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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, 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
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Efficacy and Safety of a Fixed-dose Combination of Naratriptan and Naproxen in Acute Treatment of Migraine

Phase 3
Withdrawn
Conditions
Migraine
Headache
Interventions
Drug: Naratriptan
Drug: Fixed-dose combination of naratriptan+naproxen
Drug: Naproxen
First Posted Date
2011-07-11
Last Posted Date
2016-10-19
Lead Sponsor
Ache Laboratorios Farmaceuticos S.A.
Registration Number
NCT01390324

Assessment of Pharmacokinetics of a Single Oral Dose of VIMOVO in Healthy Adult Volunteers

Phase 1
Completed
Conditions
Juvenile Idiopathic Arthritis
First Posted Date
2011-05-23
Last Posted Date
2012-06-22
Lead Sponsor
AstraZeneca
Target Recruit Count
28
Registration Number
NCT01358383
Locations
🇺🇸

Research Site, Overland Park, Kansas, United States

A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-39439335 in Patients With Osteoarthritis

Phase 1
Completed
Conditions
Osteoarthritis, Knee
Interventions
Drug: JNJ-39439335
Drug: Naproxen
Drug: Placebo
First Posted Date
2011-04-28
Last Posted Date
2012-08-09
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
43
Registration Number
NCT01343303

Treximet Trademark (TM) in the Prevention and Modification of Disease Progression in Migraine

Phase 4
Completed
Conditions
Migraine
Interventions
Drug: Sumatriptan/Naproxen Sodium
Drug: Naproxen Sodium
First Posted Date
2011-02-21
Last Posted Date
2013-05-21
Lead Sponsor
Cady, Roger, M.D.
Target Recruit Count
40
Registration Number
NCT01300546
Locations
🇺🇸

Newport Beach Clinical Research Assoc., Inc., Newport Beach, California, United States

🇺🇸

Clinvest, Springfield, Missouri, United States

Acute Osteoarthritis Experimental Model Study.

Phase 2
Completed
Conditions
Osteoarthritis
Interventions
Drug: Placebo
Drug: Naproxen
First Posted Date
2010-11-01
Last Posted Date
2011-01-31
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
53
Registration Number
NCT01231490
Locations
🇬🇧

GSK Investigational Site, Manchester, United Kingdom

Study of Naproxen Capsules to Treat Dental Pain

Phase 2
Completed
Conditions
Dental Pain
Interventions
First Posted Date
2010-10-27
Last Posted Date
2012-05-22
Lead Sponsor
Iroko Pharmaceuticals, LLC
Target Recruit Count
254
Registration Number
NCT01229228
Locations
🇺🇸

Premier Research Group Limited, Austin, Texas, United States

A Study of ABT-652 in Adults With Osteoarthritis Pain of the Knee

Phase 2
Completed
Conditions
Osteoarthritis of the Knee
Interventions
Drug: ABT-652
Drug: Naproxen
Drug: Placebo
First Posted Date
2010-09-22
Last Posted Date
2013-01-07
Lead Sponsor
AbbVie (prior sponsor, Abbott)
Target Recruit Count
322
Registration Number
NCT01207115
Locations
🇺🇸

Site Reference ID/Investigator# 37222, Burbank, California, United States

🇺🇸

Site Reference ID/Investigator# 37227, Milford, Connecticut, United States

🇺🇸

Site Reference ID/Investigator# 37229, Boynton Beach, Florida, United States

and more 35 locations

The Effects of Three Oral Medications on Post-operative Pain Following Endodontic Treatment

Phase 1
Completed
Conditions
Pulpitis
Pain Management
First Posted Date
2010-08-10
Last Posted Date
2010-08-10
Lead Sponsor
Azad University of Medical Sciences
Registration Number
NCT01178203

To Determine the Safety, Tolerability, Pharmacokinetics and Effect on Pain of a Single Intra-articular Administration of Canakinumab in Patients With Osteoarthritis in the Knee

Phase 2
Completed
Conditions
Osteoarthritis
Interventions
First Posted Date
2010-07-12
Last Posted Date
2012-10-30
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
169
Registration Number
NCT01160822
Locations
🇺🇸

Pinnacle Research Group, LLC, Anniston, Alabama, United States

🇺🇸

Westlake Medical Research, Westlake Village, California, United States

🇺🇸

San Diego Arthritis & Osteoporosis Medical Clinic, San Diego, California, United States

and more 6 locations

Phase I Study on Multiple Oral Dosing of CG100649

Phase 1
Completed
Conditions
Healthy
Interventions
Drug: CG100649
Drug: Placebo
Drug: Naproxen
First Posted Date
2010-07-01
Last Posted Date
2016-01-28
Lead Sponsor
CrystalGenomics, Inc.
Target Recruit Count
120
Registration Number
NCT01154790
Locations
🇰🇷

Asan Medical Center, Seoul, Korea, Republic of

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