Ketoprofen 10% Cream for Treatment of Pain Associated With Mild to Moderate Acute Soft Tissue Injury
Summary
Imprimis Pharmaceuticals is investigating a proprietary, topical cream formulation consisting of 10% ketoprofen (containing 100 mg of ketoprofen in 1gram of cream) for the local treatment of acute musculoskeletal pain.
Description
The primary objective of this study is to determine the efficacy and safety of ketoprofen 10% cream compared to placebo as a three-times-per-day topical application in improving the patient assessment of pain when used to treat mild to moderate acute soft tissue injury of the upper and lower extremities over a 7-day 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
Sprain
Intervention
Topical Ketoprofen 10% Cream, Topical Placebo Cream
Location
CATO Research
Durham
North Carolina
United States
27713
Status
Completed
Source
Imprimis Pharmaceuticals, Inc.
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00765700
- Information obtained from ClinicalTrials.gov on May 16, 2013
Medical and Biotech [MESH] Definitions
Ice Cream
A frozen dairy food made from cream or butterfat, milk, sugar, and flavorings. Frozen custard and French-type ice creams also contain eggs.
Vaginal Creams, Foams, And Jellies
Medicated dosage forms for topical application in the vagina. A cream is a semisolid emulsion containing suspended or dissolved medication; a foam is a dispersion of a gas in a medicated liquid resulting in a light, frothy mass; a jelly is a colloidal semisolid mass of a water soluble medicated material, usually translucent.
Fluorides, Topical
Fluorides, usually in pastes or gels, used for topical application to reduce the incidence of DENTAL CARIES.
Soaps
Sodium or potassium salts of long chain fatty acids. These detergent substances are obtained by boiling natural oils or fats with caustic alkali. Sodium soaps are harder and are used as topical anti-infectives and vehicles in pills and liniments; potassium soaps are soft, used as vehicles for ointments and also as topical antimicrobials.
Dienestrol
A synthetic, non-steroidal estrogen structurally related to stilbestrol. It is used, usually as the cream, in the treatment of menopausal and postmenopausal symptoms.
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The purpose of this study is to evaluate the effect of a ketoprofen topical patch on the pain associated with ankle sprain or strain.
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