A 5-Week Trial Of PD 0332334 And Alprazolam Extended Rele... | NCT00921063

Studies
A 5-Week Trial Of PD 0332334 And Alprazolam Extended Release Compared To Placebo In Patients With Generalized Anxiety Disorder

NCT00921063

Sponsor

Pfizer

Status

Completed

Last Update Posted

Feb 19, 2010Estimated

Enrollment

222Actual

Phase

Phase 2

Conditions

Generalized Anxiety Disorder

Interventions

PD 0332334
PD 0332334
placebo
Alprazolam extended release

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2005

Primary Completion Date

Jul 2006Actual

Completion Date

Jul 2006Actual

First Submitted Date

Jun 15, 2009

First Submission Date that Met QC Criteria

Jun 15, 2009

First Posted Date

Jun 16, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 17, 2010

Last Update Posted Date

Feb 19, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of PD 0332334 compared to placebo in the treatment of Generalized Anxiety Disorder in an adult population

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

222Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
PD 0332334 250 mg	Experimental	Drug: PD 0332334
PD 0332334 100 mg	Experimental	Drug: PD 0332334
placebo	Placebo Comparator	Drug: placebo
Alprazolam extended release	Active Comparator	Drug: Alprazolam extended release

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PD 0332334	Drug	250 mg capsule, BID for 4 weeks	PD 0332334 250 mg	imagabalin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
HAM-A Total Score		4 weeks

Secondary Outcomes

Measure	Description	Time Frame
HAM-A total score at week 1, 2 and 4		1. 2. ands 4 weeks
HAM-A somatic and psychic subscales		1, 2, and 4 weeks
HAM-A responders

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy males or females with a diagnosis of Generalized Anxiety Disorder (GAD) (Diagnostic and Statistical Manual-IV [DSM-IV], 300.02).
HAM-A Total Score ≥20 and item #1 on the HAM-D (depressed mood score) ≤2 at both Screening and Baseline/Randomization.

Exclusion Criteria:

Current diagnoses (within the 6 months) of Major Depressive Disorder; Obsessive Compulsive Disorder; Panic Disorder; Posttraumatic Stress Disorder; Anorexia; Bulimia; Caffeine-induced anxiety disorder;
Any of the following past or current diagnoses: Schizophrenia; Psychotic Disorder; Delirium, Dementia, Bipolar or Schizoaffective Disorder; Cyclothymic Disorder; Dissociative Disorders; Antisocial or borderline personality disorder
Current use of psychotropic medications (i.e., drugs normally prescribed for depression, mania, anxiety, insomnia, or psychosis) that could not be discontinued 2 weeks prior to dosing.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Label	URL
To obtain contact information for a study center near you, click here.	View source

Condition Browse Module

MeSH Terms

ID	Term
D000098647	Generalized Anxiety Disorder

Ancestor Terms

ID	Term
D001008	Anxiety Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C583768	imagabalin
D000525	Alprazolam

Ancestor Terms

ID	Term
D001569	Benzodiazepines
D001552	Benzazepines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Browse Leaves

Not provided

Browse Branches

Not provided