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

Condition(s) targeted: Dental Anxiety

Intervention: Pregabalin (Drug); Alprazolam (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

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

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

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

Secondary outcome: 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Pfizer Investigational Site, Heidelberg, Germany

Pfizer Investigational Site, Goettingen, Germany

Pfizer Investigational Site, Tuebingen, Germany

Pfizer Investigational Site, Koeln, Germany

Pfizer Investigational Site, Muenchen, Germany

Pfizer Investigational Site, Berlin, Germany

Pfizer Investigational Site, Sheffield, United Kingdom

Pfizer Investigational Site, Manchester, Greater Manchester, United Kingdom

Pfizer Investigational Site, Leeds, West Yorkshire, United Kingdom

To obtain contact information for a study center near you, click here.

Link to ClinicalStudyResults.org Posting

Starting date: January 2006
Ending date: October 2006
Last updated: March 19, 2008