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

This study has been completed.

First Received: October 26, 2005 Last Updated: March 19, 2008 History of Changes

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

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Dental Health

Drug Information available for: Alprazolam Pregabalin

U.S. FDA Resources

Further study details as provided by Pfizer:

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.

Estimated Enrollment:	90
Study Start Date:	January 2006
Study Completion Date:	October 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00245609

Locations

Germany
Pfizer Investigational Site
Heidelberg, Germany
Pfizer Investigational Site
Goettingen, Germany
Pfizer Investigational Site
Tuebingen, Germany
Pfizer Investigational Site
Koeln, Germany
Pfizer Investigational Site
Muenchen, Germany
Pfizer Investigational Site
Berlin, Germany
United Kingdom
Pfizer Investigational Site
Sheffield, United Kingdom
United Kingdom, Greater Manchester
Pfizer Investigational Site
Manchester, Greater Manchester, United Kingdom
United Kingdom, West Yorkshire
Pfizer Investigational Site
Leeds, West Yorkshire, United Kingdom

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org Posting This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	A0081072
Study First Received:	October 26, 2005
Last Updated:	March 19, 2008
ClinicalTrials.gov Identifier:	NCT00245609 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study placed in the following topic categories:

Neurotransmitter Agents
Tranquilizing Agents
Alprazolam
Hypnotics and Sedatives
Psychotropic Drugs
Central Nervous System Depressants

Pregabalin
Anti-Anxiety Agents
Peripheral Nervous System Agents
Analgesics
Anticonvulsants

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
Physiological Effects of Drugs
Psychotropic Drugs
Pregabalin
Central Nervous System Depressants
Pharmacologic Actions
Alprazolam

Sensory System Agents
Therapeutic Uses
Hypnotics and Sedatives
GABA Agents
Anti-Anxiety Agents
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on July 06, 2009