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: C_₁₄H_₁₄O_₃

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: -

Clinical Trials

Assessment of Pharmacokinetics of a Single Oral Dose of VIMOVO in Healthy Adult Volunteers

Phase 1

Completed

Conditions: Juvenile Idiopathic Arthritis

First Posted Date: 2011-05-23

Last Posted Date: 2012-06-22

Lead Sponsor: AstraZeneca

Target Recruit Count: 28

Registration Number: NCT01358383

Locations: 🇺🇸
Research Site, Overland Park, Kansas, United States

A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-39439335 in Patients With Osteoarthritis

Phase 1

Completed

Conditions: Osteoarthritis, Knee

Interventions: Drug: JNJ-39439335
Drug: Naproxen
Drug: Placebo

First Posted Date: 2011-04-28

Last Posted Date: 2012-08-09

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 43

Registration Number: NCT01343303

Treximet Trademark (TM) in the Prevention and Modification of Disease Progression in Migraine

Phase 4

Completed

Conditions: Migraine

Interventions: Drug: Sumatriptan/Naproxen Sodium
Drug: Naproxen Sodium

First Posted Date: 2011-02-21

Last Posted Date: 2013-05-21

Lead Sponsor: Cady, Roger, M.D.

Target Recruit Count: 40

Registration Number: NCT01300546

Locations: 🇺🇸
Newport Beach Clinical Research Assoc., Inc., Newport Beach, California, United States
🇺🇸
Clinvest, Springfield, Missouri, United States

Acute Osteoarthritis Experimental Model Study.

Phase 2

Completed

Conditions: Osteoarthritis

Interventions: Drug: Placebo
Drug: Naproxen

First Posted Date: 2010-11-01

Last Posted Date: 2011-01-31

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 53

Registration Number: NCT01231490

Locations: 🇬🇧
GSK Investigational Site, Manchester, United Kingdom

Study of Naproxen Capsules to Treat Dental Pain

Phase 2

Completed

Conditions: Dental Pain

Interventions: Drug: Naprosyn
Drug: Placebo
Drug: Naproxen Test

First Posted Date: 2010-10-27

Last Posted Date: 2012-05-22

Lead Sponsor: Iroko Pharmaceuticals, LLC

Target Recruit Count: 254

Registration Number: NCT01229228

Locations: 🇺🇸
Premier Research Group Limited, Austin, Texas, United States

A Study of ABT-652 in Adults With Osteoarthritis Pain of the Knee

Phase 2

Completed

Conditions: Osteoarthritis of the Knee

Interventions: Drug: ABT-652
Drug: Naproxen
Drug: Placebo

First Posted Date: 2010-09-22

Last Posted Date: 2013-01-07

Lead Sponsor: AbbVie (prior sponsor, Abbott)

Target Recruit Count: 322

Registration Number: NCT01207115

Locations: 🇺🇸
Site Reference ID/Investigator# 37222, Burbank, California, United States
🇺🇸
Site Reference ID/Investigator# 37227, Milford, Connecticut, United States
🇺🇸
Site Reference ID/Investigator# 37229, Boynton Beach, Florida, United States

and more 35 locations

The Effects of Three Oral Medications on Post-operative Pain Following Endodontic Treatment

Phase 1

Completed

Conditions: Pulpitis
Pain Management

First Posted Date: 2010-08-10

Last Posted Date: 2010-08-10

Lead Sponsor: Azad University of Medical Sciences

Registration Number: NCT01178203

To Determine the Safety, Tolerability, Pharmacokinetics and Effect on Pain of a Single Intra-articular Administration of Canakinumab in Patients With Osteoarthritis in the Knee

Phase 2

Completed

Conditions: Osteoarthritis

Interventions: Drug: Placebo to canakinumab
Biological: Canakinumab
Drug: Placebo to Naproxen
Drug: Naproxen

First Posted Date: 2010-07-12

Last Posted Date: 2012-10-30

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 169

Registration Number: NCT01160822

Locations: 🇺🇸
Pinnacle Research Group, LLC, Anniston, Alabama, United States
🇺🇸
Westlake Medical Research, Westlake Village, California, United States
🇺🇸
San Diego Arthritis & Osteoporosis Medical Clinic, San Diego, California, United States

and more 6 locations