Trial of Pregabalin, Alprazolam, and Placebo in Subjects With Anxiety Prior to Dental Procedure - Tabular View

Tracking Information

First Received Date ^ICMJE

October 26, 2005

Last Updated Date

March 19, 2008

Start Date ^ICMJE

January 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Change from baseline to endpoint on the Visual Analogue Scale for Anxiety.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00245609 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

The changes from baseline to endpoint, and changes from baseline to each rating timepoint differ among the three treatment groups for the VAS-Anxiety, VAS-Sedation, Time to Onset of Activity Scales scores, and, Dental Anxiety scales.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Trial of Pregabalin, Alprazolam, and Placebo in Subjects With Anxiety Prior to Dental Procedure

Official Title ^ICMJE

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial Of The Anxiolytic Efficacy Of Pregabalin And Alprazolam IR In Subjects With Anxiety Prior To Dental Procedure

Brief Summary

The primary purpose of the trial is to assess how effective pregabalin, alprazolam, and placebo are at reducing anxiety levels of subjects who take a dose of these treatments 4 hours before a scheduled dental procedure.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Dental Anxiety

Intervention ^ICMJE

Drug: Pregabalin
Drug: Alprazolam
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

Completed

Enrollment ^ICMJE

Completion Date

October 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Male or female outpatients 18 years of age or older who score 12 points or more on the Dental Anxiety Scale at screening and baseline evaluations and have a scheduled appointment for an elective dental procedure.

Exclusion Criteria:

Current diagnosis of any of the DSM-IV anxiety disorders.
Current diagnosis of major depressive disorder, dysthymia, schizophrenia or any other psychotic disorder, bipolar disorder, and eating disorders as assessed by the M.I.N.I. at screening, or current diagnosis of delirium, dementia, or body dysmorphic disorder.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00245609

Responsible Party

Study ID Numbers ^ICMJE

A0081072

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

March 2008

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