Study Evaluating A Novel Ibuprofen Formulation In The Treatment Of Dental Pain

NCT01216163 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 218

Last updated 2012-08-20

Study results available
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Summary

This study will compare the analgesic efficacy of a single-dose of a novel ibuprofen formulation to placebo and acetaminophen in the treatment of post-surgical dental pain following "wisdom" tooth (third molar) removal.

Conditions

Interventions

DRUG

Novel Ibuprofen

Single-dose of novel ibuprofen (equal to 400 mg ibuprofen)

DRUG

Acetaminophen

Single-dose of acetaminophen (1000mg)

DRUG

Placebo

Single-dose of placebo

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2011-01-31
Completion
2011-01-31

Countries

  • United States

Study Locations

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Entities

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 NCT01216163 on ClinicalTrials.gov