Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A 10-week Study Evaluating the Efficacy and Safety of PD 0332334 in Patients With Generalized Anxiety Disorder (2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00658372
Recruitment Status : Terminated (Please see Detailed Description for termination reason.)
First Posted : April 15, 2008
Last Update Posted : November 16, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
This is a 10-week trial that evaluates the efficacy and safety of PD 0332334 in subjects, ages 18 to 65, with generalized anxiety disorder.

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

Detailed Description:
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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind, Parallel Group, 10-Week Placebo Controlled Fixed Dose Study Of PD 0332334 And Paroxetine Evaluating The Efficacy And Safety Of PD 0332334 For The Treatment Of Generalized Anxiety Disorder
Study Start Date : May 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: PD 0332334 225 mg BID Drug: PD 0332334
Capsules, oral, 225 mg BID, 8 weeks with 2 week taper
Other Name: imagabalin

Experimental: PD 0332334 300 mg BID Drug: PD 0332334
Capsules, oral, 300 mg BID, 8 weeks with 2 week taper

Active Comparator: Paroxetine 20 mg QD Drug: Paroxetine
Capsules, oral, Paroxetine, 20 mg QD, 8 weeks with 2 week taper

Placebo Comparator: Placebo BID Drug: Placebo
Capsules, oral, placebo, BID, 8 weeks with 2 week taper




Primary Outcome Measures :
  1. The efficacy of PD 0332334 in the treatment of GAD will be measured by the change in the Hamilton Anxiety Rating Scale (HAM-A) total scores from baseline observed following 8 weeks of double-blind treatment. [ Time Frame: 8 weeks ]
  2. The safety and tolerability of PD 0332334 in subjects with GAD will be monitored in this study [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Average (across the week 1, 2, 4, 6 and 8 visits) HAM-A change from baseline score [ Time Frame: 8 weeks ]
  2. Change from baseline in the HAM-A total score at weeks 1, 2, 4, and 6 [ Time Frame: 6 weeks ]
  3. Change from Baseline to Week 8 on the Medical Outcomes Study Sleep Scale subscales [ Time Frame: 8 weeks ]
  4. Response rate on the patient-rated PGI-C at week 8 [ Time Frame: 8 weeks ]
  5. The "Week 1 Sustained Responder" rate based on the HAM A (where "Week 1 Sustained Responders" are defined as subjects with a 50% or greater improvement from baseline on the HAM A total score at Week 1 that is sustained until the Week 8 visit) [ Time Frame: 1 week ]
  6. Change from Baseline to Days 2- 8 and Weeks 2, 4, 6, 8 on the DAS A (total score) [ Time Frame: 8 weeks ]
  7. Change from Baseline to Week 8 on the Medical Outcomes Study Sleep Scale (MOS SS) Sleep Disturbance Score [ Time Frame: 8 weeks ]
  8. Response rate on the HAM-A at week 1 and week 8 [ Time Frame: 8 weeks ]
  9. Change from Baseline to Week 1 on the Medical Outcomes Study Sleep Scale (MOS SS) Sleep Disturbance Score [ Time Frame: 1 week ]
  10. Change from baseline in the 17-item HAM-D total score at weeks 1, 2, 4, and 8 [ Time Frame: 8 weeks ]
  11. Change from Baseline in the psychic subscale score of the HAM A (Items 1- 6 and 14) at Week 8 [ Time Frame: 8 weeks ]
  12. Change from baseline in the somatic subscale score of the HAM-A (items 7 - 13) [ Time Frame: 8 weeks ]
  13. Change from baseline to week 8 in the QLesQ General Activity Score [ Time Frame: 8 weeks ]
  14. Worsening and improvement from baseline to week 8 on the changes in the Sexual Functioning Questionnaire (CSFQ) [ Time Frame: 8 weeks ]
  15. Remission rate based on the HAM A at Week 8 [ Time Frame: 8 weeks ]
  16. Response rate on the clinician-rated CGI-I ate week 1 and week 8 [ Time Frame: 8 weeks ]
  17. Change from baseline in CGI-S at week 8 [ Time Frame: 8 weeks ]
  18. Change from baseline to Days 2-8 and weeks 2, 4, 6 and 8 on the GA-VAS (diary) [ Time Frame: 8 weeks ]
  19. Change from baseline to week 8 on the Sheehan Disability Scale (SDS) total score [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of GAD (Diagnostic and Statistical Manual IV [DSM IV], 300.02) as established by the clinician (psychiatrist or licensed clinical psychologist) who has interviewed the subject using all sources of data including the Mini International Neuropsychiatric Interview (MINI) for DSM IV Axis I disorders and other clinical information. Subjects with specific phobia(s) (as defined in DSM IV) or dysthymic disorder will be allowed in the study.
  • Subjects must have a HAM A total score ≥20 at the screening (V1) and randomization (V2) visits. Subjects must also have a Covi Anxiety Scale score of ≥9 and a Raskin Depression Scale score ≤7 at the Screening (V1) visit to ensure predominance of anxiety symptoms over depression symptoms.

