Trial of Pregabalin, Alprazolam, and Placebo in Subjects With Anxiety Prior to Dental Procedure - Full Text View

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 related topics:

Anxiety Dental Health

ChemIDplus related topics:

Pregabalin Alprazolam

U.S. FDA Resources

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 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

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

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

Study placed in the following topic categories:

Alprazolam

Pregabalin

Additional relevant MeSH terms:

Neurotransmitter Agents

Tranquilizing Agents

Molecular Mechanisms of Pharmacological Action

GABA Modulators

Physiological Effects of Drugs

Psychotropic Drugs

Central Nervous System Depressants

Pharmacologic Actions

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 September 05, 2008

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00245609