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

This study has been terminated.
(Please see Detailed Description for termination reason.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00658372
First received: April 9, 2008
Last updated: November 9, 2012
Last verified: November 2012
  Purpose

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 Intervention Phase
Generalized Anxiety Disorder
Drug: PD 0332334
Drug: Paroxetine
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • The safety and tolerability of PD 0332334 in subjects with GAD will be monitored in this study [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Average (across the week 1, 2, 4, 6 and 8 visits) HAM-A change from baseline score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in the HAM-A total score at weeks 1, 2, 4, and 6 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline to Week 8 on the Medical Outcomes Study Sleep Scale subscales [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Response rate on the patient-rated PGI-C at week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change from Baseline to Days 2- 8 and Weeks 2, 4, 6, 8 on the DAS A (total score) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline to Week 8 on the Medical Outcomes Study Sleep Scale (MOS SS) Sleep Disturbance Score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Response rate on the HAM-A at week 1 and week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline to Week 1 on the Medical Outcomes Study Sleep Scale (MOS SS) Sleep Disturbance Score [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Change from baseline in the 17-item HAM-D total score at weeks 1, 2, 4, and 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in the psychic subscale score of the HAM A (Items 1- 6 and 14) at Week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in the somatic subscale score of the HAM-A (items 7 - 13) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to week 8 in the QLesQ General Activity Score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Worsening and improvement from baseline to week 8 on the changes in the Sexual Functioning Questionnaire (CSFQ) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Remission rate based on the HAM A at Week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Response rate on the clinician-rated CGI-I ate week 1 and week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in CGI-S at week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to Days 2-8 and weeks 2, 4, 6 and 8 on the GA-VAS (diary) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to week 8 on the Sheehan Disability Scale (SDS) total score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 360
Study Start Date: May 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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.
  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: NCT00658372

  Show 33 Study Locations
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: NCT00658372     History of Changes
Other Study ID Numbers: A5361018
Study First Received: April 9, 2008
Last Updated: November 9, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
PD 0332334 phase 3 pivotal trial

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Paroxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 21, 2014