Naproxen Sodium Extended-Release Actual Use Study
Summary
The purpose of this Study is to assess how subjects will use the investigational product in an uncontrolled, naturalistic environment.
Description
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)
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
Conditions
Pain
Intervention
Naproxen Sodium ER (BAYH6689)
Location
Anaheim
California
United States
92801
Status
Completed
Source
Bayer
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00751400
- ClinicalTrials.gov processed this data on June 18, 2013
Medical and Biotech [MESH] Definitions
Naproxen
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, Dietary
Sodium or sodium compounds used in foods or as a food. The most frequently used compounds are sodium chloride or sodium glutamate.
Pain, Referred
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.
Sodium Salicylate
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)
Sodium Isotopes
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.
Clinical Trials
Naproxen Sodium ER Pharmacokinetic Study
To determine the pharmacokinetic profile of the investigational product following dosing under fed conditions.
Assessing the Analgesic Efficacy of Naproxen Sodium in Postsurgical Dental Pain.
To evaluate the analgesic efficacy of a single, oral dose of a naproxen sodium extended-release tablet, compared to placebo in postsurgical dental pain.
We are interested in whether bunionectomy can be used as a model to study the treatment of acute pain. It has been used to study the effect of Non-Steroidal Anti-inflammatory (NSAIDS) medi...
The purpose of this study is to assess the bioequivalence of Naproxen sodium 220 mg + Pseudoephedrine Hydrochloride 120 mg Extended Release tablets of with Aleve Cold and Sinus in healthy...
Fast & Fed Pharmacokinetic (PK) Study
The purpose of this study is to provide information on how well an extended release formulation (a medication that is released and absorbed over a longer period of time than a regular rele...
PubMed Articles
AIM: To evaluate the efficacy of transcutaneous electrical nerve stimulation (TENS) for decreasing pain related with office endometrial biopsy....
Evaluation of the use of sumatriptan-naproxen sodium for menstrual migraine and dysmenorrhea.
Evaluation of: Cady RK, Diamond ML, Diamond MP et al. Sumatriptan-naproxen sodium for menstrual migraine and dysmenorrhea: satisfaction, productivity, and functional disability outcomes. Headache 51(5...
Reduced Ulcerogenic Potential and Antiarthritic Effect of Chitosan-Naproxen Sodium Complexes.
The purpose of this research was to address the utility of naproxen sodium-chitosan spray-dried complexes for antiulcer and antiarthritic activities. The cold stress technique was used to examine the...
PURPOSE: To understand the transformation pathways amongst anhydrate/hydrate solid forms of sodium naproxen and to highlight the importance of a polymorphic dihydrate within this context. METHODS: Mul...
To study the safety and efficacy of a new medical food (Theramine) in the treatment of low back pain, we performed a 28-day double-blind randomized controlled trial in 129 patients. Back pain was pres...
