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Pregabalin

Phase 2

Dental Anxiety | Small molecule | Psychiatry |Viatris Inc.|Last Updated: Jan 22, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment90

FDA Designations

No designations recorded

Clinical trial landscape

Pregabalin · 1 trial · 1 indication

Phase 2 1
NCT00245609Trial of Pregabalin, Alprazolam, and Placebo in Subjects With Anxiety Prior to Dental ProcedureDental Anxiety
COMPLETED90 Analytics
PHASE2COMPLETED
Trial of Pregabalin, Alprazolam, and Placebo in Subjects With Anxiety Prior to Dental Procedure
Dental Anxiety
NCT0024560990
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Study Endpoints

Primary Endpoints

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

Secondary Endpoints

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.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
PregabalinDRUG -
AlprazolamDRUG -
PlaceboDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites9

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 a...

Countries:GermanyUnited Kingdom
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