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
C14H14O3
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
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Clinical Trials
Related News

Fast & Fed Pharmacokinetic (PK) Study

Phase 1
Completed
Conditions
Bioavailability
Interventions
Drug: Naproxen sodium
First Posted Date
2008-06-06
Last Posted Date
2013-05-03
Lead Sponsor
Bayer
Target Recruit Count
32
Registration Number
NCT00692016

Study Evaluating the Bioavailability of Naproxen 375 mg in Two Formulations

Phase 1
Completed
Conditions
Arthritis
Interventions
Drug: PN400
Drug: Naproxen
First Posted Date
2008-06-06
Last Posted Date
2008-09-05
Lead Sponsor
POZEN
Target Recruit Count
30
Registration Number
NCT00692055

Study to Investigate the Analgesic Efficacy of a Single Dose of AZD1386

Phase 2
Completed
Conditions
Pain
Interventions
Drug: AZD1386
Drug: Naproxen
Drug: Placebo
First Posted Date
2008-05-06
Last Posted Date
2012-06-08
Lead Sponsor
AstraZeneca
Target Recruit Count
103
Registration Number
NCT00672646
Locations
🇺🇸

Research Site, Salt Lake City, Utah, United States

Study Evaluating the Bioavailability of Naproxen 500 mg in Three Formulations

Phase 1
Completed
Conditions
Arthritis
Interventions
Drug: PN400
Drug: naproxen
First Posted Date
2008-04-24
Last Posted Date
2008-06-10
Lead Sponsor
POZEN
Target Recruit Count
30
Registration Number
NCT00665743

Study to Investigate the Analgesic Efficacy of a Single Dose of AZD1940

Phase 2
Completed
Conditions
Pain
Interventions
Drug: AZD1940
Drug: Placebo
Drug: Naproxen
First Posted Date
2008-04-16
Last Posted Date
2012-06-11
Lead Sponsor
AstraZeneca
Target Recruit Count
151
Registration Number
NCT00659490
Locations
🇺🇸

Research Site, Salt Lake City, Utah, United States

A Study to Evaluate the Efficacy and Safety of Celecoxib Suspension Compared to Naproxen Suspension in Patients With JRA

First Posted Date
2008-04-04
Last Posted Date
2008-05-30
Lead Sponsor
Pfizer
Target Recruit Count
225
Registration Number
NCT00652925
Locations
🇸🇪

Pfizer Investigational Site, Stockholm, Sweden

Double-Blind, Double Dummy, Randomized Comparison Study to Evaluate the Efficacy and Safety of Valdecoxib 10 mg Once Daily and Naproxen 500 mg Twice Daily in Treating the Signs and Symptoms of Osteoarthritis of the Knee

Phase 3
Completed
Conditions
Osteoarthritis
Knee
Interventions
Drug: naproxen
Drug: valdecoxib
First Posted Date
2008-04-04
Last Posted Date
2008-04-10
Lead Sponsor
Pfizer
Target Recruit Count
265
Registration Number
NCT00652808
Locations
🇰🇷

Pfizer Investigational Site, Seoul, Korea, Republic of

A Double-Blind, Double Dummy, Randomized Comparison Study Of The Efficacy And Safety Of Valdecoxib 10mg Once Daily And Naproxen 500mg Twice Daily In Treating The Signs And Symptoms Of Osteoarthritis Of The Knee Or Hip In Taiwan

Phase 3
Completed
Conditions
Osteoarthritis
Interventions
Drug: valdecoxib
Drug: naproxen
First Posted Date
2008-04-01
Last Posted Date
2018-12-05
Lead Sponsor
Pfizer
Target Recruit Count
130
Registration Number
NCT00648258
Locations
🇨🇳

Pfizer Investigational Site, Taipei, Taiwan

Efficacy and Safety of Valdecoxib and Naproxen in Treating the Signs and Symptoms of Rheumatoid Arthritis (RA) in a Severe Rheumatoid Arthritis Patients

First Posted Date
2008-04-01
Last Posted Date
2008-07-21
Lead Sponsor
Pfizer
Target Recruit Count
489
Registration Number
NCT00650455
Locations
🇨🇦

Pfizer Investigational Site, Saskatoon, Saskatchewan, Canada

Safety and Efficacy of Celecoxib Versus Naproxen in the 6-month Treatment of Knee Osteoarthritis

First Posted Date
2008-03-26
Last Posted Date
2021-02-02
Lead Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Target Recruit Count
586
Registration Number
NCT00643799
Locations
🇺🇸

Pfizer Investigational Site, Salt Lake City, Utah, United States

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