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Study Evaluating a Novel Ibuprofen Formulation in the Treatment of Dental Pain

2014-08-27 03:14:46 | BioPortfolio

Summary

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

Description

This is a single-center, single-dose study to evaluate the efficacy of a novel ibuprofen formulation compared to placebo and two formulations of standard ibuprofen in the treatment of post-surgical dental pain. Patients will be randomized to receive either a single dose of a novel ibuprofen formulation (equal to 400mg ibuprofen), placebo, or one of two formulations of standard ibuprofen (400mg). After taking the study drug, patients will record the onset of first perceptible relief and meaningful relief using two stopwatches. Additionally, patients will measure their pain intensity and pain relief using standard pain scales at pre-specified time points over an eight hour period.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Pain

Intervention

Novel Ibuprofen, Standard Ibuprofen, Standard Ibuprofen, Placebo

Location

Salt Lake City
Utah
United States
84124

Status

Recruiting

Source

Wyeth

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:46-0400

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Pain is defined by the International Association for the Study of Pain as “an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage”. Some illnesses can be excruci...


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