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

Study to Evaluate Pharmacokinetic Drug Interactions and Safety of Naproxen, Aceclofenac, Celecoxib and Ilaprazole

Phase 1

Completed

Conditions: Drug Interaction Potentiation

Interventions: Drug: Ilaprazole
Drug: Naproxen
Drug: Aceclofenac
Drug: Celecoxib

First Posted Date: 2022-02-14

Last Posted Date: 2023-06-28

Lead Sponsor: Il-Yang Pharm. Co., Ltd.

Target Recruit Count: 72

Registration Number: NCT05237297

Locations: 🇰🇷
Severance Hospital, Seoul, Korea, Republic of

Post Operative Pain Management Through Adductor Canal Block With Bupivacaine for ACL Reconstruction

Phase 3

Conditions: Pain, Postoperative
ACL

Interventions: Drug: OxyCODONE 5 mg Oral Tablet
Drug: Naproxen 500 Mg
Drug: Tylenol Pill
Drug: Liposomal bupivacaine
Procedure: Femoral Nerve Catheter

First Posted Date: 2021-12-17

Last Posted Date: 2021-12-17

Lead Sponsor: Rothman Institute Orthopaedics

Target Recruit Count: 154

Registration Number: NCT05161221

Locations: 🇺🇸
Rothman Orthopaedic Institute, Philadelphia, Pennsylvania, United States

Pain Management After Surgery

Phase 3

Conditions: Pain, Postoperative

Interventions: Drug: OxyCODONE 5 mg Oral Tablet
Drug: Acetaminophen 500Mg Tab
Drug: Naproxen 500 Mg

First Posted Date: 2021-12-13

Last Posted Date: 2021-12-13

Lead Sponsor: Rothman Institute Orthopaedics

Target Recruit Count: 200

Registration Number: NCT05154682

Locations: 🇺🇸
Rothman Orthopaedic Institute, Philadelphia, Pennsylvania, United States

Novel Non-opioid Post-surgical Pain Treatment in Females

Phase 2

Withdrawn

Conditions: Acute Pain
Toe Fusion
Bunionectomy

Interventions: Drug: Naproxen

First Posted Date: 2021-10-21

Last Posted Date: 2024-03-18

Lead Sponsor: Northwestern University

Registration Number: NCT05087914

Locations: 🇺🇸
Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States

A Clinical Trial to Compare Safety and Effectiveness for Relieving Tenderness of 10% Naproxen Gel vs. a 2.32% Diclofenac Diethylamine Gel in the Treatment of Strains and Bruises of the Legs.

Phase 2

Completed

Conditions: Soft Tissue Injury

Interventions: Drug: Placebo gel
Drug: Diclofenac gel
Drug: Naproxen gel

First Posted Date: 2021-08-30

Last Posted Date: 2025-01-22

Lead Sponsor: Bayer

Target Recruit Count: 76

Registration Number: NCT05026320

Locations: 🇩🇪
Deutsche Sporthochschule Köln (DSHS), Köln, Nordrhein-Westfalen, Germany

Treat-to-Target Serum Urate Versus Treat-to-Avoid Symptoms in Gout

Phase 4

Recruiting

Conditions: Gout

Interventions: Drug: Allopurinol
Drug: Naproxen 250 MG
Drug: Colchicine 0.6 mg
Drug: Colchicine 1.2 mg
Drug: Naproxen 500 Mg
Drug: Prednisone 40 mg

First Posted Date: 2021-05-06

Last Posted Date: 2024-09-30

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 650

Registration Number: NCT04875702

Locations: 🇺🇸
West Virginia University (Including Mobile Clinical Trials Unit), Morgantown, West Virginia, United States
🇺🇸
The University of Alabama at Birmingham, South Birmingham, Alabama, United States
🇺🇸
UCLA Health, Santa Monica, California, United States

and more 4 locations