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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

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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
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Link to ClinicalStudyResults.org Posting This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  90
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 No
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.




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