Safety and Efficacy Evaluation Of Pregabalin (Lyrica) With Patients With Generalized Anxiety Disorder - Tabular View

Tracking Information

First Received Date ^ICMJE

February 15, 2008

Last Updated Date

November 19, 2009

Start Date ^ICMJE

April 2009

Estimated Primary Completion Date

May 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Safety endpoints: Adverse events at 3 and 6 months, Physicians Withdrawal Checklist (PWC), Rebound Anxiety (HAM-A), Discontinuation Emergent Signs and Symptoms (DESS) [ Time Frame: 3 and 6 months ] [ Designated as safety issue: Yes ]
Efficacy endpoints: Hamilton Anxiety Scale (HAM-A), Clinical Global Impression-Severity (CGI-S), Clinical Global Impression-Improvement (CGI-I). [ Time Frame: 3 and 6 months ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00624780 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Adverse events [ Time Frame: through study ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Safety and Efficacy Evaluation Of Pregabalin (Lyrica) With Patients With Generalized Anxiety Disorder

Official Title ^ICMJE

Long Term Safety And Efficacy Study Of Pregabalin (Lyrica) In Subjects With Generalized Anxiety Disorder

Brief Summary

The purpose of this study is to characterize the safety and efficacy in patients with generalized anxiety disorder after short- (3 months) and long-term (6 months) use of Pregabalin (Lyrica).

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Generalized Anxiety Disorder

Intervention ^ICMJE

Drug: Pregabalin
Drug: Lorazepam
Drug: Placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

600

Estimated Completion Date

June 2011

Estimated Primary Completion Date

May 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Diagnosis of GAD. HAM-A score >=18 and HAM-D (item 1) score >=2 at screening and baseline. Needs pharmacological treatment.

Exclusion Criteria:

Current or past diagnosis of any other DSM IV Axis I disorders. A history of failed treatment with a benzodiazepine. Any clinically significant, serious, or unstable hematologic, autoimmune, endocrine, cardiovascular, renal, hepatic, gastrointestinal, or neurological disorder.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Location Countries ^ICMJE

Argentina, Austria, Czech Republic, Finland, Greece, India, Indonesia, Lithuania, Russian Federation, Serbia, Slovenia, Spain, Turkey

Administrative Information

NCT ID ^ICMJE

NCT00624780

Responsible Party

Director, Clinical Trials Disclosure Group, Pfizer, Inc.

Study ID Numbers ^ICMJE

A0081147

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP