Naproxen

Generic Name
Naproxen
Brand Names
Aleve, Aleve PM, Aleve-D, Anaprox, Naprelan, Naprosyn, Sallus, Sudafed Sinus & Pain, Treximet, Vimovo
Drug Type
Small Molecule
Chemical Formula
C14H14O3
CAS Number
22204-53-1
Unique Ingredient Identifier
57Y76R9ATQ
Background

Naproxen is classified as a nonsteroidal anti-inflammatory dug (NSAID) and was initially approved for prescription use in 1976 and then for over-the-counter (OTC) use in 1994. It can effectively manage acute pain as well as pain related to rheumatic diseases, and has a well studied adverse effect profile. Given its overall tolerability and effectiveness, naproxen can be considered a first line treatment for a variety of clinical situations requiring analgesia. Naproxen is available in both immediate and delayed release formulations, in combination with sumatriptan to treat migraines, and in combination with esomeprazole to lower the risk of developing gastric ulcers.

Indication

Naproxen is indicated for the management of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, polyarticular juvenile idiopathic arthritis, tendinitis, bursitis, acute gout, primary dysmenorrhea, and for the relief of mild to moderate pain. Further, it is first-line therapy for osteoarthritis, acute gouty arthritis, dysmenorrhea, and musculoskeletal inflammation and pain.

Associated Conditions
Acute Gouty Arthritis, Acute Migraine, Ankylosing Spondylitis (AS), Back pain, Bursitis, Extra-Articular Rheumatism, Fever, Flu caused by Influenza, Headache, Juvenile Idiopathic Arthritis (JIA), Menstrual Distress (Dysmenorrhea), Migraine, Muscle Spasms, Nasal Congestion, Osteoarthritis (OA), Pain, Post Traumatic Pain, Postoperative pain, Primary Dysmenorrhoea, Rheumatoid Arthritis, Rheumatoid Arthritis, Juvenile, Seasonal Allergic Rhinitis, Sinusitis, Tendinitis, Toothache, Articular inflammation
Associated Therapies
-

Clinical Trial Evaluating Gastrointestinal Damage Following Administration PL3100 or Naproxen in At-Risk Adults

First Posted Date
2010-06-08
Last Posted Date
2016-04-11
Lead Sponsor
PLx Pharma
Target Recruit Count
77
Registration Number
NCT01139190
Locations
🇺🇸

Dallas VA Medical Center, Dallas, Texas, United States

🇺🇸

Houston Center For Clinical Research, Houston, Texas, United States

Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers Compared to Non-steroidal Antiinflammatory Drug (NSAID) Naproxen

Phase 3
Completed
Conditions
Interventions
First Posted Date
2010-05-24
Last Posted Date
2010-12-28
Lead Sponsor
POZEN
Target Recruit Count
420
Registration Number
NCT01129011

Study to Evaluate Efficacy and Safety of IW-6118 in Patients Undergoing Third Molar Extraction

First Posted Date
2010-04-20
Last Posted Date
2022-08-11
Lead Sponsor
Ironwood Pharmaceuticals, Inc.
Target Recruit Count
90
Registration Number
NCT01107236
Locations
🇺🇸

Ironwood Investigational Site, Salt Lake City, Utah, United States

Clinical Trial to Examine the Pain Relief of PH-797804 Alone Or With Naproxen in Subjects With Osteoarthritis of the Knee

First Posted Date
2010-04-13
Last Posted Date
2014-08-22
Lead Sponsor
Pfizer
Target Recruit Count
172
Registration Number
NCT01102660
Locations
🇺🇸

Pfizer Investigational Site, San Antonio, Texas, United States

Changes in mRNA Expression Following Exposure to Naproxen

Not Applicable
Completed
Conditions
Interventions
First Posted Date
2010-03-22
Last Posted Date
2010-03-22
Lead Sponsor
Research Associates of New York, LLP
Target Recruit Count
48
Registration Number
NCT01090596

Treximet in the Treatment of Chronic Migraine

First Posted Date
2010-03-19
Last Posted Date
2013-07-03
Lead Sponsor
Cady, Roger, M.D.
Target Recruit Count
56
Registration Number
NCT01090050
Locations
🇺🇸

Clinvest, Springfield, Missouri, United States

🇺🇸

Texas Headache Associates, San Antonio, Texas, United States

Trial of Comprehensive Migraine Intervention

First Posted Date
2010-02-19
Last Posted Date
2018-08-31
Lead Sponsor
Montefiore Medical Center
Target Recruit Count
50
Registration Number
NCT01071317
Locations
🇺🇸

Montefiore Medical Center, Bronx, New York, United States

Bioequivalence Study of Naproxen Sodium 550 mg Tablets Under Fasting Condition

Phase 1
Completed
Conditions
Interventions
First Posted Date
2010-01-20
Last Posted Date
2010-05-27
Lead Sponsor
Dr. Reddy's Laboratories Limited
Target Recruit Count
26
Registration Number
NCT01052129
Locations
🇮🇳

Wellquest Clinical Research, Mumbai, Maharashtra, India

Bioequivalence Study of Naproxen Sodium 550 mg Tablets Under Fed Conditions

Phase 1
Completed
Conditions
Interventions
First Posted Date
2010-01-20
Last Posted Date
2010-01-20
Lead Sponsor
Dr. Reddy's Laboratories Limited
Target Recruit Count
26
Registration Number
NCT01052792
Locations
🇮🇳

Wellquest Clinical Research, Mumbai, Maharashtra, India

Comparison Study of a New Combination of 2 Marketed Medications (Esomeprazole and Naprosyn) Versus Naprosyn Alone

Phase 1
Completed
Conditions
Interventions
First Posted Date
2009-10-09
Last Posted Date
2010-01-18
Lead Sponsor
AstraZeneca
Target Recruit Count
24
Registration Number
NCT00992381
Locations
🇦🇺

Research Site, Brisbane, Queensland, Australia

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