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A 10-week Study Evaluating the Efficacy and Safety of PD 0332334 for the Treatment of Generalized Anxiety Disorder (3)

Last updated on November 13, 2019

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Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35226 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Generalized Anxiety Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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 diagnoses: 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.

NCT00658762
Pfizer
Terminated
A 10-week Study Evaluating the Efficacy and Safety of PD 0332334 for the Treatment of Generalized Anxiety Disorder (3)

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Descriptive Information
Brief Title  ICMJE A 10-week Study Evaluating the Efficacy and Safety of PD 0332334 for the Treatment of Generalized Anxiety Disorder (3)
Official Title  ICMJE 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
Brief SummaryThis is a 10-week trial that evaluates the efficacy and safety of PD 0332334 in subjects ages 18 and older with generalized anxiety disorder.
Detailed DescriptionTermination 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Generalized Anxiety Disorder
Intervention  ICMJE
  • Drug: PD 0332334
    Capsules, oral, 225 mg BID, 8 weeks, with 2 week taper
    Other Name: imagabalin
  • Drug: PD 0332334
    Capsules, oral, 300 mg BID, 8 weeks, with 2 week taper
  • Drug: paroxetine
    Capsules, oral, 20 mg q am, 8 weeks, with 2 week taper
  • Drug: Placebo
    Capsules, oral, BID, 8 weeks, with 2 week taper
Study Arms  ICMJE
  • Experimental: PD 0332334 225 mg BID
    Intervention: Drug: PD 0332334
  • Experimental: PD 0332334 300 mg BID
    Intervention: Drug: PD 0332334
  • Active Comparator: Paroxetine 20 mg q am
    Intervention: Drug: paroxetine
  • Placebo Comparator: Placebo BID
    Intervention: Drug: Placebo
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 16, 2010)
286
Original Estimated Enrollment  ICMJE
 (submitted: April 9, 2008)
528
Actual Study Completion Date  ICMJE April 2009
Actual Primary Completion DateApril 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

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 diagnoses: 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hungary,   United States
Removed Location CountriesTaiwan
 
Administrative Information
NCT Number  ICMJE NCT00658762
Other Study ID Numbers  ICMJE A5361020
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateNovember 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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