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

Dental Anxiety Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00245609
• Other study ID #: A0081072
• Status: Completed
• Phase: Phase 2
• Start date: January 2006
• Est. completion date: October 2006

Study information

• Verified date: March 2008
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: October 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Dental Anxiety

Intervention

Drug:
• Pregabalin

• Alprazolam

• Placebo

Locations

Country	Name	City	State
Germany	Pfizer Investigational Site	Berlin
Germany	Pfizer Investigational Site	Goettingen
Germany	Pfizer Investigational Site	Heidelberg
Germany	Pfizer Investigational Site	Koeln
Germany	Pfizer Investigational Site	Muenchen
Germany	Pfizer Investigational Site	Tuebingen
United Kingdom	Pfizer Investigational Site	Leeds	West Yorkshire
United Kingdom	Pfizer Investigational Site	Manchester	Greater Manchester
United Kingdom	Pfizer Investigational Site	Sheffield

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Countries where clinical trial is conducted

Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to endpoint on the Visual Analogue Scale for Anxiety.
Secondary	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.

External Links

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