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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
United States, Alabama
Pfizer Investigational Site
Birmingham, Alabama, United States, 35226
United States, Arizona
Pfizer Investigational Site
Litchfield Park, Arizona, United States, 85340
United States, California
Pfizer Investigational Site
Arcadia, California, United States, 91007-3462
Pfizer Investigational Site
Beverly Hills, California, United States, 90210
Pfizer Investigational Site
Costa Mesa, California, United States, 92626
Pfizer Investigational Site
Costa Mesa, California, United States, 92627
Pfizer Investigational Site
Encino, California, United States, 91316
Pfizer Investigational Site
Escondido, California, United States, 92025
Pfizer Investigational Site
Murrieta, California, United States, 92562
Pfizer Investigational Site
National City, California, United States, 91950
Pfizer Investigational Site
Newport Beach, California, United States, 92660-2452
Pfizer Investigational Site
Orange, California, United States, 92868
Pfizer Investigational Site
Pasadena, California, United States, 91106
Pfizer Investigational Site
Redlands, California, United States, 92374
Pfizer Investigational Site
San Diego, California, United States, 92103
Pfizer Investigational Site
San Diego, California, United States, 92108
Pfizer Investigational Site
Sherman Oaks, California, United States, 91403
Pfizer Investigational Site
Temecula, California, United States, 92591
Pfizer Investigational Site
Upland, California, United States, 91786
Pfizer Investigational Site
Wildomar, California, United States, 92595
United States, Colorado
Pfizer Investigational Site
Denver, Colorado, United States, 80239
United States, Connecticut
Pfizer Investigational Site
Hamden, Connecticut, United States, 06518
Pfizer Investigational Site
Norwich, Connecticut, United States, 06360
United States, Florida
Pfizer Investigational Site
Altamonte Springs, Florida, United States, 32701
Pfizer Investigational Site
Ft. Myers, Florida, United States, 33912
Pfizer Investigational Site
Jacksonville, Florida, United States, 32216
Pfizer Investigational Site
Maitland, Florida, United States, 32751
Pfizer Investigational Site
Miami, Florida, United States, 33126
Pfizer Investigational Site
Miami, Florida, United States, 33143
Pfizer Investigational Site
Orange City, Florida, United States, 32763
Pfizer Investigational Site
Orlando, Florida, United States, 32806
Pfizer Investigational Site
South Miami, Florida, United States, 33143
Pfizer Investigational Site
West Palm Beach, Florida, United States, 33407
United States, Georgia
Pfizer Investigational Site
Atlanta, Georgia, United States, 30308
Pfizer Investigational Site
Atlanta, Georgia, United States, 30328
Pfizer Investigational Site
Marietta, Georgia, United States, 30060
United States, Illinois
Pfizer Investigational Site
Libertyville, Illinois, United States, 60048
Pfizer Investigational Site
Naperville, Illinois, United States, 60563
Pfizer Investigational Site
Park Ridge, Illinois, United States, 60068
United States, Indiana
Pfizer Investigational Site
Greenwood, Indiana, United States, 46143
Pfizer Investigational Site
Terre Haute, Indiana, United States, 47802
United States, Kansas
Pfizer Investigational Site
Overland Park, Kansas, United States, 66212
Pfizer Investigational Site
Prairie Village, Kansas, United States, 66206
Pfizer Investigational Site
Wichita, Kansas, United States, 67207
United States, Kentucky
Pfizer Investigational Site
Owensboro, Kentucky, United States, 42301
United States, Louisiana
Pfizer Investigational Site
Lake Charles, Louisiana, United States, 70601
United States, Maryland
Pfizer Investigational Site
Baltimore, Maryland, United States, 21208
United States, Massachusetts
Pfizer Investigational Site
Belmont, Massachusetts, United States, 02478
Pfizer Investigational Site
Boston, Massachusetts, United States, 02135
Pfizer Investigational Site
Fall River, Massachusetts, United States, 02721
Pfizer Investigational Site
Haverhill, Massachusetts, United States, 01830
Pfizer Investigational Site
Pittsfield, Massachusetts, United States, 01201
United States, Nebraska
Pfizer Investigational Site
Omaha, Nebraska, United States, 68131
United States, Nevada
Pfizer Investigational Site
Las Vegas, Nevada, United States, 89146
United States, New Hampshire
Pfizer Investigational Site
Nashua, New Hampshire, United States, 03060
United States, New Mexico
Pfizer Investigational Site
Albuquerque, New Mexico, United States, 87109
United States, New York
Pfizer Investigational Site
Bronx, New York, United States, 10467
Pfizer Investigational Site
Brooklyn, New York, United States, 11235
Pfizer Investigational Site
New York, New York, United States, 10024
Pfizer Investigational Site
New York, New York, United States, 10023
Pfizer Investigational Site
New York, New York, United States, 10128-1708
Pfizer Investigational Site
Rochester, New York, United States, 14618
United States, North Carolina
Pfizer Investigational Site
Raleigh, North Carolina, United States, 27607
United States, Ohio
Pfizer Investigational Site
Columbus, Ohio, United States, 43210
Pfizer Investigational Site
Dayton, Ohio, United States, 45408
Pfizer Investigational Site
Toledo, Ohio, United States, 43609
Pfizer Investigational Site
Toledo, Ohio, United States, 43623
United States, Oklahoma
Pfizer Investigational Site
Bethany, Oklahoma, United States, 73008
Pfizer Investigational Site
Oklahoma City, Oklahoma, United States, 73103
Pfizer Investigational Site
Oklahoma City, Oklahoma, United States, 73116
United States, Oregon
Pfizer Investigational Site
Portland, Oregon, United States, 97210
Pfizer Investigational Site
Salem, Oregon, United States, 97301
United States, Pennsylvania
Pfizer Investigational Site
Allentown, Pennsylvania, United States, 18104
Pfizer Investigational Site
Media, Pennsylvania, United States, 19063
Pfizer Investigational Site
Norristown, Pennsylvania, United States, 19401
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19139
United States, Rhode Island
Pfizer Investigational Site
Lincoln, Rhode Island, United States, 02865
United States, South Carolina
Pfizer Investigational Site
Columbia, South Carolina, United States, 29201
United States, Tennessee
Pfizer Investigational Site
Memphis, Tennessee, United States, 38119
Pfizer Investigational Site
Memphis, Tennessee, United States, 38134
United States, Texas
Pfizer Investigational Site
Austin, Texas, United States, 78756
Pfizer Investigational Site
Dallas, Texas, United States, 75231
Pfizer Investigational Site
Dallas, Texas, United States, 75230
Pfizer Investigational Site
DeSoto, Texas, United States, 75115
Pfizer Investigational Site
Houston, Texas, United States, 77074
Pfizer Investigational Site
Houston, Texas, United States, 77008
Pfizer Investigational Site
Lake Jackson, Texas, United States, 77566
Pfizer Investigational Site
San Antonio, Texas, United States, 78229
United States, Vermont
Pfizer Investigational Site
Woodstock, Vermont, United States, 05091
United States, Virginia
Pfizer Investigational Site
Charlottesville, Virginia, United States, 22903
United States, Washington
Pfizer Investigational Site
Seattle, Washington, United States, 98104
United States, Wisconsin
Pfizer Investigational Site
Middleton, Wisconsin, United States, 53562
Pfizer Investigational Site
Waukesha, Wisconsin, United States, 53188-1660
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
Disease
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014