Not Signed In -
Child Dental Health |
Dental Health, Child |
Clinical Trial: Trial of Pregabalin, Alprazolam, and Placebo in Subjects With Anxiety Prior to Dental Procedure
This study is not yet open for patient recruitment.
Verified by Pfizer October 2005
|
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 |
MedlinePlus consumer health information
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
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: October 2005
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
Study chairs or principal investigators
Pfizer CT.gov Call Center, Study Director, Pfizer
More Information
Study ID Numbers: A0081072
Last Updated: December 8, 2005
Record first received: October 26, 2005
ClinicalTrials.gov Identifier: NCT00245609
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-01-10
Last Updated: December 8, 2005
Record first received: October 26, 2005
ClinicalTrials.gov Identifier: NCT00245609
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-01-10
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