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

This study is currently recruiting patients

Verified by Pfizer October 2006

Sponsored by: Pfizer
Information provided by: Pfizer
ClinicalTrials.gov Identifier: NCT00245609


Purpose

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.


Condition Intervention Phase
Dental Anxiety Drug: Pregabalin
Drug: Alprazolam
Drug: Placebo
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by Pfizer:
Primary Outcomes: Change from baseline to endpoint on the Visual Analogue Scale for Anxiety.
Secondary Outcomes: 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.
Expected Total Enrollment:  90

Study start: January 2006

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  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.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00245609

Pfizer CT.gov Call Center      1-800-718-1021 

Germany
Pfizer Investigational Site, Heidelberg,  69115,  Germany; Recruiting

Pfizer Investigational Site, Goettingen,  37075,  Germany; Completed

Pfizer Investigational Site, Tuebingen,  72076,  Germany; Completed

Pfizer Investigational Site, Koeln,  50931,  Germany; Recruiting

Pfizer Investigational Site, Muenchen,  80336,  Germany; Completed

Pfizer Investigational Site, Berlin,  10117,  Germany; Recruiting

United Kingdom
Pfizer Investigational Site, Sheffield,  S10 2TN,  United Kingdom; Completed

United Kingdom, Greater Manchester
Pfizer Investigational Site, Manchester,  Greater Manchester,  M15 6FH,  United Kingdom; Recruiting

United Kingdom, West Yorkshire
Pfizer Investigational Site, Leeds,  West Yorkshire,  LS2 9LU,  United Kingdom; Completed

Study chairs or principal investigators

Pfizer CT.gov Call Center,  Study Director,  Pfizer   

More Information

Study ID Numbers:  A0081072
Last Updated:  October 11, 2006
Record first received:  October 26, 2005
ClinicalTrials.gov Identifier:  NCT00245609
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
ClinicalTrials.gov processed this record on 2006-10-18





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