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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   Information provided by Pfizer
First Received: October 26, 2005   Last Updated: March 19, 2008   History of Changes

October 26, 2005
March 19, 2008
January 2006
 
Change from baseline to endpoint on the Visual Analogue Scale for Anxiety.
Same as current
Complete list of historical versions of study NCT00245609 on ClinicalTrials.gov Archive Site
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.
Same as current
 
Trial of Pregabalin, Alprazolam, and Placebo in Subjects With Anxiety Prior to Dental Procedure
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

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.

 
Phase II
Interventional
Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Dental Anxiety
  • Drug: Pregabalin
  • Drug: Alprazolam
  • Drug: Placebo
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
90
October 2006
 

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany,   United Kingdom
 
NCT00245609
 
A0081072
Pfizer
 
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP