6-Month Open-Label Safety Study Of PD 0332334 In Elderly Patients With Generalized Anxiety Disorder (GAD)

This study has been withdrawn prior to enrollment.
(Please see Detailed Description for termination reason.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00738738
First received: August 12, 2008
Last updated: November 30, 2012
Last verified: November 2012
  Purpose

This is an open-label, multi-site, 6-month study of an investigational compound in elderly outpatients, age 65 years old or above, to assess the long-term safety and tolerability of the compound in the treatment of elderly subjects with Generalized Anxiety Disorder (GAD).


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 Phase 3, 6-Month Open-Label Safety Study Of PD 0332334 In Elderly Patients With Generalized Anxiety Disorder

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Discontinuations due to adverse events or adverse events occurring during and after the discontinuation of trial medication [ Time Frame: Weekly ] [ Designated as safety issue: Yes ]
  • The nature, incidence, duration, and severity of adverse events. [ Time Frame: Weekly ] [ Designated as safety issue: Yes ]
  • Suicide related adverse events will be further assessed using the Columbia Suicide Severity Rating Scale as needed [ Time Frame: As needed ] [ Designated as safety issue: Yes ]
  • The primary outcome is safety which will be assessed throughout the 6-months by physical exams, monitoring of vital signs, body weight changes, and clinical safety laboratory [ Time Frame: Screening, Baseline, Wk 4, Wk 14, Wk 26/EOT, & at FU; Vital signs at every vist ] [ Designated as safety issue: Yes ]
  • Electrocardiograms will be performed to assess any changes in cardiac functioning related to the compound [ Time Frame: Screening, Baseline, Wk 4, Wk 15 & Wk 26/EOT ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Symptom severity of generalized Anxiety Disorder (GAD) will be measured by the Hamilton Rating Scale for Anxiety (HAM-A). [ Time Frame: Screening, Baseline, Wk 1-2, Wk 4, Wk 14, Wk 26/EOT & Wk 27 (FU) ] [ Designated as safety issue: No ]
  • Overall Health Care utilization will be assessed with the Health Care Utilization (HCU) questionnaire. [ Time Frame: Twice at Wk 13 and Wk 26/EOT ] [ Designated as safety issue: No ]
  • Also, the Daily Diary (including the Daily assessment of Symptoms DAS-A and Global Anxiety - Visual Analog Scale (GA-VAS) and the Clinical Global Impression of Severity (CGI-S) will be used to assess symptoms of GAD. [ Time Frame: Screening, Baseline, Wk 1-2, Wk 4, Wk 14, Wk 26/EOT ] [ Designated as safety issue: No ]
  • Plasma concentrations will be collected to evaluate the population pharmacokinetics and the dose/exposure relationships for safety and efficacy . [ Time Frame: 1 time ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: January 2009
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: PD-0332334
    Dosage from: 50-100 mg oral capsule Dosage and frequency: 50-350 mg once or twice a day Duration: 6 months
    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:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men or women age > 65 years.
  • A primary diagnosis of Generalized Anxiety Disorder according to the Diagnostic and Statistical Manual-IV (DSM-IV).
  • Subjects must have a HAM-A score of 16 or higher at both screening and baseline visits.

Exclusion Criteria:

  • Women who are pregnant or contemplating pregnancy (eg, via in vitro fertilization) during the study through 30 days after the last dose of study medication.
  • Subjects with evidence of a current (within the past 6 months) clinically significant or unstable hematological, autoimmune, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, pancreatic, psychiatric, neurologic, immunological or retinal disorder; subjects with an active infection within the past 2 months.
  • Subjects who have an ongoing, unresolved, clinically significant cardiovascular or cerebrovascular medical problem.
  • Mini Mental Status Exam (MMSE) score <24 or possibility of undiagnosed dementia, cognitive or amnestic disorder, including, but not limited to mild cognitive impairment.
  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: NCT00738738

Locations
United States, Florida
Pfizer Investigational Site
Orlando, Florida, United States, 32806
United States, Kansas
Pfizer Investigational Site
Prairie Village, Kansas, United States, 66206
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00738738     History of Changes
Other Study ID Numbers: A5361036
Study First Received: August 12, 2008
Last Updated: November 30, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Generalized Anxiety Disorder Elderly

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

ClinicalTrials.gov processed this record on September 22, 2014