Exclusion Criteria:

  • Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, pancreatic, neurologic, active infections, immunological, or allergic disease (including drug allergies).
  • Any of the following current (within the past 6 months through the present) DSM-IV Axis I diagnosis: Major Depressive Disorder, Obsessive Compulsive Disorder, Panic Disorder, Agoraphobia, Posttraumatic Stress Disorder, Anorexia, Bulimia, Caffeine induced anxiety disorder, Alcohol or substance abuse or dependence unless in full remission for at least 6 months, Social anxiety disorder.
  • Any of the following past or current DSM-IV Axis I diagnoses: Schizophrenia, Psychotic disorder, Delirium, dementia, amnestic, and other clinically significant cognitive disorders, Bipolar or schizoaffective disorder, Cyclothymic disorder, Dissociative disorders.
  • Antisocial or borderline personality disorder.
  • Serious suicidal risk per the clinical investigator's judgment.

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): NCT00658372


Locations
Layout table for location information
United States, California
Pfizer Investigational Site
Arcadia, California, United States, 91007-3462
Pfizer Investigational Site
Costa Mesa, California, United States, 92627
Pfizer Investigational Site
Escondido, California, United States, 92025
Pfizer Investigational Site
Los Angeles, California, United States, 90048
Pfizer Investigational Site
San Diego, California, United States, 92108
United States, Connecticut
Pfizer Investigational Site
Hamden, Connecticut, United States, 06518
United States, Florida
Pfizer Investigational Site
Boca Raton, Florida, United States, 33431
United States, Hawaii
Pfizer Investigational Site
Honolulu, Hawaii, United States, 96813
United States, Illinois
Pfizer Investigational Site
Naperville, Illinois, United States, 60563
Pfizer Investigational Site
Park Ridge, Illinois, United States, 60068
United States, Kansas
Pfizer Investigational Site
Prairie Village, Kansas, United States, 66206
United States, Louisiana
Pfizer Investigational Site
New Orleans, Louisiana, United States, 70115
United States, Massachusetts
Pfizer Investigational Site
Haverhill, Massachusetts, United States, 01830
Pfizer Investigational Site
Pittsfield, Massachusetts, United States, 01201
United States, Michigan
Pfizer Investigational Site
Flint, Michigan, United States, 48503
Pfizer Investigational Site
Flint, Michigan, United States, 48532
United States, Minnesota
Pfizer Investigational Site
Minneapolis, Minnesota, United States, 55454
Pfizer Investigational Site
St. Paul, Minnesota, United States, 55101
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10128-1708
Pfizer Investigational Site
Olean, New York, United States, 14760
Pfizer Investigational Site
Rochester, New York, United States, 14618
United States, Ohio
Pfizer Investigational Site
Dayton, Ohio, United States, 45408
United States, Pennsylvania
Pfizer Investigational Site
Allentown, Pennsylvania, United States, 18104
United States, Tennessee
Pfizer Investigational Site
Bartlett, Tennessee, United States, 38134
Pfizer Investigational Site
Memphis, Tennessee, United States, 38119
United States, Texas
Pfizer Investigational Site
Dallas, Texas, United States, 75230
Pfizer Investigational Site
DeSoto, Texas, United States, 75115
Pfizer Investigational Site
Houston, Texas, United States, 77090
United States, Utah
Pfizer Investigational Site
Salt Lake City, Utah, United States, 84132
Hungary
Pfizer Investigational Site
Budapest, Hungary, 1212
Russian Federation
Pfizer Investigational Site
Moscow, Russian Federation, 125367
Pfizer Investigational Site
St. Petersburg, Russian Federation, 191180
Taiwan
Pfizer Investigational Site
Tainan, Taiwan, 704
Sponsors and Collaborators
Pfizer
Investigators
Layout table for investigator information
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00658372    
Other Study ID Numbers: A5361018
First Posted: April 15, 2008    Key Record Dates
Last Update Posted: November 16, 2012
Last Verified: November 2012
Keywords provided by Pfizer:
PD 0332334 phase 3 pivotal trial
Additional relevant MeSH terms:
Layout table for MeSH terms
Anxiety Disorders
Mental Disorders
Paroxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors