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

Safety, Efficacy and Acceptability of Flavocoxid (Limbrel)A Pilot Study

Not Applicable

Completed

Conditions: Osteoarthritis

Interventions: Dietary Supplement: flavocoxid
Drug: Naproxen

First Posted Date: 2006-03-15

Last Posted Date: 2015-10-21

Lead Sponsor: Primus Pharmaceuticals

Target Recruit Count: 60

Registration Number: NCT00303017

Locations: 🇺🇸
Timothy Truitt MD, Melbourne, Florida, United States

A One Year Double-blind Trial to Investigate the Efficacy and Safety of Meloxicam Oral Suspension in Juvenile Rheumatoid Arthritis (JRA/JIA)

Phase 3

Completed

Conditions: Arthritis, Juvenile Rheumatoid

First Posted Date: 2006-01-20

Last Posted Date: 2013-11-01

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 226

Registration Number: NCT00279747

Locations: 🇦🇹
Univ.-Klinik für Kinder- und Jugendheilkunde Wien, Wien, Austria
🇦🇹
Gottfried Preyersches Kinderspital d. Stadt Wien, Wien, Austria
🇧🇪
UZ Gent, Gent, Belgium

and more 24 locations

A Safety and Effectiveness Study of Acetaminophen (4000 mg/Day) and Naproxen (750 mg/Day) in the Treatment of Osteoarthritis of the Hip or Knee

Phase 3

Completed

Conditions: Osteoarthritis, Hip
Osteoarthritis, Knee

Interventions: Drug: naproxen
Drug: acetaminophen

First Posted Date: 2005-10-18

Last Posted Date: 2015-06-19

Lead Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide

Target Recruit Count: 581

Registration Number: NCT00240773

Oral vs Rectal Admin of Naproxen for Post-Vag Perineal Pain Control

Phase 4

Completed

Conditions: Post-Vaginal Delivery Perineal Pain

Interventions: Drug: Naproxen

First Posted Date: 2005-09-22

Last Posted Date: 2007-11-15

Lead Sponsor: University of Saskatchewan

Target Recruit Count: 60

Registration Number: NCT00222976

Locations: 🇨🇦
Department of Anesthesia, Royal University Hospital, University of Saskatchewan, Saskatoon, Saskatchewan, Canada

A Study of Rofecoxib Versus Naproxen in the Treatment of Chinese Patient With Rheumatoid Arthritis (0966-231)

Phase 4

Completed

Conditions: Rheumatoid Arthritis

First Posted Date: 2005-09-12

Last Posted Date: 2017-05-25

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 150

Registration Number: NCT00157872

Celebrex Low Dose ASA Study Examining the Incidence of Gastroduodenal Ulcers in a Healthy Population

Phase 4

Completed

Conditions: Peptic Ulcers

First Posted Date: 2005-08-29

Last Posted Date: 2021-03-03

Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Target Recruit Count: 605

Registration Number: NCT00137033

Locations: 🇺🇸
Pfizer Investigational Site, Chesapeake, Virginia, United States

An Investigational Drug Study in the Treatment of Primary Dysmenorrhea (0663-064)

Phase 3

Completed

Conditions: Dysmenorrhea

Interventions: Drug: etoricoxib (MK0663)

First Posted Date: 2004-09-28

Last Posted Date: 2024-08-15

Lead Sponsor: Organon and Co

Target Recruit Count: 129

Registration Number: NCT00092729

Meloxicam [Mobic] in Juvenile Rheumatoid Arthritis (JRA)

Phase 3

Completed

Conditions: Arthritis, Juvenile Rheumatoid

First Posted Date: 2002-05-03

Last Posted Date: 2013-11-01

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 180

Registration Number: NCT00034853

Locations: 🇺🇸
107.235.8 Boehringer Ingelheim Investigational Site, Chicago, Illinois, United States
🇺🇸
107.235.10 Texas Scottish Rite Hospital, Dallas, Texas, United States
🇺🇸
107.235.7 Boehringer Ingelheim Investigational Site, Kansas City, Kansas, United States

and more 34 locations

Alzheimer's Disease Anti-Inflammatory Prevention Trial (ADAPT)

Phase 3

Completed

Conditions: Alzheimer Disease

First Posted Date: 2000-12-14

Last Posted Date: 2016-10-19

Lead Sponsor: Seattle Institute for Biomedical and Clinical Research

Target Recruit Count: 2625

Registration Number: NCT00007189

Locations: 🇺🇸
Boston University School of Medicine, Boston, Massachusetts, United States
🇺🇸
Johns Hopkins University, Baltimore, Maryland, United States
🇺🇸
Roskamp Institute Memory Clinic, 10770 N. 46th Street, Tampa, Florida, United States

and more 3 locations

A Multicenter Trial of Rofecoxib and Naproxen in Alzheimer's Disease (NSAID Study)

Phase 2

Completed

Conditions: Alzheimer Disease

First Posted Date: 2000-02-29

Last Posted Date: 2009-12-11

Lead Sponsor: National Institute on Aging (NIA)

Registration Number: NCT00004845

Locations: 🇺🇸
University of Southern California, Los Angeles, California, United States
🇺🇸
Medical University of South Carolina, North Charleston, South Carolina, United States
🇺🇸
University of California Irvine Institute for Brain Aging and Dementia, Irvine, California, United States

and more 37 locations

Drug Development Updates

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