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

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

This study has been completed.

Study NCT00245609. Last updated on March 19, 2008. Information provided by Pfizer

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

Official Title ^†

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 ^†

Interventional

Study Design ^†

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

Primary Outcome Measure ^†

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

Secondary Outcome Measure ^†

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.

Condition ^†

Dental Anxiety

Intervention ^†

Drug: Pregabalin
Drug: Alprazolam
Drug: Placebo

MEDLINE PMIDs

Links

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org Posting This link exits the ClinicalTrials.gov site

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

Start Date ^†

January 2006

Completion Date

October 2006

Eligibility Criteria ^†

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 ^††

Location Countries ^†

Germany, United Kingdom

Administrative Information Fields

NCT ID ^†

NCT00245609

Organization ID

A0081072

Secondary IDs ^††

Study Sponsor ^†

Pfizer

Collaborators ^††

Investigators ^†

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

March 2008

First Received Date ^†

October 26, 2005

Last Updated Date

March 19, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.