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

09:38 EDT 24th April 2014 | 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

Medical and Biotech [MESH] Definitions

A nonsteroidal anti-inflammatory agent with analgesic properties used in the therapy of rheumatism and arthritis.

An IBUPROFEN-type anti-inflammatory analgesic and antipyretic. It is used in the treatment of rheumatoid arthritis and osteoarthritis.

An IBUPROFEN-type anti-inflammatory analgesic and antipyretic. It inhibits prostaglandin synthesis and has been proposed as an anti-arthritic.

A type of oropharyngeal airway that provides an alternative to endotracheal intubation and standard mask anesthesia in certain patients. It is introduced into the hypopharynx to form a seal around the larynx thus permitting spontaneous or positive pressure ventilation without penetration of the larynx or esophagus. It is used in place of a facemask in routine anesthesia. The advantages over standard mask anesthesia are better airway control, minimal anesthetic gas leakage, a secure airway during patient transport to the recovery area, and minimal postoperative problems.

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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