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
GermanyPfizer 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 KingdomPfizer Investigational Site, Sheffield,
S10 2TN,
United Kingdom; Completed
United Kingdom, Greater ManchesterPfizer Investigational Site, Manchester,
Greater Manchester,
M15 6FH,
United Kingdom; Recruiting
United Kingdom, West YorkshirePfizer 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:
NCT00245609Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency ClinicalTrials.gov processed this record on 2006-10-18 |
