Benzocaine Gel Toothache Dose-Response Study

NCT00474175 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 577

Last updated 2013-02-28

Study results available
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Summary

To evaluate the efficacy and safety of benzocaine gel products for the relief of toothache and to assess the subject's compliance with proposed label directions.

Conditions

  • Toothache

Interventions

DRUG

Placebo gel

single dose (less than 1g) of a matching placebo gel

DRUG

benzocaine

single dose (less than 1g) of 10% benzocaine gel formulation

DRUG

benzocaine

single dose (less than 1g) of 20% benzocaine gel formulation

Sponsors & Collaborators

  • Church & Dwight Company, Inc.

    collaborator INDUSTRY
  • Consumer Healthcare Products Association

    collaborator OTHER
  • Wyeth is now a wholly owned subsidiary of Pfizer

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00474175 on ClinicalTrials.gov