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

Associated Therapies: -

Clinical Trials

Intensive Urate Lowering Therapy of Febuxostat Compared to Allopurinol on Cardiovascular Risk in Patients With Gout

Phase 4

Completed

Conditions: Gout

Interventions: Drug: Febuxostat 80/120mg/day
Drug: Allopurinol 100 up to 600mg/day
Drug: Colchicine
Drug: Naproxen
Drug: Omeprazole

First Posted Date: 2015-07-16

Last Posted Date: 2019-06-21

Lead Sponsor: Menarini International Operations Luxembourg SA

Target Recruit Count: 196

Registration Number: NCT02500641

Locations: 🇵🇱
Specjalistyczna Praktyka Lekarska Piotr Kubalski, Grudziądz, Poland
🇵🇱
Oddział Kardiologiczny, WSS im. W. Biegańskiego w Łodzi, Łódź, Poland
🇷🇴
S.C. Cardiomed S.R.L., Craiova, Romania

and more 23 locations

Naproxen on Tooth Sensitivity Caused by In-office Bleaching

Not Applicable

Completed

Conditions: Toothache
Tooth Bleaching

Interventions: Drug: Naproxen

First Posted Date: 2015-06-04

Last Posted Date: 2016-10-26

Lead Sponsor: Universidade Federal de Sergipe

Target Recruit Count: 50

Registration Number: NCT02463552

Locations: 🇧🇷
Universidade Federal de Sergipe, Aracaju, SE, Brazil

IL-7 and IL-7R Expression in RA Patients With Active vs. Inactive Disease Treated With DMARD or CIMZIA

Phase 4

Completed

Conditions: Rheumatoid Arthritis

Interventions: Other: Lab Work
Drug: Certolizumab pegol (CDP870, tradename Cimzia)(prefilled syringes at the dose of 200mg)
Drug: Certolizumab pegol (CDP870, tradename Cimzia)
Drug: Hydroxychloroquine
Drug: Sulfasalazine
Drug: Medrol
Drug: Prednisone
Drug: Triamcinolone
Drug: Naproxen
Drug: Leflunomide
Drug: Methotrexate
Drug: humira

First Posted Date: 2015-05-22

Last Posted Date: 2024-07-10

Lead Sponsor: University of Illinois at Chicago

Target Recruit Count: 32

Registration Number: NCT02451748

Locations: 🇺🇸
Outpatient Care Center, Chicago, Illinois, United States

Pilot Study of OXP005 to Assess Gastroduodenal Irritation

Phase 1

Completed

Conditions: Gastroduodenal Erosions

Interventions: Drug: OXP005
Drug: Naproxen

First Posted Date: 2015-04-06

Last Posted Date: 2015-06-18

Lead Sponsor: Oxford Pharmascience Ltd

Registration Number: NCT02408978

Locations: 🇬🇧
Quotient Clinical Ltd, Nottingham, United Kingdom

Naproxen for Pain Control With Intrauterine Device Insertion

Not Applicable

Completed

Conditions: Contraception

Interventions: Drug: Naproxen sodium
Other: Placebo tablet

First Posted Date: 2015-03-13

Last Posted Date: 2017-06-22

Lead Sponsor: Planned Parenthood League of Massachusetts

Target Recruit Count: 119

Registration Number: NCT02388191

Locations: 🇺🇸
Planned Parenthood League of Massachusetts, Boston, Massachusetts, United States

NSAIDs for Pain After Ankle Fracture Surgery

Phase 4

Withdrawn

Conditions: Closed Fracture of Ankle

Interventions: Drug: Placebo
Drug: Naproxen

First Posted Date: 2014-11-04

Last Posted Date: 2015-12-18

Lead Sponsor: Northwell Health

Registration Number: NCT02281968

PF-06372865 In Subjects With Chronic Low Back Pain

Phase 2

Completed

Conditions: Chronic Low Back Pain

Interventions: Drug: PF-06372865
Drug: Placebo
Drug: Naproxen

First Posted Date: 2014-10-13

Last Posted Date: 2017-01-04

Lead Sponsor: Pfizer

Target Recruit Count: 302

Registration Number: NCT02262754

Locations: 🇺🇸
S&W Clinical Research, Fort Lauderdale, Florida, United States
🇺🇸
Neuro-Pain Medical Center, Fresno, California, United States
🇺🇸
Pines Clinical Research Inc., Pembroke Pines, Florida, United States

and more 42 locations