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, nap...

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 musculoskelet...

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
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A Study To Investigate Whether PF-04457845 Is Effective In Treating Pain, Is Safe And Tolerable In Patients With Osteoarthritis Of The Knee

Phase 2
Completed
Conditions
Interventions
First Posted Date
2009-09-22
Last Posted Date
2017-09-19
Lead Sponsor
Pfizer
Target Recruit Count
76
Registration Number
NCT00981357
Locations
🇺🇸

Arthritis & Rheumatic Care Center, Miami, Florida, United States

🇺🇸

CEDRA Clinical Research, LLC, San Antonio, Texas, United States

🇸🇪

Centrum for klinisk provning, Goteborg, Sweden

and more 3 locations

Oral Bioequivalence Study of PL 3100 and Naproxen in Healthy Adults

Phase 1
Completed
Conditions
Interventions
First Posted Date
2009-08-27
Last Posted Date
2015-09-07
Lead Sponsor
PLx Pharma
Target Recruit Count
34
Registration Number
NCT00966641
Locations
🇺🇸

Houston Institute for Clinical Research, Houston, Texas, United States

Double-blind Placebo-controlled 2-part Study Assessing the Safety, Tolerability and PK of AZD1386 in Healthy Volunteers

First Posted Date
2009-07-24
Last Posted Date
2010-12-10
Lead Sponsor
AstraZeneca
Target Recruit Count
11
Registration Number
NCT00945178
Locations
🇬🇧

Research Site, Harrow, United Kingdom

Study of Flavocoxid (Limbrel) Versus Naproxen in Subjects With Moderate-Severe Osteoarthritis of the Knee

First Posted Date
2009-06-26
Last Posted Date
2017-12-13
Lead Sponsor
Primus Pharmaceuticals
Target Recruit Count
350
Registration Number
NCT00928837
Locations
🇺🇸

Alan Kivitz MD, Duncansville, Pennsylvania, United States

Study Evaluating Ibuprofen 600 mg Extended Release (ER) For Dental Pain

Phase 2
Completed
Conditions
Interventions
First Posted Date
2009-06-04
Last Posted Date
2018-03-22
Lead Sponsor
Pfizer
Target Recruit Count
196
Registration Number
NCT00913627
Locations
🇺🇸

Jean Brown Research Center, Salt Lake City, Utah, United States

Effect of Repeated Dosing of Naproxcinod on Renal Hemodynamic and on Sodium Balance in Healthy Volunteers Before and After a Single Dose of Furosemide

First Posted Date
2009-05-28
Last Posted Date
2011-06-17
Lead Sponsor
NicOx
Target Recruit Count
31
Registration Number
NCT00909519

Phase I Study to Evaluate Bioavailability of Naproxen as PN400 Compared to Naproxen as Naprosyn E

Phase 1
Completed
Conditions
Interventions
First Posted Date
2009-05-22
Last Posted Date
2010-12-10
Lead Sponsor
AstraZeneca
Target Recruit Count
48
Registration Number
NCT00907400
Locations
🇸🇪

Research Site, Uppsala, Sweden

A Study of Tanezumab in Adults With Chronic Low Back Pain

First Posted Date
2009-04-06
Last Posted Date
2021-07-07
Lead Sponsor
Pfizer
Target Recruit Count
1359
Registration Number
NCT00876187
Locations
🇺🇸

Comprehensive Clinical Research, Berlin, New Jersey, United States

🇺🇸

Advances In Health, Inc., Houston, Texas, United States

🇺🇸

Clinical Research Consortium, Las Vegas, Nevada, United States

and more 126 locations

Tanezumab in Osteoarthritis of the Hip or Knee (2)

First Posted Date
2009-03-17
Last Posted Date
2021-05-17
Lead Sponsor
Pfizer
Target Recruit Count
849
Registration Number
NCT00863304
Locations
🇺🇸

HeartCare Research, Sarasota, Florida, United States

🇺🇸

Spring Clinical Research, Sugar Land, Texas, United States

🇺🇸

Sugar Land Med-Ped, P.A., Sugar Land, Texas, United States

and more 91 locations

Infliximab for Treatment of Axial Spondyloarthritis (P05336 AM1)

First Posted Date
2009-02-16
Last Posted Date
2017-04-12
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
158
Registration Number
NCT00844805
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