Trial of Pregabalin, Alprazolam, and Placebo in Subjects With Anxiety Prior to Dental Procedure
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00245609
Collaborator
(none)
90
9
9
10
1.1
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
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
:
Jan 1, 2006
Actual Study Completion Date
:
Oct 1, 2006
Outcome Measures
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. []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer Investigational Site | Berlin | Germany | ||
| 2 | Pfizer Investigational Site | Goettingen | Germany | ||
| 3 | Pfizer Investigational Site | Heidelberg | Germany | ||
| 4 | Pfizer Investigational Site | Koeln | Germany | ||
| 5 | Pfizer Investigational Site | Muenchen | Germany | ||
| 6 | Pfizer Investigational Site | Tuebingen | Germany | ||
| 7 | Pfizer Investigational Site | Manchester | Greater Manchester | United Kingdom | |
| 8 | Pfizer Investigational Site | Leeds | West Yorkshire | United Kingdom | |
| 9 | Pfizer Investigational Site | Sheffield | United Kingdom |
Sponsors and Collaborators
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier:
NCT00245609
Other Study ID Numbers:
- A0081072
First Posted:
Oct 28, 2005
Last Update Posted:
Jan 22, 2021
Last Verified:
Mar 1, 2008