NCT00245609

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2006

Shorter than P25 for phase_2

Geographic Reach
2 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 28, 2005

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2006

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

January 22, 2021

Status Verified

March 1, 2008

First QC Date

October 26, 2005

Last Update Submit

January 20, 2021

Conditions

Dental Anxiety

Outcome Measures

Primary Outcomes (1)

  • Change from baseline to endpoint on the Visual Analogue Scale for Anxiety.

Secondary Outcomes (1)

  • 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.

Interventions

PregabalinDRUG
AlprazolamDRUG
PlaceboDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Pfizer Investigational Site

Berlin, Germany

Location

Pfizer Investigational Site

Cologne, Germany

Location

Pfizer Investigational Site

Göttingen, Germany

Location

Pfizer Investigational Site

Heidelberg, Germany

Location

Pfizer Investigational Site

München, Germany

Location

Pfizer Investigational Site

Tübingen, Germany

Location

Pfizer Investigational Site

Manchester, Greater Manchester, United Kingdom

Location

Pfizer Investigational Site

Leeds, West Yorkshire, United Kingdom

Location

Pfizer Investigational Site

Sheffield, United Kingdom

Location

Related Links

MeSH Terms

Interventions

PregabalinAlprazolam

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and ProteinsBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2005

First Posted

October 28, 2005

Study Start

January 1, 2006

Study Completion

October 1, 2006

Last Updated

January 22, 2021

Record last verified: 2008-03

Locations

DE(6)GB(3)