relevant MeSH terms:
Disease
Anxiety Disorders
Pathologic Processes
Mental Disorders