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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00245609
Recruitment Status : Completed
First Posted : October 28, 2005
Last Update Posted : January 22, 2021
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

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.

Condition or disease Intervention/treatment Phase
Dental Anxiety Drug: Pregabalin Drug: Alprazolam Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : January 2006
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Change from baseline to endpoint on the Visual Analogue Scale for Anxiety.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00245609

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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, Germany
United Kingdom
Pfizer Investigational Site
Manchester, Greater Manchester, United Kingdom
Pfizer Investigational Site
Leeds, West Yorkshire, United Kingdom
Pfizer Investigational Site
Sheffield, United Kingdom
Sponsors and Collaborators
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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Study Director: Pfizer Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. Identifier: NCT00245609    
Other Study ID Numbers: A0081072
First Posted: October 28, 2005    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: March 2008
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Hypnotics and Sedatives
GABA Modulators
GABA Agents
Neurotransmitter Agents