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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
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Novel Ibuprofen, Standard Ibuprofen, Standard Ibuprofen, Placebo
Salt Lake City
Published on BioPortfolio: 2014-08-27T03:14:46-0400
This is a study of healthy volunteers to compare how quickly different ibuprofen products relieve dental pain.
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Certification as complying with a standard set by non-governmental organizations, applied for by institutions, programs, and facilities on a voluntary basis.
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