Naproxen Sodium Extended-Release Actual Use Study
The purpose of this Study is to assess how subjects will use the investigational product in an uncontrolled, naturalistic environment.
Issues on adverse event data are addressed in the Adverse Event section.
The following acronyms and abbreviations were used in the results section.
- General Educational Development (GED)
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
Naproxen Sodium ER (BAYH6689)
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00751400
- ClinicalTrials.gov processed this data on June 18, 2013
Medical and Biotech [MESH] Definitions
An anti-inflammatory agent with analgesic and antipyretic properties. Both the acid and its sodium salt are used in the treatment of rheumatoid arthritis and other rheumatic or musculoskeletal disorders, dysmenorrhea, and acute gout.
Sodium or sodium compounds used in foods or as a food. The most frequently used compounds are sodium chloride or sodium glutamate.
A type of pain that is perceived in an area away from the site where the pain arises, such as facial pain caused by lesion of the VAGUS NERVE, or throat problem generating referred pain in the ear.
A non-steroidal anti-inflammatory agent that is less effective than equal doses of ASPIRIN in relieving pain and reducing fever. However, individuals who are hypersensitive to ASPIRIN may tolerate sodium salicylate. In general, this salicylate produces the same adverse reactions as ASPIRIN, but there is less occult gastrointestinal bleeding. (From AMA Drug Evaluations Annual, 1992, p120)
Stable sodium atoms that have the same atomic number as the element sodium, but differ in atomic weight. Na-23 is a stable sodium isotope.
To determine the pharmacokinetic profile of the investigational product following dosing under fed conditions.
To evaluate the analgesic efficacy of a single, oral dose of a naproxen sodium extended-release tablet, compared to placebo in postsurgical dental pain.
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