Status:
COMPLETED
Trial of Pregabalin, Alprazolam, and Placebo in Subjects With Anxiety Prior to Dental Procedure
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Dental Anxiety
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 schedule...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
End Date :
October 1 2006
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00245609
Start Date
January 1 2006
End Date
October 1 2006
Last Update
January 22 2021
Active Locations (9)
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1
Pfizer Investigational Site
Berlin, Germany
2
Pfizer Investigational Site
Cologne, Germany
3
Pfizer Investigational Site
Göttingen, Germany
4
Pfizer Investigational Site
Heidelberg, Germany