Back to results6-Month Open-Label Safety Study Of PD 0332334 In Elderly Patients With Generalized Anxiety Disorder (GAD)
Primary Purpose
Generalized Anxiety Disorder
Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
PD-0332334
Sponsored by
About this trial
This is an interventional treatment trial for Generalized Anxiety Disorder focused on measuring Generalized Anxiety Disorder Elderly
Eligibility 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.
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
Outcomes
Primary Outcome Measures
Discontinuations due to adverse events or adverse events occurring during and after the discontinuation of trial medication
The nature, incidence, duration, and severity of adverse events.
Suicide related adverse events will be further assessed using the Columbia Suicide Severity Rating Scale as needed
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
Electrocardiograms will be performed to assess any changes in cardiac functioning related to the compound
Secondary Outcome Measures
Symptom severity of generalized Anxiety Disorder (GAD) will be measured by the Hamilton Rating Scale for Anxiety (HAM-A).
Overall Health Care utilization will be assessed with the Health Care Utilization (HCU) questionnaire.
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.
Plasma concentrations will be collected to evaluate the population pharmacokinetics and the dose/exposure relationships for safety and efficacy .
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00738738
Brief Title
6-Month Open-Label Safety Study Of PD 0332334 In Elderly Patients With Generalized Anxiety Disorder (GAD)
Official Title
A Phase 3, 6-Month Open-Label Safety Study Of PD 0332334 In Elderly Patients With Generalized Anxiety Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Withdrawn
Why Stopped
Please see Detailed Description for termination reason.
Study Start Date
January 2009 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder
Keywords
Generalized Anxiety Disorder Elderly
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
PD-0332334
Other Intervention Name(s)
imagabalin
Intervention Description
Dosage from: 50-100 mg oral capsule Dosage and frequency: 50-350 mg once or twice a day Duration: 6 months
Primary Outcome Measure Information:
Title
Discontinuations due to adverse events or adverse events occurring during and after the discontinuation of trial medication
Time Frame
Weekly
Title
The nature, incidence, duration, and severity of adverse events.
Time Frame
Weekly
Title
Suicide related adverse events will be further assessed using the Columbia Suicide Severity Rating Scale as needed
Time Frame
As needed
Title
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
Title
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
Secondary Outcome Measure Information:
Title
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)
Title
Overall Health Care utilization will be assessed with the Health Care Utilization (HCU) questionnaire.
Time Frame
Twice at Wk 13 and Wk 26/EOT
Title
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
Title
Plasma concentrations will be collected to evaluate the population pharmacokinetics and the dose/exposure relationships for safety and efficacy .
Time Frame
1 time
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Pfizer Investigational Site
City
Prairie Village
State/Province
Kansas
ZIP/Postal Code
66206
Country
United States
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5361036&StudyName=6-Month%20Open-Label%20Safety%20Study%20Of%20PD%200332334%20In%20Elderly%20Patients%20With%20Generalized%20Anxiety%20Disorder%20%28GAD%29
Description
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Learn more about this trial
6-Month Open-Label Safety Study Of PD 0332334 In Elderly Patients With Generalized Anxiety Disorder (GAD)
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