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, 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

Clinical Trials

Is Kinesio Taping Effective to the Radial Nerve in Patients With Lateral Epicondylitis?

Not Applicable

Completed

Conditions: Lateral Epicondylitis

Interventions: Other: Kinesio Tape
Drug: oral naproxen

First Posted Date: 2019-01-04

Last Posted Date: 2019-09-20

Lead Sponsor: Ankara Education and Research Hospital

Target Recruit Count: 80

Registration Number: NCT03794219

Locations: 🇹🇷
Basak Mansiz-Kaplan, Ankara, Turkey

Inflammation and Daily Life Study

Early Phase 1

Completed

Conditions: Inflammation

Interventions: Drug: Naproxen
Drug: Placebos

First Posted Date: 2018-12-11

Last Posted Date: 2025-02-25

Lead Sponsor: University of California, Los Angeles

Target Recruit Count: 144

Registration Number: NCT03771612

Locations: 🇺🇸
UCLA Department of Psychology, Los Angeles, California, United States

NSAIDs vs. Coxibs in the Presence of Aspirin

Phase 4

Recruiting

Conditions: Cardiovascular Diseases
Rheumatoid Arthritis

Interventions: Drug: naproxen sodium 550mg tablet
Drug: celecoxib 200mg capsule
Drug: Aspirin 81mg tablet

First Posted Date: 2018-10-09

Last Posted Date: 2018-10-09

Lead Sponsor: Inova Health Care Services

Target Recruit Count: 30

Registration Number: NCT03699293

Locations: 🇺🇸
Inova Heart and Vascular Institute, Falls Church, Virginia, United States

A Study to Assess Bioquivalence Between a Novel Naproxen Sodium 275 mg Film-coated Tablet and Nalgesin Naproxen Sodium 275 mg Film-coated Tablet in Healthy Adult Volunteers

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Naproxen sodium (test product)
Drug: Naproxen sodium (reference product)

First Posted Date: 2018-10-05

Last Posted Date: 2020-01-23

Lead Sponsor: McNeil AB

Target Recruit Count: 28

Registration Number: NCT03697889

Locations: 🇷🇺
LLC "Scientific and Research centre Eco-safety", St.Petersburg, Russian Federation

Examining the Role of Improved NSAID Management in Treating Dysmenorrhea and Bladder Pain

Phase 4

Completed

Conditions: Dysmenorrhea
Pain

Interventions: Drug: Naproxen

First Posted Date: 2018-10-05

Last Posted Date: 2023-10-18

Lead Sponsor: NorthShore University HealthSystem

Target Recruit Count: 26

Registration Number: NCT03697720

Locations: 🇺🇸
NorthShore University Health System, Evanston, Illinois, United States

A Study to Evaluate the Efficacy and Safety of Gefapixant (MK-7264) in Women With Endometriosis-Related Pain (MK-7264-034)

Phase 2

Completed

Conditions: Endometriosis-related Pain

Interventions: Drug: Placebo
Drug: Gefapixant
Drug: Naproxen

First Posted Date: 2018-08-31

Last Posted Date: 2024-11-04

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 187

Registration Number: NCT03654326

Locations: 🇺🇸
Synexus US Phoenix Southeast ( Site 0729), Chandler, Arizona, United States
🇺🇸
Lynn Institute of the Ozarks ( Site 0720), Little Rock, Arkansas, United States
🇺🇸
Thameside OBGYN Center ( Site 0747), Groton, Connecticut, United States

and more 75 locations