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This study has been withdrawn prior to enrollment.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:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00738738
First received: August 12, 2008
Last updated: November 30, 2012
Last verified: November 2012
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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:
Detailed Description:
-
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
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
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 Mental Disorders |
ClinicalTrials.gov processed this record on May 23, 2013