Back to resultsTrial of Pregabalin, Alprazolam, and Placebo in Subjects With Anxiety Prior to Dental Procedure
Primary Purpose
Dental Anxiety
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Pregabalin
Alprazolam
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Dental Anxiety
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.
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Outcomes
Primary Outcome Measures
Change from baseline to endpoint on the Visual Analogue Scale for Anxiety.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT00245609
First Posted
October 26, 2005
Last Updated
January 20, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00245609
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
90 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Pregabalin
Intervention Type
Drug
Intervention Name(s)
Alprazolam
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change from baseline to endpoint on the Visual Analogue Scale for Anxiety.
Secondary Outcome Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Berlin
Country
Germany
Facility Name
Pfizer Investigational Site
City
Goettingen
Country
Germany
Facility Name
Pfizer Investigational Site
City
Heidelberg
Country
Germany
Facility Name
Pfizer Investigational Site
City
Koeln
Country
Germany
Facility Name
Pfizer Investigational Site
City
Muenchen
Country
Germany
Facility Name
Pfizer Investigational Site
City
Tuebingen
Country
Germany
Facility Name
Pfizer Investigational Site
City
Manchester
State/Province
Greater Manchester
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Leeds
State/Province
West Yorkshire
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Sheffield
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0081072&StudyName=Trial+of+pregabalin%2C+alprazolam%2C+and+placebo+in+subjects+with+anxiety+prior+to+dental+procedure
Description
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Learn more about this trial
Trial of Pregabalin, Alprazolam, and Placebo in Subjects With Anxiety Prior to Dental Procedure
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